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

Primary Purpose

SARS-CoV Infection, Covid19

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nitazoxanide
Placebo Nitazoxanide
Ribavirin
Placebo Ribavirin
Hydroxychloroquine
Placebo Hydroxychloroquine
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS-CoV Infection

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Robert Wood Johnson Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active Study Drug

Placebo

Arm Description

5 day dosing of Nitazoxanide, Ribavirin & Hydroxychloroquine sulfate

5 day dosing of placebo

Outcomes

Primary Outcome Measures

Rate of Decline in Viral Load Over the 10 Days After Randomization
qPCR measured via nasal swab

Secondary Outcome Measures

Full Information

First Posted
October 26, 2020
Last Updated
May 3, 2022
Sponsor
Rutgers, The State University of New Jersey
Collaborators
SynaVir
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1. Study Identification

Unique Protocol Identification Number
NCT04605588
Brief Title
A Triple Combination Antiviral Coronavirus Therapy (TriACT) for COVID-19
Acronym
TriACT
Official Title
A Triple Combination Antiviral Coronavirus Therapy (TriACT) RCT Comparing Nitazoxanide, Ribavirin and Hydroxychloroquine vs. Placebo
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of participants willing to enroll
Study Start Date
December 2, 2020 (Actual)
Primary Completion Date
January 17, 2021 (Actual)
Study Completion Date
February 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
SynaVir

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV Infection, Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Study medication will be tablets/capsules containing either active drug or placebo
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Study Drug
Arm Type
Active Comparator
Arm Description
5 day dosing of Nitazoxanide, Ribavirin & Hydroxychloroquine sulfate
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
5 day dosing of placebo
Intervention Type
Drug
Intervention Name(s)
Nitazoxanide
Intervention Description
Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)
Intervention Type
Drug
Intervention Name(s)
Placebo Nitazoxanide
Intervention Description
Placebo Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)
Intervention Type
Drug
Intervention Name(s)
Placebo Ribavirin
Intervention Description
Placebo Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)
Intervention Type
Drug
Intervention Name(s)
Placebo Hydroxychloroquine
Intervention Description
Placebo Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)
Primary Outcome Measure Information:
Title
Rate of Decline in Viral Load Over the 10 Days After Randomization
Description
qPCR measured via nasal swab
Time Frame
10 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey L Carson, MD
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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