Trial Outcomes & Findings for TXA127 for the Treatment of Severe COVID-19 (NCT NCT04401423)

NCT ID: NCT04401423

Last Updated: 2022-07-27

Results Overview

Calculated from baseline (at enrollment) to end of study

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

Day 1 and Day 10

Results posted on

2022-07-27

Participant Flow

Participant milestones

Participant milestones
Measure	TXA127 Participants received one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). TXA127: 0.5 mg/kg per day	Placebo Participants received one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). Placebo: 0.5 mg/kg per day
Overall Study STARTED	11	11
Overall Study COMPLETED	6	9
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Reasons for withdrawal
Measure	TXA127 Participants received one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). TXA127: 0.5 mg/kg per day	Placebo Participants received one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). Placebo: 0.5 mg/kg per day
Overall Study Withdrawal by Subject	3	1
Overall Study Physician Decision	2	1

Baseline Characteristics

TXA127 for the Treatment of Severe COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TXA127 n=11 Participants Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). TXA127: 0.5 mg/kg per day	Placebo n=9 Participants Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). Placebo: 0.5 mg/kg per day	Total n=20 Participants Total of all reporting groups
Age, Continuous	55 years n=99 Participants	55 years n=107 Participants	55 years n=206 Participants
Sex: Female, Male Female	2 Participants n=99 Participants	5 Participants n=107 Participants	7 Participants n=206 Participants
Sex: Female, Male Male	9 Participants n=99 Participants	4 Participants n=107 Participants	13 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=99 Participants	7 Participants n=107 Participants	15 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Region of Enrollment United States	11 Participants n=99 Participants	9 Participants n=107 Participants	20 Participants n=206 Participants
Oxygen at randomization Room air	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Oxygen at randomization Nasal cannula	7 Participants n=99 Participants	8 Participants n=107 Participants	15 Participants n=206 Participants
Oxygen at randomization High flow nasal cannula	3 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants
Oxygen at randomization Non-invasive ventilation/BiPAP	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants

PRIMARY outcome

Timeframe: Day 1 and Day 10

Population: Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.

Calculated from baseline (at enrollment) to end of study

Outcome measures

Outcome measures
Measure	TXA127 n=11 Participants Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). TXA127: 0.5 mg/kg per day	Placebo n=9 Participants Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). Placebo: 0.5 mg/kg per day
Change of Serum Creatinine	0.92 mg/dL Interval 0.56 to 1.26	0.70 mg/dL Interval 0.45 to 1.11

PRIMARY outcome

Timeframe: From Day 1 to Day 10

Population: Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.

Outcome measures

Outcome measures
Measure	TXA127 n=11 Participants Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). TXA127: 0.5 mg/kg per day	Placebo n=9 Participants Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). Placebo: 0.5 mg/kg per day
Number of Participants Requiring Intubation	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to Day 10

Outcome measures

Outcome measures
Measure	TXA127 n=11 Participants Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). TXA127: 0.5 mg/kg per day	Placebo n=9 Participants Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). Placebo: 0.5 mg/kg per day
Number of Participants Requiring Dialysis	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 10

Outcome measures

Outcome measures
Measure	TXA127 n=11 Participants Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). TXA127: 0.5 mg/kg per day	Placebo n=9 Participants Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). Placebo: 0.5 mg/kg per day
Number of Participants Requiring a Vasopressors	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 1 and Day 10

Outcome measures

Outcome measures
Measure	TXA127 n=11 Participants Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). TXA127: 0.5 mg/kg per day	Placebo n=9 Participants Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). Placebo: 0.5 mg/kg per day
Percent Change in Supplemental Oxygen Requirements	0.71 percent change of oxygen Interval -5.0 to 5.38	0.91 percent change of oxygen Interval -5.05 to 5.68

SECONDARY outcome

Timeframe: Day 1 to Day 10

Outcome measures

Outcome measures
Measure	TXA127 n=11 Participants Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). TXA127: 0.5 mg/kg per day	Placebo n=9 Participants Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). Placebo: 0.5 mg/kg per day
Days of Hospital Stay and Drug Administration Length of Hospital Stay	11 days Interval 6.0 to 21.0	7 days Interval 6.0 to 8.0
Days of Hospital Stay and Drug Administration Days of Drug/placebo administration	4 days Interval 2.5 to 8.5	5 days Interval 4.0 to 6.0

