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

NCT05157269 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: RM08-3011
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

COVID-19

Keywords

SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Time to sustained COVID-19 Recovery

  Day 1 through Day 21

Other Outcomes (3)

• Time to return to usual health

  Day 1 through Day 21

• Proportion of participants progressing to severe COVID-19 illness or death by any cause

  Day 1 through Day 28

• Change in cytokine levels

  Day 1 through Day 4

Study Arms (2)

Nitazoxanide

ACTIVE COMPARATOR

Nitazoxanide 300 mg extended release tablets

Drug: Nitazoxanide; Dietary Supplement: Vitamin Super-B Complex

Placebo

PLACEBO COMPARATOR

Placebo tablets

Drug: Placebo; Dietary Supplement: Vitamin Super-B Complex

Interventions

Nitazoxanide DRUG

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

Also known as: NTZ, NT-300

Nitazoxanide

Placebo DRUG

Two matching placebo tablets administered orally twice daily for 5 days

Placebo

Vitamin Super-B Complex DIETARY_SUPPLEMENT

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

Nitazoxanide; Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• 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
• 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.

You may not qualify if:

• Persons with any clinical sign or symptoms suggestive of moderate or severe systemic illness with COVID-19, including the following:
• shortness of breath at rest,
• resting pulse ≥90 beats per minute,
• resting respiratory rate ≥20 breaths per minute, or
• 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:
• Age ≥ 55 years (with or without comorbidities),
• 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,
• Chronic kidney disease,
• Diabetes,
• Cardiovascular disease (including congenital heart disease) or hypertension,
• Chronic lung disease (e.g., chronic obstructive pulmonary disease, moderate-to-severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension),
• Sickle cell disease,
• Neurodevelopmental disorders or other conditions that confer medical complexity.
• Subjects with immunosuppressive disease or receiving immunosuppressive treatment regardless of SARS-CoV-2 vaccination status.

Sponsors & Collaborators

• Romark Laboratories L.C.: lead

MeSH Terms

Conditions

COVID-19

Interventions

nitazoxanide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: December 14, 2021
• Study Start: August 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: September 24, 2024

Record last verified: 2024-09