Trial Outcomes & Findings for Adjunctive Acetylsalicylic Acid and Ibuprofen for Tuberculosis (NCT NCT04575519)

Last Updated: 2026-06-01

Results Overview

Time to SCC is defined as the time until at least 2 consecutive negative cultures for M. tuberculosis at least 4 weeks apart during the first 24 weeks of TB treatment.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

426 participants

Primary outcome timeframe

24 weeks of TB treatment

Results posted on

2026-06-01

Participant Flow

205 were excluded mainly due to: lack of microbiological TB confirmation; HIV-related exclusion criteria; major comorbid conditions or investigator's decision; prior TB treatment; ALT/AST above threshold; body weight, haemoglobin or neutrophil below threshold; alcohol use; age outside the range; allergy to NSAIDs; use of antacids; proton pump inhibitors or immune-modulating therapy; multiple exclusion criteria.

Participant milestones

Participant milestones
Measure	Control Group Standard of Care (SoC) TB treatment + placebo twice daily during first 4 weeks of TB treatment followed by placebo once daily for an additional 4 weeks. Control group: placebo 2 months treatment: 2 tablets during 4 weeks + 1 tablet during 4 weeks SoC TB: Standard of Care Tuberculosis treatment	SoC TB + ASA Group Standard of Care (SoC) TB treatment + acetylsalicylic acid 300mg twice daily during first 4 weeks of TB treatment followed by aspirin 300mg once daily for an additional 4 weeks. ASA group: Acetylsalicylic acid 2 months treatment: 2 tablets during 4 weeks (600 mg daily) + 1 tablet during 4 weeks (300 mg daily) SoC TB: Standard of Care Tuberculosis treatment	SoC TB + IBU Group Standard of Care (SoC) TB treatment + ibuprofen 400mg twice daily during first 4 weeks of TB treatment followed by ibuprofen 400mg once daily for an additional 4 weeks IBU group: Ibuprofen 2 months treatment: 2 tablets during 4 weeks (800 mg daily) + 1 tablet during 4 weeks (400 mg daily) SoC TB: Standard of Care Tuberculosis treatment
Overall Study STARTED	73	74	74
Overall Study COMPLETED	63	62	59
Overall Study NOT COMPLETED	10	12	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Group Standard of Care (SoC) TB treatment + placebo twice daily during first 4 weeks of TB treatment followed by placebo once daily for an additional 4 weeks. Control group: placebo 2 months treatment: 2 tablets during 4 weeks + 1 tablet during 4 weeks SoC TB: Standard of Care Tuberculosis treatment	SoC TB + ASA Group Standard of Care (SoC) TB treatment + acetylsalicylic acid 300mg twice daily during first 4 weeks of TB treatment followed by aspirin 300mg once daily for an additional 4 weeks. ASA group: Acetylsalicylic acid 2 months treatment: 2 tablets during 4 weeks (600 mg daily) + 1 tablet during 4 weeks (300 mg daily) SoC TB: Standard of Care Tuberculosis treatment	SoC TB + IBU Group Standard of Care (SoC) TB treatment + ibuprofen 400mg twice daily during first 4 weeks of TB treatment followed by ibuprofen 400mg once daily for an additional 4 weeks IBU group: Ibuprofen 2 months treatment: 2 tablets during 4 weeks (800 mg daily) + 1 tablet during 4 weeks (400 mg daily) SoC TB: Standard of Care Tuberculosis treatment
Overall Study Late exclusion	5	5	3
Overall Study Withdrawal by Subject	1	1	2
Overall Study Physician Decision	0	0	2
Overall Study Lost to Follow-up	0	3	3
Overall Study Relocation	3	3	3
Overall Study Death	1	0	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=73 Participants Standard of Care (SoC) TB treatment + placebo twice daily during first 4 weeks of TB treatment followed by placebo once daily for an additional 4 weeks. Control group: placebo 2 months treatment: 2 tablets during 4 weeks + 1 tablet during 4 weeks SoC TB: Standard of Care Tuberculosis treatment	SoC TB + ASA Group n=74 Participants Standard of Care (SoC) TB treatment + acetylsalicylic acid 300mg twice daily during first 4 weeks of TB treatment followed by aspirin 300mg once daily for an additional 4 weeks. ASA group: Acetylsalicylic acid 2 months treatment: 2 tablets during 4 weeks (600 mg daily) + 1 tablet during 4 weeks (300 mg daily) SoC TB: Standard of Care Tuberculosis treatment	SoC TB + IBU Group n=74 Participants Standard of Care (SoC) TB treatment + ibuprofen 400mg twice daily during first 4 weeks of TB treatment followed by ibuprofen 400mg once daily for an additional 4 weeks IBU group: Ibuprofen 2 months treatment: 2 tablets during 4 weeks (800 mg daily) + 1 tablet during 4 weeks (400 mg daily) SoC TB: Standard of Care Tuberculosis treatment	Total n=221 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=73 Participants	0 Participants n=74 Participants	0 Participants n=74 Participants	0 Participants n=221 Participants
Age, Categorical Between 18 and 65 years	73 Participants n=73 Participants	74 Participants n=74 Participants	74 Participants n=74 Participants	221 Participants n=221 Participants
Age, Categorical >=65 years	0 Participants n=73 Participants	0 Participants n=74 Participants	0 Participants n=74 Participants	0 Participants n=221 Participants
Sex: Female, Male Female	20 Participants n=73 Participants	21 Participants n=74 Participants	21 Participants n=74 Participants	62 Participants n=221 Participants
Sex: Female, Male Male	53 Participants n=73 Participants	53 Participants n=74 Participants	53 Participants n=74 Participants	159 Participants n=221 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment South Africa	48 participants n=73 Participants	48 participants n=74 Participants	50 participants n=74 Participants	146 participants n=221 Participants
Region of Enrollment Georgia	25 participants n=73 Participants	26 participants n=74 Participants	24 participants n=74 Participants	75 participants n=221 Participants
Drug susceptibility Drug-susceptible TB	64 Participants n=73 Participants	64 Participants n=74 Participants	66 Participants n=74 Participants	194 Participants n=221 Participants
Drug susceptibility Multidrug-resistant TB	9 Participants n=73 Participants	10 Participants n=74 Participants	8 Participants n=74 Participants	27 Participants n=221 Participants

