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Trial to Evaluate Nitazoxanide for Treatment of Mild COVID-19 in Subjects Not at High Risk of Severe Illness | Clinical Trials | Clareo Health

WITHDRAWNPHASE3

Trial to Evaluate Nitazoxanide for Treatment of Mild COVID-19 in Subjects Not at High Risk of Severe Illness

Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild COVID-19 in Subjects Not at High Risk of Severe Illness

NCT05157269•Romark Laboratories L.C.

View on ClinicalTrials.gov

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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female at least 12 years of age
•Positive test for SARS-CoV-2 by RT-PCR or validated rapid antigen test within 72 hours prior to enrollment in the trial (positive sample must be collected within 72 hours prior to enrollment).
•Presence of clinical signs and/or symptoms consistent with worsening or stable mild COVID-19 (one of the following is required):
•1. Presence of at least two respiratory symptom domains (head, throat, nose, chest, cough) with a score of ≥2 as determined by Screening FLU-PRO AND
•2. Patient reported assessment that symptoms are present, the symptoms are not consistent with the subject's usual health, the symptoms interfere with daily activities, and the symptoms have worsened or remained the same relative to the previous day, as confirmed by responses to questions in the Screening FLU-PRO.
•Onset of symptoms no more than 72 hours before enrollment in the trial. Onset of symptoms is defined as the earlier of the first time at which the subject experienced subjective fever or any respiratory symptom (headache/head congestion, throat symptoms, nasal symptoms, chest symptoms, cough).
•Willing and able to provide written informed consent (including assent by legal guardian if under 18 years of age) and comply with the requirements of the protocol, including completion of the subject diary and all protocol procedures.

Exclusion Criteria

•Persons with any clinical sign or symptoms suggestive of moderate or severe systemic illness with COVID-19, including the following:
•1. shortness of breath at rest,
•2. resting pulse ≥90 beats per minute,
•3. resting respiratory rate ≥20 breaths per minute, or
•4. oxygen saturation ≤ 93% on room air at sea level.
•Persons who have not been fully vaccinated against SARS-CoV-2 and are at high risk of progressing to severe COVID-19 illness due to having one of the following underlying conditions and/or sociodemographic risk factors:
•1. Age ≥ 55 years (with or without comorbidities),
•2. Body mass index (BMI) ≥30 kg/m² if ≥ 18 years of age or BMI ≥85th percentile for age and gender based on CDC growth charts,
•3. Chronic kidney disease,
•4. Diabetes,
+17 more criteria

Key Dates

Start Date

August 1, 2024

Primary Completion Date

March 1, 2025

Completion Date

March 1, 2025

Last Updated

September 24, 2024

Conditions

COVID-19

Interventions

Nitazoxanide

DRUG

Placebo

DRUG

Vitamin Super-B Complex

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 24, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Trial to Evaluate Nitazoxanide for Treatment of Mild COVID-19 in Subjects Not at High Risk of Severe Illness

Inclusion Criteria

Exclusion Criteria

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