Title
A Triple Combination Antiviral Coronavirus Therapy (TriACT) for COVID-19
A Triple Combination Antiviral Coronavirus Therapy (TriACT) RCT Comparing Nitazoxanide, Ribavirin and Hydroxychloroquine vs. Placebo
Phase
Phase 2Lead Sponsor
Rutgers UniversityStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
SARS-CoV Infection Covid19Intervention/Treatment
Nitazoxanide Placebo Nitazoxanide Ribavirin Placebo Ribavirin Hydroxychloroquine Placebo HydroxychloroquineStudy Participants
7New 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.
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.
Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)
Placebo 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)
Placebo 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)
Placebo Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)
5 day dosing of Nitazoxanide, Ribavirin & Hydroxychloroquine sulfate
5 day dosing of placebo
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
| Event Type | Organ System | Event Term |
|---|
qPCR measured via nasal swab
