Trial Outcomes & Findings for A Triple Combination Antiviral Coronavirus Therapy (TriACT) for COVID-19 (NCT NCT04605588)
NCT ID: NCT04605588
Last Updated: 2022-05-05
Results Overview
qPCR measured via nasal swab
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
10 days after randomization
Results posted on
2022-05-05
Participant Flow
Participant milestones
| Measure |
Active Study Drug
5 day dosing of Nitazoxanide, Ribavirin \& Hydroxychloroquine sulfate
Nitazoxanide: Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)
Ribavirin: Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)
Hydroxychloroquine: Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)
|
Placebo
5 day dosing of placebo
Placebo Nitazoxanide: Placebo Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)
Placebo Ribavirin: Placebo Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)
Placebo Hydroxychloroquine: Placebo Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
5
|
|
Overall Study
COMPLETED
|
1
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Active Study Drug
5 day dosing of Nitazoxanide, Ribavirin \& Hydroxychloroquine sulfate
Nitazoxanide: Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)
Ribavirin: Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)
Hydroxychloroquine: Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)
|
Placebo
5 day dosing of placebo
Placebo Nitazoxanide: Placebo Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)
Placebo Ribavirin: Placebo Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)
Placebo Hydroxychloroquine: Placebo Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Triple Combination Antiviral Coronavirus Therapy (TriACT) for COVID-19
Baseline characteristics by cohort
| Measure |
Active Study Drug
n=2 Participants
5 day dosing of Nitazoxanide, Ribavirin \& Hydroxychloroquine sulfate
Nitazoxanide: Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)
Ribavirin: Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)
Hydroxychloroquine: Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)
|
Placebo
n=5 Participants
5 day dosing of placebo
Placebo Nitazoxanide: Placebo Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)
Placebo Ribavirin: Placebo Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)
Placebo Hydroxychloroquine: Placebo Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
44 years
STANDARD_DEVIATION 15.0 • n=7 Participants
|
42 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 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
|
1 Participants
n=7 Participants
|
1 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 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
|
PRIMARY outcome
Timeframe: 10 days after randomizationPopulation: This trial was terminated due to lack of enrollment. A total of 7 participants were randomized. Study outcome was to be response to antiviral treatment (rate of decline in viral load over the 10 days after randomization) as measured via nasal swab qPCR analysis. Based on the lack of enrollment, the swab analysis was not performed.
qPCR measured via nasal swab
Outcome measures
Outcome data not reported
Adverse Events
Active Study Drug
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Jeffrey L Carson, MD
Rutgers, The State University of New Jersey
Phone: 732-235-7122
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place