SECONDARY outcome

Timeframe: Day 1

Outcome measures

Outcome measures
Measure	TXA127 n=10 Participants Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). TXA127: 0.5 mg/kg per day	Placebo n=9 Participants Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). Placebo: 0.5 mg/kg per day
Cytokine Levels on the Day of Drug/TXA Administration IL-1Ra	15.9 pg/ml Interval 8.73 to 17.21	7.6 pg/ml Interval 4.48 to 19.19
Cytokine Levels on the Day of Drug/TXA Administration IL-2	0.52 pg/ml Interval 0.19 to 1.17	0.37 pg/ml Interval 0.16 to 0.68
Cytokine Levels on the Day of Drug/TXA Administration IL-4	0.41 pg/ml Interval 0.21 to 0.78	0.21 pg/ml Interval 0.05 to 1.79
Cytokine Levels on the Day of Drug/TXA Administration Interferon-γ	1.44 pg/ml Interval 0.64 to 2.24	1.0 pg/ml Interval 0.59 to 1.32
Cytokine Levels on the Day of Drug/TXA Administration IL-1β	20.7 pg/ml Interval 11.7 to 41.9	30.6 pg/ml Interval 10.9 to 75.3
Cytokine Levels on the Day of Drug/TXA Administration IL-5	1.72 pg/ml Interval 1.02 to 8.2	1.21 pg/ml Interval 0.9 to 1.69
Cytokine Levels on the Day of Drug/TXA Administration IL-6	9.63 pg/ml Interval 5.58 to 51.79	3.35 pg/ml Interval 2.79 to 9.53
Cytokine Levels on the Day of Drug/TXA Administration IL-8	24.4 pg/ml Interval 15.9 to 61.1	16.2 pg/ml Interval 10.3 to 23.34
Cytokine Levels on the Day of Drug/TXA Administration TNF-α	68.4 pg/ml Interval 30.9 to 95.9	45.9 pg/ml Interval 37.16 to 58.7
Cytokine Levels on the Day of Drug/TXA Administration IL-10	12.3 pg/ml Interval 5.4 to 29.6	10.8 pg/ml Interval 1.35 to 25.6
Cytokine Levels on the Day of Drug/TXA Administration IL-12p40	32.4 pg/ml Interval 24.5 to 64.2	28.9 pg/ml Interval 18.1 to 45.4
Cytokine Levels on the Day of Drug/TXA Administration IL-12p70	1.74 pg/ml Interval 0.83 to 2.74	0.63 pg/ml Interval 0.3 to 1.38
Cytokine Levels on the Day of Drug/TXA Administration IL-13	9.9 pg/ml Interval 8.11 to 43.5	8.5 pg/ml Interval 6.49 to 14.2
Cytokine Levels on the Day of Drug/TXA Administration MCP-1	345 pg/ml Interval 248.0 to 479.0	283 pg/ml Interval 219.0 to 351.0

SECONDARY outcome

Timeframe: Day 5

Outcome measures

Outcome measures
Measure	TXA127 n=5 Participants Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). TXA127: 0.5 mg/kg per day	Placebo n=4 Participants Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). Placebo: 0.5 mg/kg per day
Cytokine Levels on the Day 5 of Drug/TXA Administration IL-4	0.09 pg/ml Interval 0.05 to 0.3	0.74 pg/ml Interval 0.44 to 1.04
Cytokine Levels on the Day 5 of Drug/TXA Administration IL-5	3.36 pg/ml Interval 2.34 to 11.74	0.99 pg/ml Interval 0.77 to 2.99
Cytokine Levels on the Day 5 of Drug/TXA Administration IL-6	12.88 pg/ml Interval 5.03 to 33.21	1.34 pg/ml Interval 0.78 to 6.89
Cytokine Levels on the Day 5 of Drug/TXA Administration IL-8	24.5 pg/ml Interval 14.1 to 29.3	14.3 pg/ml Interval 6.5 to 56.82
Cytokine Levels on the Day 5 of Drug/TXA Administration TNF-α	31.1 pg/ml Interval 27.3 to 61.8	42.1 pg/ml Interval 36.2 to 60.4
Cytokine Levels on the Day 5 of Drug/TXA Administration IL-10	2.46 pg/ml Interval 2.03 to 2.75	4.19 pg/ml Interval 1.65 to 6.79
Cytokine Levels on the Day 5 of Drug/TXA Administration IL-12p40	45.40 pg/ml Interval 31.7 to 55.9	29.8 pg/ml Interval 22.1 to 38.9
Cytokine Levels on the Day 5 of Drug/TXA Administration IL-12p70	1.28 pg/ml Interval 0.42 to 1.64	1.21 pg/ml Interval 0.89 to 1.58
Cytokine Levels on the Day 5 of Drug/TXA Administration IL-13	10.71 pg/ml Interval 8.11 to 25.01	11.4 pg/ml Interval 11.1 to 13.9
Cytokine Levels on the Day 5 of Drug/TXA Administration MCP-1	218 pg/ml Interval 191.0 to 317.0	237 pg/ml Interval 179.0 to 264.0
Cytokine Levels on the Day 5 of Drug/TXA Administration Interferon-γ	0.88 pg/ml Interval 0.59 to 1.63	0.78 pg/ml Interval 0.58 to 1.06
Cytokine Levels on the Day 5 of Drug/TXA Administration IL-1β	14.4 pg/ml Interval 6.1 to 27.0	50.6 pg/ml Interval 29.7 to 71.6
Cytokine Levels on the Day 5 of Drug/TXA Administration IL-1Ra	17.77 pg/ml Interval 7.92 to 28.43	7.38 pg/ml Interval 4.18 to 16.78
Cytokine Levels on the Day 5 of Drug/TXA Administration IL-2	0.20 pg/ml Interval 0.12 to 0.48	0.91 pg/ml Interval 0.83 to 4.37