PRIMARY outcome

Timeframe: 24 weeks of TB treatment

Population: Of the 221 participants enrolled, 204 participants had at least one post-baseline outcome assessment and are included in the outcome measure. 17 participants discontinued after baseline and had no post-baseline assessments. All collected data for the pre-specified outcome are reported in the outcome measure.

Time taken to reach 67% sustained reduction in the TB score over the course of TB treatment. Minimum value of the score = 0; Maximum value = 13). Higher scores mean a better or worse outcome. Difference between each intervention arm and control group were analysed. The TB Score has been described to be useful to monitor good response to TB treatment, regardless of HIV status.

Outcome measures

Outcome measures
Measure	Control Group n=67 Participants Standard of Care (SoC) TB treatment + placebo twice daily during first 4 weeks of TB treatment followed by placebo once daily for an additional 4 weeks. Control group: placebo 2 months treatment: 2 tablets during 4 weeks + 1 tablet during 4 weeks SoC TB: Standard of Care Tuberculosis treatment	SoC TB + ASA Group n=69 Participants Standard of Care (SoC) TB treatment + acetylsalicylic acid 300mg twice daily during first 4 weeks of TB treatment followed by aspirin 300mg once daily for an additional 4 weeks. ASA group: Acetylsalicylic acid 2 months treatment: 2 tablets during 4 weeks (600 mg daily) + 1 tablet during 4 weeks (300 mg daily) SoC TB: Standard of Care Tuberculosis treatment	SoC TB + IBU Group n=68 Participants Standard of Care (SoC) TB treatment + ibuprofen 400mg twice daily during first 4 weeks of TB treatment followed by ibuprofen 400mg once daily for an additional 4 weeks IBU group: Ibuprofen 2 months treatment: 2 tablets during 4 weeks (800 mg daily) + 1 tablet during 4 weeks (400 mg daily) SoC TB: Standard of Care Tuberculosis treatment
Time to ≥ 67% Sustained Reduction in the TB Score	5 weeks Interval 4.0 to 7.1	4.9 weeks Interval 3.0 to 6.0	4.1 weeks Interval 3.1 to 6.7

