Trial Outcomes & Findings for A Phase 2 Study of APX-115 in Hospitalized Patients With Confirmed Mild to Moderate COVID-19. (NCT NCT04880109)
NCT ID: NCT04880109
Last Updated: 2026-06-10
Results Overview
Adverse events will be assessed to evaluate the safety and tolerability of APX-115 in mild-to-moderate COVID-19 patients. Clinical laboratory evaluations, vital signs, and ECG will be used to assess adverse events.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
over the 60-day period
Results posted on
2026-06-10
Participant Flow
The study was conducted at 6 study centers in the US from 20 Oct 2021 to 28 Apr 2022 (Last Participant Last Visit). The sponsor decided to discontinue/terminate the study on 14 Apr 2023 due to an inability to recruit subjects from a shift in the COVID-19 pandemic.
A total of 16 patients were randomized to treatment in the sentinel cohort. Of these, 8 patients were administered at least 1 dose of APX-115, 7 patients were administered at least 1 dose of placebo, and 1 patient was randomized in error.
Participant milestones
| Measure |
APX-115
Oral administration of APX-115 100mg, daily for 14 days
|
Placebo
Oral administration of Placebo, daily for 14 days
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
APX-115
Oral administration of APX-115 100mg, daily for 14 days
|
Placebo
Oral administration of Placebo, daily for 14 days
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
PATIENT DID NOT MEET INCLUSION/EXCLUSION
|
0
|
1
|
Baseline Characteristics
A Phase 2 Study of APX-115 in Hospitalized Patients With Confirmed Mild to Moderate COVID-19.
Baseline characteristics by cohort
| Measure |
APX-115
n=8 Participants
Oral administration of APX-115 100mg, daily for 14 days
|
Placebo
n=8 Participants
Oral administration of Placebo, daily for 14 days
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
58.0 Years
STANDARD_DEVIATION 7.95 • n=9 Participants
|
60.5 Years
STANDARD_DEVIATION 11.5 • n=27 Participants
|
59.3 Years
STANDARD_DEVIATION 9.64 • n=267 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
12 Participants
n=267 Participants
|
|
Height
|
180.663 cm
STANDARD_DEVIATION 8.1838 • n=9 Participants
|
167.283 cm
STANDARD_DEVIATION 10.0921 • n=27 Participants
|
174.419 cm
STANDARD_DEVIATION 11.1747 • n=267 Participants
|
|
Weight
|
107.36 kg
STANDARD_DEVIATION 19.125 • n=9 Participants
|
92.61 kg
STANDARD_DEVIATION 24.804 • n=27 Participants
|
100.48 kg
STANDARD_DEVIATION 22.462 • n=267 Participants
|
PRIMARY outcome
Timeframe: over the 60-day periodPopulation: The study was terminated early due to recruitment challenges during the COVID-19 pandemic. As a result, the planned number of participants was not reached, and sufficient data could not be collected for the study. 8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
Adverse events will be assessed to evaluate the safety and tolerability of APX-115 in mild-to-moderate COVID-19 patients. Clinical laboratory evaluations, vital signs, and ECG will be used to assess adverse events.
Outcome measures
| Measure |
Placebo
n=7 Participants
Oral administration of Placebo, daily for 14 days
|
APX-115
n=8 Participants
Oral administration of APX-115 100mg, daily for 14 days
|
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events
Any study treatment related TEAE · Any TEAE
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Adverse Events
Treatment Emergent Adverse Event · Any TEAE
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 29 DaysPopulation: The study was terminated early due to recruitment challenges during the COVID-19 pandemic. As a result, the planned number of participants was not reached, and sufficient data could not be collected for the study.
Recovery is defined as when WHO Clinical Improvement Ordinal Scale equal to or less than 3. WHO Clinical Improvement Ordinal Scale Uninfected : -No clinical or virological evidence of infection 0 Ambulatory: * No limitation of activities 1 * Limitation of activities 2 Hospitalized Mild disease: * Hospitalized, no oxygen therapy 3 * Oxygen by mask or nasal prongs 4 Hospitalized Severe Disease: * Non-invasive ventilation or high-flow oxygen 5 * Intubation and mechanical ventilation 6 * Ventilation + additional organ support - pressors, RRT, ECMO 7 Dead : \- Death 8
Outcome measures
| Measure |
Placebo
n=8 Participants
Oral administration of Placebo, daily for 14 days
|
APX-115
n=8 Participants
Oral administration of APX-115 100mg, daily for 14 days
|
|---|---|---|
|
Time to Clinical Recovery
|
10.5 days
Interval 3.0 to
The upper limit of the 95% CI were not reached.
|
NA days
Interval 4.0 to
The median and upper limit of the 95% CI were not reached.
|
SECONDARY outcome
Timeframe: Up to Day 29Population: The study was terminated early due to recruitment challenges during the COVID-19 pandemic. As a result, the planned number of participants was not reached, and sufficient data could not be collected for the study.