SECONDARY outcome

Timeframe: Day 1 to Day 10

Outcome measures

Outcome measures
Measure	TXA127 n=11 Participants Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). TXA127: 0.5 mg/kg per day	Placebo n=9 Participants Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). Placebo: 0.5 mg/kg per day
Mortality	1 Participants	0 Participants

Adverse Events

TXA127

Serious events: 3 serious events

Other events: 7 other events

Deaths: 2 deaths

Placebo

Serious events: 2 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	TXA127 n=11 participants at risk Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). TXA127: 0.5 mg/kg per day	Placebo n=9 participants at risk Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). Placebo: 0.5 mg/kg per day
Respiratory, thoracic and mediastinal disorders Intubation	27.3% 3/11 • Number of events 3 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.	22.2% 2/9 • Number of events 2 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.

Other adverse events

Additional Information

Dr. Jeanine D'Armiento / Principal Investigator

Columbia University Irving Medical Center

Phone: 212-305-3745

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	TXA127 n=11 participants at risk Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). TXA127: 0.5 mg/kg per day	Placebo n=9 participants at risk Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days). Placebo: 0.5 mg/kg per day
Gastrointestinal disorders Right abdominal side pain	18.2% 2/11 • Number of events 2 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.	0.00% 0/9 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.
General disorders Diaphoresis	0.00% 0/11 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.	11.1% 1/9 • Number of events 1 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.
Respiratory, thoracic and mediastinal disorders Refractory Hypoxemia	9.1% 1/11 • Number of events 1 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.	11.1% 1/9 • Number of events 1 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.
Respiratory, thoracic and mediastinal disorders Pneumothorax	9.1% 1/11 • Number of events 1 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.	0.00% 0/9 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.
Vascular disorders Refractory Hypotension	0.00% 0/11 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.	11.1% 1/9 • Number of events 1 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.
General disorders Headache	18.2% 2/11 • Number of events 2 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.	0.00% 0/9 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.
General disorders Vertigo	0.00% 0/11 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.	11.1% 1/9 • Number of events 1 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.
Gastrointestinal disorders Hematochezia	9.1% 1/11 • Number of events 1 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.	0.00% 0/9 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.
General disorders Nausea	18.2% 2/11 • Number of events 2 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.	0.00% 0/9 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.
General disorders Fatigue	9.1% 1/11 • Number of events 1 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.	0.00% 0/9 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.
Cardiac disorders Tachycardia	9.1% 1/11 • Number of events 1 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.	0.00% 0/9 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.
Skin and subcutaneous tissue disorders Dyshidrotic Dermatitis	9.1% 1/11 • Number of events 1 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.	0.00% 0/9 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.
General disorders Fever	9.1% 1/11 • Number of events 1 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.	0.00% 0/9 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.
Respiratory, thoracic and mediastinal disorders Tussis	9.1% 1/11 • Number of events 1 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.	11.1% 1/9 • Number of events 1 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.
Respiratory, thoracic and mediastinal disorders Angina Pectoris	9.1% 1/11 • Number of events 1 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.	0.00% 0/9 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.
General disorders Cloudiness of Consciousness	9.1% 1/11 • Number of events 1 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.	0.00% 0/9 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.
Musculoskeletal and connective tissue disorders Myalgia	18.2% 2/11 • Number of events 2 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.	22.2% 2/9 • Number of events 2 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.
Musculoskeletal and connective tissue disorders Transient Paresthesia	9.1% 1/11 • Number of events 1 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.	0.00% 0/9 • Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call. Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.