PRIMARY outcome

Timeframe: 24 weeks of TB treatment

Time to SCC is defined as the time until at least 2 consecutive negative cultures for M. tuberculosis at least 4 weeks apart during the first 24 weeks of TB treatment.

Outcome measures

Outcome measures
Measure	Control Group n=67 Participants Standard of Care (SoC) TB treatment + placebo twice daily during first 4 weeks of TB treatment followed by placebo once daily for an additional 4 weeks. Control group: placebo 2 months treatment: 2 tablets during 4 weeks + 1 tablet during 4 weeks SoC TB: Standard of Care Tuberculosis treatment	SoC TB + ASA Group n=69 Participants Standard of Care (SoC) TB treatment + acetylsalicylic acid 300mg twice daily during first 4 weeks of TB treatment followed by aspirin 300mg once daily for an additional 4 weeks. ASA group: Acetylsalicylic acid 2 months treatment: 2 tablets during 4 weeks (600 mg daily) + 1 tablet during 4 weeks (300 mg daily) SoC TB: Standard of Care Tuberculosis treatment	SoC TB + IBU Group n=68 Participants Standard of Care (SoC) TB treatment + ibuprofen 400mg twice daily during first 4 weeks of TB treatment followed by ibuprofen 400mg once daily for an additional 4 weeks IBU group: Ibuprofen 2 months treatment: 2 tablets during 4 weeks (800 mg daily) + 1 tablet during 4 weeks (400 mg daily) SoC TB: Standard of Care Tuberculosis treatment
Time to Stable Culture Conversion (SCC)	8 weeks Interval 8.0 to 11.1	8 weeks Interval 7.9 to 8.1	8 weeks Interval 6.1 to 8.0

SECONDARY outcome

Timeframe: Week 8 and Week 16

Time to SCC is defined as the time until at least 2 consecutive negative cultures for M. tuberculosis at least 4 weeks apart. For this secondary outcome, differences between groups were analyzed at week 8 and week 16

Outcome measures

Outcome measures
Measure	Control Group n=67 Participants Standard of Care (SoC) TB treatment + placebo twice daily during first 4 weeks of TB treatment followed by placebo once daily for an additional 4 weeks. Control group: placebo 2 months treatment: 2 tablets during 4 weeks + 1 tablet during 4 weeks SoC TB: Standard of Care Tuberculosis treatment	SoC TB + ASA Group n=69 Participants Standard of Care (SoC) TB treatment + acetylsalicylic acid 300mg twice daily during first 4 weeks of TB treatment followed by aspirin 300mg once daily for an additional 4 weeks. ASA group: Acetylsalicylic acid 2 months treatment: 2 tablets during 4 weeks (600 mg daily) + 1 tablet during 4 weeks (300 mg daily) SoC TB: Standard of Care Tuberculosis treatment	SoC TB + IBU Group n=68 Participants Standard of Care (SoC) TB treatment + ibuprofen 400mg twice daily during first 4 weeks of TB treatment followed by ibuprofen 400mg once daily for an additional 4 weeks IBU group: Ibuprofen 2 months treatment: 2 tablets during 4 weeks (800 mg daily) + 1 tablet during 4 weeks (400 mg daily) SoC TB: Standard of Care Tuberculosis treatment
Time to a Stable Culture Conversion (SCC) at Week 8 and Week 16 After Treatment Initiation Week 8	8 weeks Interval 8.0 to 8.0	8 weeks Interval 7.9 to 8.0	8 weeks Interval 6.1 to 8.0
Time to a Stable Culture Conversion (SCC) at Week 8 and Week 16 After Treatment Initiation Week 16	8 weeks Interval 8.0 to 11.1	8 weeks Interval 7.9 to 8.1	8 weeks Interval 6.1 to 8.0