WHO Clinical Improvement Ordinal Scale is equal to or less than 2. WHO Clinical Improvement Ordinal Scale Uninfected : -No clinical or virological evidence of infection 0 Ambulatory: * No limitation of activities 1 * Limitation of activities 2 Hospitalized Mild disease: * Hospitalized, no oxygen therapy 3 * Oxygen by mask or nasal prongs 4 Hospitalized Severe Disease: * Non-invasive ventilation or high-flow oxygen 5 * Intubation and mechanical ventilation 6 * Ventilation + additional organ support - pressors, RRT, ECMO 7 Dead : \- Death 8
Outcome measures
| Measure |
Placebo
n=8 Participants
Oral administration of Placebo, daily for 14 days
|
APX-115
n=8 Participants
Oral administration of APX-115 100mg, daily for 14 days
|
|---|---|---|
|
Time to Discharge
|
14 days
Interval 3.0 to
The upper limit of the 95% CI were not reached.
|
NA days
Interval 4.0 to
The median and upper limit of the 95% CI were not reached.
|
SECONDARY outcome
Timeframe: up to 29 daysPopulation: The study was terminated early due to recruitment challenges during the COVID-19 pandemic. As a result, the planned number of participants was not reached, and sufficient data could not be collected for the study.
Symptom Assessment of patients in clinical recovery
Outcome measures
| Measure |
Placebo
n=8 Participants
Oral administration of Placebo, daily for 14 days
|
APX-115
n=8 Participants
Oral administration of APX-115 100mg, daily for 14 days
|
|---|---|---|
|
Proportion of Patients in Clinical Recovery
|
0.625 Proportion of participants
|
0.5 Proportion of participants
|
Adverse Events
APX-115
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
APX-115
n=8 participants at risk
Oral administration of APX-115 100mg, daily for 14 days
|
Placebo
n=7 participants at risk
Oral administration of Placebo, daily for 14 days
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
12.5%
1/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
14.3%
1/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
Other adverse events
| Measure |
APX-115
n=8 participants at risk
Oral administration of APX-115 100mg, daily for 14 days
|
Placebo
n=7 participants at risk
Oral administration of Placebo, daily for 14 days
|
|---|---|---|
|
Cardiac disorders
Supraventricular tachycardia
|
12.5%
1/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
0.00%
0/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Cardiac disorders
Ventricular tachycardia
|
12.5%
1/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
0.00%
0/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
14.3%
1/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Gastrointestinal disorders
Pancreatitis
|
12.5%
1/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
0.00%
0/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
14.3%
1/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Blood and lymphatic system disorders
Anaemia
|
12.5%
1/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
14.3%
1/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
25.0%
2/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
0.00%
0/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
12.5%
1/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
0.00%
0/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Cardiac disorders
Atrial fibrillation
|
12.5%
1/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
14.3%
1/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Infections and infestations
Pneumonia klebsiella
|
12.5%
1/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
0.00%
0/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Infections and infestations
Septic shock
|
12.5%
1/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
14.3%
1/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
14.3%
1/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Infections and infestations
Urinary tract infection fungal
|
12.5%
1/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
0.00%
0/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Metabolism and nutrition disorders
Hypocholesterolaemia
|
12.5%
1/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
0.00%
0/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.5%
1/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
14.3%
1/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
12.5%
1/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
0.00%
0/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
14.3%
1/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
14.3%
1/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
14.3%
1/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
0.00%
0/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Nervous system disorders
Neurological symptom
|
12.5%
1/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
0.00%
0/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Renal and urinary disorders
Ketonuria
|
12.5%
1/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
0.00%
0/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Renal and urinary disorders
Proteinuria
|
12.5%
1/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
0.00%
0/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
14.3%
1/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
14.3%
1/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
12.5%
1/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
0.00%
0/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
14.3%
1/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
12.5%
1/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
14.3%
1/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
28.6%
2/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
|
Vascular disorders
Hypotension
|
12.5%
1/8 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
14.3%
1/7 • From the date of informed consent through 60 days after the last dose of study drug, up to approximately 75 days
8 participants were enrolled in the placebo group. However, 1 participant met an exclusion criterion and did not receive the IP. Therefore, 7 participants were included in the analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place