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NCT04486313 · ClinicalTrials.gov registry record · Phase 3
Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19
A Phase 3 study of COVID-19, sponsored by Romark Laboratories L.C..
- Completed
- Registry status
- Phase 3
- Development phase
- 935
- Enrollment target
- 2
- Study locations
NCT04486313: Completed Phase 3 study of COVID-19, sponsored by Romark Laboratories L.C..
NCT04486313 is a Phase 3 study of COVID-19 that has completed, run by Romark Laboratories L.C.. The registered enrollment target is 935 participants, below the 38,462-participant average among 298 other COVID-19 trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04486313, a Phase 3 study of COVID-19, has completed, sponsored by Romark Laboratories L.C..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 935 participants
- Enrollment target
- 2
- Study locations
Study Summary
Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19
Primary Outcome
Time to Sustained Clinical Recovery is the time in days from the first dose of study medication to the first time at which the subject reports a decrease in total FLU-PRO score from the previous diary with assessment that symptoms are at least "somewhat better than yesterday", no oral temperature ≥100.4 F in the prior 24 hours, and no future increase in any of the FLU-PRO domains except within validated background levels.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Nitazoxanide
- DIETARY_SUPPLEMENT Vitamin Super B-Complex
Study Locations (2)
Florida
- Invesclinic US LLC - Fort Lauderdale
New York
- RH Medical Urgent Care - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 935 participants |
| Start Date | 2020-08-13 |
| Est. Completion | 2021-02-08 |
| Phase | Phase 3 |
What the finished NCT04486313 record still lists
NCT04486313 is an interventional study that assigns participants to a tested intervention. The registered 935 participants enrollment target is mid-sized for trials with a published cap, below the 38,462-participant average among 298 other COVID-19 trials with a reported enrollment target (98% lower).
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04486313 reports a single indexed study location in Florida, New York.
Frequently Asked Questions
What is clinical trial NCT04486313 about?
NCT04486313 is a clinical study titled "Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19". Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19
What is the current status of trial NCT04486313?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 935 participants. The study started on 2020-08-13. Estimated completion is 2021-02-08.
What conditions does trial NCT04486313 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT04486313?
The interventions under investigation include: Placebo (DRUG), Nitazoxanide (DRUG), Vitamin Super B-Complex (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04486313?
This trial is sponsored by Romark Laboratories L.C., which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04486313 being conducted?
This trial has 2 study locations across Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for COVID-19
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04486313's enrollment target sits among peer trials
935 82nd of 298 higher than 217 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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