Trial Outcomes & Findings for TXA and Corona Virus 2019 (COVID19) in Outpatients (NCT NCT04338074)

NCT ID: NCT04338074

Last Updated: 2021-05-13

Results Overview

Participant admission to hospital for COVID-19 treatment

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: Randomization to 7 days after randomization
• Results posted on: 2021-05-13

Participant Flow

Participant milestones

Measure	Tranexamic Acid Treatment Tranexamic acid tablets: Oral dosing of 1300 mg p.o. three times per day x 5 days versus identical placebos	Placebo Treatment Placebo oral tablet: 2 tablets p.o. three times per day x 5 days
Overall Study STARTED	3	2
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TXA and Corona Virus 2019 (COVID19) in Outpatients

Baseline characteristics by cohort

Measure	Tranexamic Acid Treatment n=3 Participants Tranexamic acid tablets: Oral dosing of 1300 mg p.o. three times per day x 5 days versus identical placebos	Placebo Treatment n=2 Participants Placebo oral tablet: 2 tablets p.o. three times per day x 5 days	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	38 years n=5 Participants	37 years n=7 Participants	38 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Randomization to 7 days after randomization

Population: Categorical data - admitted to hospital or not

Participant admission to hospital for COVID-19 treatment

Outcome measures

Measure	Tranexamic Acid Treatment n=3 Participants Tranexamic acid tablets: Oral dosing of 1300 mg p.o. three times per day x 5 days versus identical placebos	Placebo Treatment n=2 Participants Placebo oral tablet: 2 tablets p.o. three times per day x 5 days
Hospitalization	0 Participants	0 Participants

Adverse Events

Tranexamic Acid Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Timothy J Ness

University of Alabama at Birmingham

Phone: 205-975-9643

Email: tness@uabmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place