Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection

NCT04489381 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: RM08-3009
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 3

Brief Summary

Trial to evaluate the efficacy and safety of nitazoxanide in the treatment of colds due to enterovirus/rhinovirus infection

Conditions

Enterovirus; Rhinovirus

Keywords

Enterovirus; Rhinovirus

Outcome Measures

Primary Outcomes (1)

• Time From First Dose to Sustained Response

  Time to Sustained Response 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. NOTE: Data collection ended at study day 21 and \>25% of subjects in each treatment group had not yet achieved Sustained Response (32% in the Nitazoxanide group and 35% in the Placebo group). Therefore, it was impossible to calculate a third quartile for either group. Data presented here imputes "21" as the third quartile. No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.

  21 days

Secondary Outcomes (1)

• Proportion of Subjects Requiring Systemic Antibiotics

  21 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 cold due to Enterovirus/Rhinovirus infection (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:

• 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 viruses (HIV) infection or treated human immunodeficiency viruses (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 a chronic condition.
• Subjects with active respiratory allergies or subjects expected to require anti- allergy medications during the study period for respiratory allergies.
• 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.
• Receipt of any dose of nitazoxanide (NTZ) within seven days prior to screening.
• Known sensitivity to nitazoxanide (NTZ) or any of the excipients comprising the study medication.
• Subjects unable to swallow oral tablets or capsules.
• Subjects with known severe heart, lung, neurological or other systemic disease that the Investigator believes could preclude safe participation.
• Subjects likely or expected to require hospitalization unrelated to cold during the study period.
• Subjects who, in the judgment of the Investigator, will be unlikely to comply with the requirements of this protocol including completion of the subject diary.

Sponsors & Collaborators

• Romark Laboratories L.C.: lead

Study Sites (3)

HealthStar Research LLC

Hot Springs, Arkansas, 71913, United States

Location

Invesclinic US LLC

Fort Lauderdale, Florida, 33308, United States

Location

RH Medical Urgent Care

The Bronx, New York, 10456, United States

Location

MeSH Terms

Conditions

Enterovirus Infections

Interventions

nitazoxanide

Condition Hierarchy (Ancestors)

Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Limitations and Caveats

Enrollment was paused due to the COVID-19 pandemic in early 2021 with intention of resuming enrollment at a later date. Ultimately, the study was terminated prior to reaching the enrollment goal. Fewer than half of the planned number of patients were enrolled. Study results are summarized descriptively, but no statistical analyses were performed due to sample size insufficient for statistical comparison.

Results Point of Contact

• Title: Jessica Fulgencio
• Organization: Romark, L.C.

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 28, 2020
• Study Start: August 19, 2020
• Primary Completion: January 28, 2021
• Study Completion: February 2, 2021
• Last Updated: October 17, 2024
• Results First Posted: October 17, 2024

Record last verified: 2024-10

Locations

US (3)