NCT04605588

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

December 2, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2021

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2021

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 5, 2022

Completed
Last Updated

May 5, 2022

Status Verified

May 1, 2022

Enrollment Period

2 months

First QC Date

October 26, 2020

Results QC Date

April 6, 2022

Last Update Submit

May 3, 2022

Conditions

SARS-CoV InfectionCovid19

Outcome Measures

Primary Outcomes (1)

  • Rate of Decline in Viral Load Over the 10 Days After Randomization

    qPCR measured via nasal swab

    10 days after randomization

Study Arms (2)

Active Study Drug

ACTIVE COMPARATOR

5 day dosing of Nitazoxanide, Ribavirin \& Hydroxychloroquine sulfate

Drug: NitazoxanideDrug: RibavirinDrug: Hydroxychloroquine

Placebo

PLACEBO COMPARATOR

5 day dosing of placebo

Drug: Placebo NitazoxanideDrug: Placebo RibavirinDrug: Placebo Hydroxychloroquine

Interventions

NitazoxanideDRUG

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

Active Study Drug
Placebo NitazoxanideDRUG

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

Placebo
RibavirinDRUG

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

Active Study Drug
Placebo RibavirinDRUG

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

Placebo
HydroxychloroquineDRUG

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

Active Study Drug
Placebo HydroxychloroquineDRUG

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

Placebo

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Severe Acute Respiratory SyndromeCOVID-19

Interventions

nitazoxanideRibavirinHydroxychloroquine

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPneumonia, ViralPneumoniaLung Diseases

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Jeffrey L Carson, MD
Organization
Rutgers, The State University of New Jersey
Jeffrey.Carson@Rutgers.edu
732-235-7122

Study Officials

  • Jeffrey L Carson, MD

    Rutgers, The State University of New Jersey

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Study medication will be tablets/capsules containing either active drug or placebo
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor of Medicine, Robert Wood Johnson Medical School

Study Record Dates

First Submitted

October 26, 2020

First Posted

October 28, 2020

Study Start

December 2, 2020

Primary Completion

January 17, 2021

Study Completion

February 4, 2021

Last Updated

May 5, 2022

Results First Posted

May 5, 2022

Record last verified: 2022-05

Locations

US(1)