SECONDARY outcome

Timeframe: Baseline, week 8 and week 24

Population: Of the 221 participants enrolled in the trial, 189 had TB score data available at baseline, week 8 and week 24 and were included in the secondary outcome analysis. 17 participants discontinued after baseline and had no post-baseline assessments. 15 participants did not have TB score data available at baseline, week 8 and/or week 24. All collected data for the pre-specified outcome are reported in the outcome measure.

Signs and symptoms were assessed using the TB Score (TBS), which ranges from 0 to 13, with higher scores indicating more severe disease. The outcome was defined as the proportion of participants achieving a ≥50% reduction from baseline in TBS at Week 8 and a ≥75% reduction from baseline in TBS at Week 24. Comparisons were performed between each intervention arm and the control group. TBS has been described as a useful tool for monitoring clinical response to tuberculosis treatment.

Outcome measures

Outcome measures
Measure	Control Group n=63 Participants Standard of Care (SoC) TB treatment + placebo twice daily during first 4 weeks of TB treatment followed by placebo once daily for an additional 4 weeks. Control group: placebo 2 months treatment: 2 tablets during 4 weeks + 1 tablet during 4 weeks SoC TB: Standard of Care Tuberculosis treatment	SoC TB + ASA Group n=66 Participants Standard of Care (SoC) TB treatment + acetylsalicylic acid 300mg twice daily during first 4 weeks of TB treatment followed by aspirin 300mg once daily for an additional 4 weeks. ASA group: Acetylsalicylic acid 2 months treatment: 2 tablets during 4 weeks (600 mg daily) + 1 tablet during 4 weeks (300 mg daily) SoC TB: Standard of Care Tuberculosis treatment	SoC TB + IBU Group n=60 Participants Standard of Care (SoC) TB treatment + ibuprofen 400mg twice daily during first 4 weeks of TB treatment followed by ibuprofen 400mg once daily for an additional 4 weeks IBU group: Ibuprofen 2 months treatment: 2 tablets during 4 weeks (800 mg daily) + 1 tablet during 4 weeks (400 mg daily) SoC TB: Standard of Care Tuberculosis treatment
Improvement or Resolution of Clinical Signs and Symptoms Week 8	42 Participants	47 Participants	46 Participants
Improvement or Resolution of Clinical Signs and Symptoms Week 24	44 Participants	48 Participants	42 Participants

SECONDARY outcome

Timeframe: Baseline, week 8 and week 24

Population: Our analysis was limited to participants from the Georgian site because lung function was assessed exclusively at that site. This population included DS and MDR participants. Of the 75 participants in the Georgian site, 54 had FEV1 data available at both baseline and week 24 and were included in this secondary outcome analysis.

Improvement of lung function in the 1-second forced expiratory volume (FEV1)

