Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19

NCT04486313 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: RM08-3008
• Study Type: interventional
• Target: 935
• Locations: 1 country
• Sites: 2

Brief Summary

Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Time to Sustained Clinical Recovery

  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.

  Up to 21 days

Secondary Outcomes (1)

• Proportion of Subjects Progressing to Severe COVID-19

  Up to 21 days

Other Outcomes (4)

• Proportion of Subjects Positive for SARS-CoV-2 by Aptima® SARS-CoV-2 Assay at Each of Days 4 and 10

  Day 4 and Day 10

• Change From Baseline in Quantitative SARS-CoV-2 RNA Measured by RT-PCR at Each of Days 4 and 10

  Day 4 and Day 10

• Proportion of Subjects Requiring Hospitalization

  28 days

Study Arms (2)

Nitazoxanide

ACTIVE COMPARATOR

Two nitazoxanide 300 mg tablets orally twice daily for 5 days

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

Placebo

PLACEBO COMPARATOR

Two placebo tablets orally twice daily for 5 days

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

Interventions

Nitazoxanide DRUG

Two nitazoxanide 300 mg tablets administered orally twice daily with food for 5 days

Also known as: NTZ (nitazoxanide), NT-300

Nitazoxanide

Placebo DRUG

Two placebo tablets administered orally twice daily with food for 5 days

Placebo

Vitamin Super B-Complex DIETARY_SUPPLEMENT

Vitamin Super B-Complex administered orally twice daily to maintain the blind

Nitazoxanide; Placebo

Eligibility Criteria

• Age: 12 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female outpatients at least 12 years of age
• Presence of clinical signs and/or symptoms consistent with worsening or stable mild or moderate 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 OR
• Presence of at least one respiratory symptom domain (head, throat, nose, chest, cough) with a score of ≥2 as determined by Screening FLU-PRO with pulse rate ≥90 OR
• Presence of at least one respiratory symptom domain (head, throat, nose, chest, cough) with a score of ≥2 as determined by Screening FLU-PRO with respiratory rate ≥16
• 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 (head, throat, nose, chest, or cough symptoms).
• 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 severe systemic illness with COVID-19, including the following:
• shortness of breath at rest,
• resting pulse ≥125 beats per minute,
• resting respiratory rate ≥30 breaths per minute, or
• SpO2 ≤ 93% on room air at sea level.
• Subjects who experienced a previous episode of acute upper respiratory tract infection, otitis, bronchitis or sinusitis or received antibiotics for these conditions within two weeks prior to and including study day 1.
• Severely immunodeficient persons including:
• Subjects with immunologic disorders or receiving immunosuppressive therapy (e.g., for organ or bone marrow transplants, immunomodulatory therapies for certain autoimmune diseases)
• Subjects with untreated human immunodeficiency virus (HIV) infection or treated human immunodeficiency virus (HIV) infection with a CD4 count below 350 cells/mm3 in the last six months
• Subjects actively undergoing systemic chemotherapy or radiotherapy treatment for malignancy
• Subjects using steroids as maintenance therapy for chronic conditions
• Subjects with active respiratory allergies or subjects expected to require anti- allergy medications during the study period for respiratory allergies.
• Subjects with a history of COVID-19 or known to have developed anti-SARS- CoV-2 antibodies.
• Subjects residing in the same household with another subject participating in the study.
• Treatment with any investigational drug or vaccine therapy within 30 days prior to screening and willing to avoid them during the course of the study.

Sponsors & Collaborators

• Romark Laboratories L.C.: lead

Study Sites (2)

Invesclinic US LLC

Fort Lauderdale, Florida, 33308, United States

Location

RH Medical Urgent Care

The Bronx, New York, 10456, United States

Location

Related Publications (1)

• Rossignol JF, Bardin MC, Fulgencio J, Mogelnicki D, Brechot C. A randomized double-blind placebo-controlled clinical trial of nitazoxanide for treatment of mild or moderate COVID-19. EClinicalMedicine. 2022 Feb 28;45:101310. doi: 10.1016/j.eclinm.2022.101310. eCollection 2022 Mar.

  PMID: 35237748 DERIVED

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

Results Point of Contact

• Title: Sr. Director, Research Operations
• Organization: Romark

jessica.fulgencio@romark.com

8132828544

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 24, 2020
• Study Start: August 13, 2020
• Primary Completion: February 8, 2021
• Study Completion: February 8, 2021
• Last Updated: March 29, 2024
• Results First Posted: March 29, 2024

Record last verified: 2024-03

Locations

US (2)