A Triple Combination Antiviral Coronavirus Therapy (TriACT) for COVID-19
Stopped early · Phase 2 · Has a placebo group
Conditions studied: SARS-CoV Infection, Covid19
In brief
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.
Key facts
- Study ID
- NCT04605588
- Run by
- Rutgers, The State University of New Jersey
- People needed
- 7
- Starts
- 2020-12-02
- Expected to finish
- 2021-02-04
- Last updated by the study team
- 2022-05-05
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Documented SARS-CoV-2 infection by qPCR assay performed within the past 7 days
You may not qualify if…
- 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
Where it is running
- Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
Full record on ClinicalTrials.gov
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