A Triple Combination Antiviral Coronavirus Therapy (TriACT) for COVID-19
Study Details
Study Description
Brief Summary
New outpatient treatments for COVID-19 are urgently needed. There is some evidence that a combination of three medications currently used to treat other viral infections could be effective in fighting this new virus. The purpose of this trial is to evaluate the efficacy of Nitazoxanide (NTZ), Ribavirin (RBV) and Hydroxychloroquine (HCQ) versus placebo in participants with proven SARS-CoV-2 infection
The study will enroll 70 participants within the 7 days after having been diagnosed with coronavirus infection. The purpose is to determine if those randomized to 5-day dosing with the three medication combination have decreased viral load and severity of illness in the 10 days following treatment as compared to those taking placebo. Participants will be actively followed for 28 days.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
Participants will be randomized into one of two treatment plans
-
Triple combination:
-
Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)
-
Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)
-
Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)
-
No active Medication:
-
Placebo administered according to the above schedule
Viral load (qPCR via nasal swab) will be assessed at baseline (day 0) as well as at days 3, 6, and 10 to monitor response to antiviral treatment. Immune status will be determined by antibody testing of blood collected at baseline and day 28. Symptom questionnaires will be completed daily for 10 days and day 28.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Active Study Drug 5 day dosing of Nitazoxanide, Ribavirin & Hydroxychloroquine sulfate |
Drug: Nitazoxanide
Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)
Drug: Ribavirin
Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)
Drug: Hydroxychloroquine
Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)
|
Placebo Comparator: Placebo 5 day dosing of placebo |
Drug: Placebo Nitazoxanide
Placebo Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)
Drug: Placebo Ribavirin
Placebo Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)
Drug: Placebo Hydroxychloroquine
Placebo Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)
|
Outcome Measures
Primary Outcome Measures
- Rate of Decline in Viral Load Over the 10 Days After Randomization [10 days after randomization]
qPCR measured via nasal swab
Eligibility Criteria
Criteria
Inclusion Criteria:
- Documented SARS-CoV-2 infection by qPCR assay performed within the past 7 days
Exclusion Criteria:
-
COVID-19 symptoms requiring hospitalization
-
PO2 < 92%
-
Short of breath at time of enrollment
-
Retinal eye disease
-
Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency
-
Known chronic kidney disease, stage - 5 or receiving dialysis
-
Current use of:
-
Class 3 AAD (amiodarone, dronaderone, dofetilide, sotalol)
-
Class 1A AAD (procainamide, quinidine, disopyramide)
-
Flecainide
-
SSRI: citalopram (Celexa), Escitalopram (Lexapro)
-
chlorpromazine
-
Cilostazol (Pletal)
-
Donepezil (Aricept)
-
Droperidol
-
Fluoconazole
-
Methadone
-
Ondansetron (Zofran)
-
Thioridazine
-
Macrolides (clarithromycin, erythromycin)
-
Fluroquinolones (ciprofloxacin, levofloxacin, moxifloxacin)
-
Tamoxifen
-
Pregnancy or women who are breast feeding
-
Inability to tolerate oral medications
-
Allergy or prior adverse reaction to either hydroxychloroquine sulfate, ribavirin, or nitazoxanide
-
Allergy to adhesives
-
QTc interval > 450 mSEC for men and women
-
History of Torsade de Pointes VT or prior cardiac arrest or congenital long QT interval
-
Non-English-speaking
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Robert Wood Johnson Medical School | New Brunswick | New Jersey | United States | 08903 |
Sponsors and Collaborators
- Rutgers, The State University of New Jersey
- SynaVir
Investigators
- Principal Investigator: Jeffrey L Carson, MD, Rutgers, The State University of New Jersey
Study Documents (Full-Text)
More Information
Publications
None provided.- Pro2020001862
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Active Study Drug | Placebo |
---|---|---|
Arm/Group Description | 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) | 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) |
Period Title: Overall Study | ||
STARTED | 2 | 5 |
COMPLETED | 1 | 5 |
NOT COMPLETED | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Active Study Drug | Placebo | Total |
---|---|---|---|
Arm/Group Description | 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) | 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 of all reporting groups |
Overall Participants | 2 | 5 | 7 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
38
(2.8)
|
44
(15.0)
|
42
(12.6)
|
Sex: Female, Male (Count of Participants) | |||
Female |
2
100%
|
3
60%
|
5
71.4%
|
Male |
0
0%
|
2
40%
|
2
28.6%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
1
20%
|
1
14.3%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
0
0%
|
0
0%
|
0
0%
|
White |
2
100%
|
4
80%
|
6
85.7%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
Title | Rate of Decline in Viral Load Over the 10 Days After Randomization |
---|---|
Description | qPCR measured via nasal swab |
Time Frame | 10 days after randomization |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Active Study Drug | Placebo |
---|---|---|
Arm/Group Description | 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) | 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) |
Measure Participants | 0 | 0 |
Adverse Events
Time Frame | 28 Days | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Active Study Drug | Placebo | ||
Arm/Group Description | 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) | 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) | ||
All Cause Mortality |
||||
Active Study Drug | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/1 (0%) | 0/5 (0%) | ||
Serious Adverse Events |
||||
Active Study Drug | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/1 (0%) | 0/5 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Active Study Drug | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/1 (0%) | 0/5 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Jeffrey L Carson, MD |
---|---|
Organization | Rutgers, The State University of New Jersey |
Phone | 732-235-7122 |
Jeffrey.Carson@Rutgers.edu |
- Pro2020001862