Outcome measures

Outcome measures
Measure	Control Group n=21 Participants Standard of Care (SoC) TB treatment + placebo twice daily during first 4 weeks of TB treatment followed by placebo once daily for an additional 4 weeks. Control group: placebo 2 months treatment: 2 tablets during 4 weeks + 1 tablet during 4 weeks SoC TB: Standard of Care Tuberculosis treatment	SoC TB + ASA Group n=22 Participants Standard of Care (SoC) TB treatment + acetylsalicylic acid 300mg twice daily during first 4 weeks of TB treatment followed by aspirin 300mg once daily for an additional 4 weeks. ASA group: Acetylsalicylic acid 2 months treatment: 2 tablets during 4 weeks (600 mg daily) + 1 tablet during 4 weeks (300 mg daily) SoC TB: Standard of Care Tuberculosis treatment	SoC TB + IBU Group n=21 Participants Standard of Care (SoC) TB treatment + ibuprofen 400mg twice daily during first 4 weeks of TB treatment followed by ibuprofen 400mg once daily for an additional 4 weeks IBU group: Ibuprofen 2 months treatment: 2 tablets during 4 weeks (800 mg daily) + 1 tablet during 4 weeks (400 mg daily) SoC TB: Standard of Care Tuberculosis treatment
Improvement of Lung Function Baseline	3.10 FEV1 Interval 2.64 to 4.18	3.06 FEV1 Interval 2.65 to 3.73	3.85 FEV1 Interval 2.88 to 4.35
Improvement of Lung Function Week 8	3.12 FEV1 Interval 2.59 to 3.7	3.20 FEV1 Interval 2.63 to 3.88	3.86 FEV1 Interval 3.01 to 4.3
Improvement of Lung Function Week 24	3.25 FEV1 Interval 2.7 to 4.14	3.24 FEV1 Interval 2.72 to 3.82	3.84 FEV1 Interval 3.15 to 4.17

SECONDARY outcome

Timeframe: Baseline, week 8 and week 24

Population: Of the 221 participants enrolled in the trial, 196 had activity component data of the RTBES available at both baseline and week 8, and 180 at baseline and week 24. All collected data for the pre-specified outcome are reported in the outcome measure and were included in the secondary outcome analysis. 17 participants discontinued after baseline and had no post-baseline assessments. 24 participants did not have activity component data of RTBES available at baseline, week 8 and/or week 24.

Changes in chest X-ray (CXR) findings were assessed using the Activity component of the RUTI TB Evolution Score (RTBES). The baseline CXR served as the reference for comparison with subsequent CXRs obtained during tuberculosis treatment. The Activity component ranges from 0 to 38, with higher scores indicating more severe radiographic involvement. The outcome was defined as the proportion of participants achieving a ≥50% reduction from baseline in the Activity component at Week 8 and a ≥75% reduction from baseline at Week 24. Comparisons were performed between each intervention arm and the control group.

Outcome measures

Outcome measures
Measure	Control Group n=67 Participants Standard of Care (SoC) TB treatment + placebo twice daily during first 4 weeks of TB treatment followed by placebo once daily for an additional 4 weeks. Control group: placebo 2 months treatment: 2 tablets during 4 weeks + 1 tablet during 4 weeks SoC TB: Standard of Care Tuberculosis treatment	SoC TB + ASA Group n=65 Participants Standard of Care (SoC) TB treatment + acetylsalicylic acid 300mg twice daily during first 4 weeks of TB treatment followed by aspirin 300mg once daily for an additional 4 weeks. ASA group: Acetylsalicylic acid 2 months treatment: 2 tablets during 4 weeks (600 mg daily) + 1 tablet during 4 weeks (300 mg daily) SoC TB: Standard of Care Tuberculosis treatment	SoC TB + IBU Group n=64 Participants Standard of Care (SoC) TB treatment + ibuprofen 400mg twice daily during first 4 weeks of TB treatment followed by ibuprofen 400mg once daily for an additional 4 weeks IBU group: Ibuprofen 2 months treatment: 2 tablets during 4 weeks (800 mg daily) + 1 tablet during 4 weeks (400 mg daily) SoC TB: Standard of Care Tuberculosis treatment
Reduction of the Activity Component of the RTBES Week 24	40 Participants	42 Participants	36 Participants
Reduction of the Activity Component of the RTBES Week 8	34 Participants	32 Participants	23 Participants

SECONDARY outcome

Timeframe: Baseline, week 8 and week 24

Population: Of the 221 participants enrolled in the trial, 112 had SGRQ score data available at baseline and week 8 and 126 at baseline and week 24, and were included in the secondary outcome analysis. 17 participants discontinued after baseline and had no post-baseline assessments. 78 participants did not have SGRQ score data available at baseline, week 8 and/or week 24. All collected data for the pre-specified outcome are reported in the outcome measure.

