A Triple Combination Antiviral Coronavirus Therapy (TriACT) for COVID-19

Covid19 Clinical Trial

— TriACT  

Official title:

A Triple Combination Antiviral Coronavirus Therapy (TriACT) RCT Comparing Nitazoxanide, Ribavirin and Hydroxychloroquine vs. Placebo

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04605588
• Other study ID #: Pro2020001862
• Status: Terminated
• Phase: Phase 2
• Start date: December 2, 2020
• Est. completion date: February 4, 2021

Study information

• Verified date: May 2022
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: February 4, 2021
• Est. primary completion date: January 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• Nitazoxanide
Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)
• Placebo Nitazoxanide
Placebo 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)
• Placebo Ribavirin
Placebo 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 Hydroxychloroquine
Placebo Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)

Locations

Country	Name	City	State
United States	Robert Wood Johnson Medical School	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	SynaVir

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Decline in Viral Load Over the 10 Days After Randomization	qPCR measured via nasal swab	10 days after randomization