Trial to Evaluate Nitazoxanide for Treatment of Mild COVID-19 in Subjects Not at High Risk of Severe Illness
NCT05157269 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2024-09-24
Summary
The purpose of this study is to determine whether nitazoxanide (NTZ) is safe and effective for treatment of mild COVID-19 illness. Adults and adolescent participants 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
- DRUG
-
Two matching placebo tablets administered orally twice daily for 5 days
- DIETARY_SUPPLEMENT
-
Vitamin Super-B Complex
Vitamin Super-B Complex administered orally with food twice daily for 5 days to maintain the blind
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
- 2025-03-31
- Completion
- 2025-03-31
- FDA Drug
- Yes
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