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NCT04343248 · ClinicalTrials.gov registry record · Phase 3

Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses in Elderly Residents of Long-Term Care Facilities (LTCF)

A Phase 3 study, sponsored by Romark Laboratories L.C..

Terminated
Registry status
Phase 3
Development phase
190
Enrollment target

NCT04343248: Clinical Trial Phase 3 study, sponsored by Romark Laboratories L.C..

NCT04343248 is a Phase 3 study that was terminated before completion, run by Romark Laboratories L.C.. The registered enrollment target is 190 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04343248, a Phase 3 study, was terminated before completion, sponsored by Romark Laboratories L.C..

TERMINATED
Registry status
Phase 3
Development phase
190 participants
Enrollment target

Study Summary

Trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF residents.

Primary Outcome

The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the 6-week treatment period. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.

Interventions

  • DRUG Placebo
  • DRUG Nitazoxanide
  • DIETARY_SUPPLEMENT Vitamin Super B-Complex

Trial Details

FieldValue
Enrollment Target 190 participants
Start Date 2020-05-12
Est. Completion 2021-02-01
Phase Phase 3
Romark Laboratories L.C.

16 total trials

Why NCT04343248 stopped before completion

NCT04343248 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT04343248 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04343248 about?

NCT04343248 is a clinical study titled "Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses in Elderly Residents of Long-Term Care Facilities (LTCF)". Trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF residents.

What is the current status of trial NCT04343248?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 190 participants. The study started on 2020-05-12. Estimated completion is 2021-02-01.

What interventions are being tested in trial NCT04343248?

The interventions under investigation include: Placebo (DRUG), Nitazoxanide (DRUG), Vitamin Super B-Complex (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT04343248?

This trial is sponsored by Romark Laboratories L.C., which has 16 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04343248's enrollment target sits among peer trials

190 1402nd of 2000 higher than 593 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04343248, the US trial registry maintained by the National Library of Medicine. NCT04343248 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.