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Trial to Evaluate Nitazoxanide for Treatment of Mild or Moderate COVID-19 in Subjects at High Risk of Severe Illness

NCT05157243 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2024-09-24

No results posted yet for this study

Summary

The purpose of this study is to determine whether nitazoxanide (NTZ) is safe and effective in treating mild or moderate COVID-19 illness in adults and adolescents at highest risk for severe outcomes. Each participant will be followed for approximately 28 days.

Conditions

Interventions

DRUG

Nitazoxanide

Two NTZ 300 mg extended release tablets administered orally with food twice daily for 5 days

DIETARY_SUPPLEMENT

Vitamin Super-B Complex

Vitamin Super B-Complex administered orally twice daily for 5 days to maintain the blind

DRUG

Placebo

Two matching placebo tablets administered orally with food twice daily for 5 days

OTHER

Standard of Care

Local standard of care for COVID-19

Sponsors & Collaborators

  • Romark Laboratories L.C.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2025-05-31
Completion
2025-05-31
FDA Drug
Yes

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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 NCT05157243 on ClinicalTrials.gov