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

NCT ID: NCT04605588

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-02
• Study Completion Date: 2021-02-04

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.

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.

Conditions

SARS-CoV Infection; Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active Study Drug

5 day dosing of Nitazoxanide, Ribavirin \& Hydroxychloroquine sulfate

Group Type: ACTIVE_COMPARATOR

Nitazoxanide

Intervention Type: DRUG

Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)

Ribavirin

Intervention Type: DRUG

Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)

Hydroxychloroquine

Intervention Type: DRUG

Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)

Placebo

5 day dosing of placebo

Group Type: PLACEBO_COMPARATOR

Placebo Nitazoxanide

Intervention Type: DRUG

Placebo Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)

Placebo Ribavirin

Intervention Type: DRUG

Placebo Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)

Placebo Hydroxychloroquine

Intervention Type: DRUG

Placebo Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)

Interventions

Nitazoxanide

Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)

Intervention Type: DRUG

Placebo Nitazoxanide

Placebo Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)

Intervention Type: DRUG

Ribavirin

Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)

Intervention Type: DRUG

Placebo Ribavirin

Placebo Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)

Intervention Type: DRUG

Hydroxychloroquine

Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)

Intervention Type: DRUG

Placebo Hydroxychloroquine

Placebo Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SynaVir

INDUSTRY

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey L Carson, MD

Distinguished Professor of Medicine, Robert Wood Johnson Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey L Carson, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro2020001862

Identifier Type: -

Identifier Source: org_study_id