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

NCT04605588 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2022-05-05

Study results available
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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.

Conditions

  • SARS-CoV Infection
  • Covid19

Interventions

DRUG

Nitazoxanide

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

DRUG

Placebo Nitazoxanide

Placebo 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

Placebo Ribavirin

Placebo 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)

DRUG

Placebo Hydroxychloroquine

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

Sponsors & Collaborators

  • SynaVir

    collaborator INDUSTRY

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Jeffrey L Carson, MD · Rutgers, The State University of New Jersey

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-02
Primary Completion
2021-01-17
Completion
2021-02-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04605588 on ClinicalTrials.gov