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Efficacy and Safety Study of Nitazoxanide (NTX) in the Treatment of Patients With SARS-CoV-2 Virus Infection (COVID-19)

NCT04463264 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2020-10-08

No results posted yet for this study

Summary

Evaluation of the efficacy and safety of NTX in adult patients (≥18 years and \<60 years), with SARS-CoV-2 infection with mild symptoms of COVID-19, compared to a placebo control arm. 135 patients will be randomized to either Nitazoxanide (n=90) or placebo (n=45) (2:1). Simple blind design. Primary endpoint: eradication of virus from patients' respiratory tract secretions by the 7th day of treatment.

Conditions

Interventions

DRUG

Nitazoxanide

NTX (500 mg every 6 hours for 14 days) orally with food (P.O.).

DRUG

Placebo

Placebo (1 tablet every 6 hours for 14 days) orally with food (P.O.).

Sponsors & Collaborators

  • Laboratorios Roemmers S.A.I.C.F.

    lead INDUSTRY

Principal Investigators

  • Marcelo Silva, MD · Austral University, Argentina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-26
Primary Completion
2020-11-15
Completion
2020-12-26

Countries

  • Argentina

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04463264 on ClinicalTrials.gov