Number of patients showing improvement in health-related quality of life at weeks 8 and 24 compared to baseline, as measured by the Saint Georges Respiratory Questionnaire (SGRQ). The SGRQ score ranges from 0 (best) to 100 (worst), with scores up to 7 considered to be within the healthy range. Improvement in this study being defined as achieving a score within the healthy range.

Outcome measures

Outcome measures
Measure	Control Group n=43 Participants Standard of Care (SoC) TB treatment + placebo twice daily during first 4 weeks of TB treatment followed by placebo once daily for an additional 4 weeks. Control group: placebo 2 months treatment: 2 tablets during 4 weeks + 1 tablet during 4 weeks SoC TB: Standard of Care Tuberculosis treatment	SoC TB + ASA Group n=42 Participants Standard of Care (SoC) TB treatment + acetylsalicylic acid 300mg twice daily during first 4 weeks of TB treatment followed by aspirin 300mg once daily for an additional 4 weeks. ASA group: Acetylsalicylic acid 2 months treatment: 2 tablets during 4 weeks (600 mg daily) + 1 tablet during 4 weeks (300 mg daily) SoC TB: Standard of Care Tuberculosis treatment	SoC TB + IBU Group n=41 Participants Standard of Care (SoC) TB treatment + ibuprofen 400mg twice daily during first 4 weeks of TB treatment followed by ibuprofen 400mg once daily for an additional 4 weeks IBU group: Ibuprofen 2 months treatment: 2 tablets during 4 weeks (800 mg daily) + 1 tablet during 4 weeks (400 mg daily) SoC TB: Standard of Care Tuberculosis treatment
Improvement of Health-related Quality of Life Week 8	16 Participants	14 Participants	17 Participants
Improvement of Health-related Quality of Life Week 24	32 Participants	35 Participants	31 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 24

Population: All participants enrolled in the trial were included in the safety analysis (n=221).

Proportion of participants with at least one Serious Adverse Event by arm until the end of tuberculosis (TB) treatment, between each intervention arm and the control group.

Outcome measures

Outcome measures
Measure	Control Group n=73 Participants Standard of Care (SoC) TB treatment + placebo twice daily during first 4 weeks of TB treatment followed by placebo once daily for an additional 4 weeks. Control group: placebo 2 months treatment: 2 tablets during 4 weeks + 1 tablet during 4 weeks SoC TB: Standard of Care Tuberculosis treatment	SoC TB + ASA Group n=74 Participants Standard of Care (SoC) TB treatment + acetylsalicylic acid 300mg twice daily during first 4 weeks of TB treatment followed by aspirin 300mg once daily for an additional 4 weeks. ASA group: Acetylsalicylic acid 2 months treatment: 2 tablets during 4 weeks (600 mg daily) + 1 tablet during 4 weeks (300 mg daily) SoC TB: Standard of Care Tuberculosis treatment	SoC TB + IBU Group n=74 Participants Standard of Care (SoC) TB treatment + ibuprofen 400mg twice daily during first 4 weeks of TB treatment followed by ibuprofen 400mg once daily for an additional 4 weeks IBU group: Ibuprofen 2 months treatment: 2 tablets during 4 weeks (800 mg daily) + 1 tablet during 4 weeks (400 mg daily) SoC TB: Standard of Care Tuberculosis treatment
Safety 1: Serious Adverse Events Participant Proportion	8 Participants	6 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to week 12

Population: All participants enrolled in the trial were included in the safety analysis (n=221).

Serious adverse events rate expressed as events per 100-person week, starting the day of the first dose of NSAID or placebo until one month (30 days) after the last placebo or NSAID taken

Outcome measures

Outcome measures
Measure	Control Group n=73 Participants Standard of Care (SoC) TB treatment + placebo twice daily during first 4 weeks of TB treatment followed by placebo once daily for an additional 4 weeks. Control group: placebo 2 months treatment: 2 tablets during 4 weeks + 1 tablet during 4 weeks SoC TB: Standard of Care Tuberculosis treatment	SoC TB + ASA Group n=74 Participants Standard of Care (SoC) TB treatment + acetylsalicylic acid 300mg twice daily during first 4 weeks of TB treatment followed by aspirin 300mg once daily for an additional 4 weeks. ASA group: Acetylsalicylic acid 2 months treatment: 2 tablets during 4 weeks (600 mg daily) + 1 tablet during 4 weeks (300 mg daily) SoC TB: Standard of Care Tuberculosis treatment	SoC TB + IBU Group n=74 Participants Standard of Care (SoC) TB treatment + ibuprofen 400mg twice daily during first 4 weeks of TB treatment followed by ibuprofen 400mg once daily for an additional 4 weeks IBU group: Ibuprofen 2 months treatment: 2 tablets during 4 weeks (800 mg daily) + 1 tablet during 4 weeks (400 mg daily) SoC TB: Standard of Care Tuberculosis treatment
Safety 2: Serious Adverse Event Rate Per Person Time	0.5 events per 100-person week Interval 0.1 to 1.2	0.7 events per 100-person week Interval 0.3 to 1.5	0.4 events per 100-person week Interval 0.1 to 1.0

Adverse Events

Control Group

Serious events: 10 serious events

Other events: 17 other events

Deaths: 1 deaths

SoC TB + ASA Group

Serious events: 8 serious events

Other events: 19 other events

Deaths: 0 deaths

SoC TB + IBU Group

Serious events: 4 serious events

Other events: 12 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Control Group n=73 participants at risk Standard of Care (SoC) TB treatment + placebo twice daily during first 4 weeks of TB treatment followed by placebo once daily for an additional 4 weeks. Control group: placebo 2 months treatment: 2 tablets during 4 weeks + 1 tablet during 4 weeks SoC TB: Standard of Care Tuberculosis treatment	SoC TB + ASA Group n=74 participants at risk Standard of Care (SoC) TB treatment + acetylsalicylic acid 300mg twice daily during first 4 weeks of TB treatment followed by aspirin 300mg once daily for an additional 4 weeks. ASA group: Acetylsalicylic acid 2 months treatment: 2 tablets during 4 weeks (600 mg daily) + 1 tablet during 4 weeks (300 mg daily) SoC TB: Standard of Care Tuberculosis treatment	SoC TB + IBU Group n=74 participants at risk Standard of Care (SoC) TB treatment + ibuprofen 400mg twice daily during first 4 weeks of TB treatment followed by ibuprofen 400mg once daily for an additional 4 weeks IBU group: Ibuprofen 2 months treatment: 2 tablets during 4 weeks (800 mg daily) + 1 tablet during 4 weeks (400 mg daily) SoC TB: Standard of Care Tuberculosis treatment
Hepatobiliary disorders Hepatitis toxic drug-induced	5.5% 4/73 • Number of events 4 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	8.1% 6/74 • Number of events 6 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	5.4% 4/74 • Number of events 4 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).
Blood and lymphatic system disorders Hypertension	6.8% 5/73 • Number of events 6 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	4.1% 3/74 • Number of events 3 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	2.7% 2/74 • Number of events 2 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).
Gastrointestinal disorders Dyspepsia	2.7% 2/73 • Number of events 2 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	5.4% 4/74 • Number of events 5 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	2.7% 2/74 • Number of events 2 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).
Gastrointestinal disorders Gastrooesophageal reflux disease	1.4% 1/73 • Number of events 1 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	5.4% 4/74 • Number of events 5 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	1.4% 1/74 • Number of events 1 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).
Blood and lymphatic system disorders Anaemia	6.8% 5/73 • Number of events 5 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	2.7% 2/74 • Number of events 3 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	4.1% 3/74 • Number of events 3 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).

Additional Information

Dr. Cristina Vilaplana, Head of the Experimental TB Unit

Fundació i Hospital Germans Trias i Pujol (IGTP-HUGTIP)

Phone: (+34) 93 033 0527

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Control Group n=73 participants at risk Standard of Care (SoC) TB treatment + placebo twice daily during first 4 weeks of TB treatment followed by placebo once daily for an additional 4 weeks. Control group: placebo 2 months treatment: 2 tablets during 4 weeks + 1 tablet during 4 weeks SoC TB: Standard of Care Tuberculosis treatment	SoC TB + ASA Group n=74 participants at risk Standard of Care (SoC) TB treatment + acetylsalicylic acid 300mg twice daily during first 4 weeks of TB treatment followed by aspirin 300mg once daily for an additional 4 weeks. ASA group: Acetylsalicylic acid 2 months treatment: 2 tablets during 4 weeks (600 mg daily) + 1 tablet during 4 weeks (300 mg daily) SoC TB: Standard of Care Tuberculosis treatment	SoC TB + IBU Group n=74 participants at risk Standard of Care (SoC) TB treatment + ibuprofen 400mg twice daily during first 4 weeks of TB treatment followed by ibuprofen 400mg once daily for an additional 4 weeks IBU group: Ibuprofen 2 months treatment: 2 tablets during 4 weeks (800 mg daily) + 1 tablet during 4 weeks (400 mg daily) SoC TB: Standard of Care Tuberculosis treatment
Gastrointestinal disorders Acute peritonitis	1.4% 1/73 • Number of events 1 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	0.00% 0/74 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	0.00% 0/74 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).
Blood and lymphatic system disorders Anaemia	0.00% 0/73 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	1.4% 1/74 • Number of events 1 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	0.00% 0/74 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).
Hepatobiliary disorders Toxic drug-induced hepatitis	1.4% 1/73 • Number of events 1 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	4.1% 3/74 • Number of events 3 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	1.4% 1/74 • Number of events 1 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).
Infections and infestations TB Empyema	0.00% 0/73 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	1.4% 1/74 • Number of events 1 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	0.00% 0/74 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).
Respiratory, thoracic and mediastinal disorders Hydropneumothorax	1.4% 1/73 • Number of events 1 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	0.00% 0/74 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	0.00% 0/74 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).
Respiratory, thoracic and mediastinal disorders Haemoptysis	1.4% 1/73 • Number of events 1 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	0.00% 0/74 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	0.00% 0/74 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).
Eye disorders Conjunctival deposit	0.00% 0/73 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	0.00% 0/74 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	1.4% 1/74 • Number of events 1 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).
Gastrointestinal disorders Acute gastroenteritis	0.00% 0/73 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	1.4% 1/74 • Number of events 1 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	0.00% 0/74 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).
General disorders Death	1.4% 1/73 • Number of events 1 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	0.00% 0/74 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	2.7% 2/74 • Number of events 2 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).
Musculoskeletal and connective tissue disorders Arm fracture	1.4% 1/73 • Number of events 1 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	0.00% 0/74 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	0.00% 0/74 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).
Infections and infestations COVID-19	1.4% 1/73 • Number of events 1 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	0.00% 0/74 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	0.00% 0/74 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).
Infections and infestations TB spine	1.4% 1/73 • Number of events 1 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	0.00% 0/74 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	0.00% 0/74 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).
Respiratory, thoracic and mediastinal disorders Chest pain	1.4% 1/73 • Number of events 1 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	0.00% 0/74 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	0.00% 0/74 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).
Respiratory, thoracic and mediastinal disorders TB complications	0.00% 0/73 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	1.4% 1/74 • Number of events 1 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	0.00% 0/74 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).
Metabolism and nutrition disorders Hyperglycemia	1.4% 1/73 • Number of events 1 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	0.00% 0/74 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	0.00% 0/74 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).
Infections and infestations TB treatment failure	0.00% 0/73 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	1.4% 1/74 • Number of events 1 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).	0.00% 0/74 • The whole study period (6 months after end of TB treatment) Adverse events and serious adverse events were categorized according to the Medical Dictionary for Regulatory Activities and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 2.1).