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

NCT03605862 | Completed Phase 3 Results FDA Drug

• 1 other identifier: RM08-3005
• Study Type: interventional
• Target: 1,756
• Locations: 2 countries
• Sites: 45

Brief Summary

Trial to evaluate 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 Symptom Response Over 21 Days of Follow up Based Upon the FLU-PRO Instrument (Novel Endpoint)

  Subjects used the FLU-PRO questionnaire once daily in the evening to score the severity of 32 FLU-PRO symptoms. Symptom response was deemed achieved when the rating for each of the 32 FLU-PRO symptoms was ≤ its assigned threshold for 2 consecutive daily diary periods without use of symptom relief medication. The symptom response thresholds were developed by applying an algorithm to blinded symptoms data to select the set of 32 symptom thresholds most closely associated with patient-reported usual health.

  Up to 21 days

Secondary Outcomes (2)

• Time From First Dose to Ability to Perform All Normal Activities

  Up to 21 days

• Proportions Experiencing Complications of EV/RV Infection

  28 days

Other Outcomes (4)

• Time to Return to Usual Health

  21 days

• Proportion Positive for EV/RV by RT-PCR at Days 2, 3 and 7

  Days 2, 3, and 7

• Analysis of Change From Baseline to Days 2, 3 and 7 in EV/RV Virus Titer

  Days 2, 3, and 7

Study Arms (2)

Nitazoxanide

ACTIVE COMPARATOR

Two Nitazoxanide 300 mg tablets orally twice daily for 5 days

Drug: Nitazoxanide

Placebo

PLACEBO COMPARATOR

Two placebo tablets orally twice daily for 5 days

Drug: Placebo

Interventions

Nitazoxanide DRUG

Nitazoxanide 600 mg administered orally twice daily for five days

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

Nitazoxanide

Placebo DRUG

Placebo administered orally twice daily for five days

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 and female subjects at least 12 years of age
• Presence of clinical signs and/or symptoms consistent with an acute illness compatible with EV/RV infection (each of the following is required):
• Presence of moderate or severe rhinorrhea defined as "attempting to relieve nasal symptoms by blowing, wiping, or sniffling at least twice per hour for any one hour within 12 hours preceding study entry," AND
• Presence of cough, sore throat or nasal obstruction.
• Negative rapid influenza diagnostic test (required only if the subject has an oral temperature \>100°F in the clinic or if the latest CDC weekly influenza report shows influenza prevalence "Regional" or higher for the institution's state). A result from a rapid influenza diagnostic test performed on the same day that informed consent is obtained will be sufficient to meet this criterion if documentation of test results is available as part of medical history.
• Onset of illness no more than 40 hours before enrollment in the trial. Onset of illness is defined as the first time at which the subject experienced rhinorrhea, cough, sore throat or nasal obstruction.
• 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

You may not qualify if:

• Persons requiring or anticipated to require in-hospital care
• Cystic fibrosis
• Cardiac arrhythmia
• Immunologic disorders or receiving immunosuppressive therapy (e.g., for organ or bone marrow transplants, immunomodulatory therapies for certain autoimmune diseases)
• Untreated HIV infection or treated HIV infection with a CD4 count below 350 cells/mm3 in the last 6 months
• Persons with sickle cell anemia or other hemoglobinopathies
• Poorly controlled insulin-dependent diabetes mellitus (HbA1C \>8.0%)
• Concurrent infection at the screening examination that requires systemic antimicrobial therapy
• Females who are breastfeeding
• Receipt of any dose of NTZ within 30 days prior to screening
• Prior treatment with any investigational drug therapy within 30 days prior to screening
• Subjects with active respiratory allergies or subjects expected to require anti-allergy medications during the study period for respiratory allergies
• Known sensitivity to NTZ or any of the excipients comprising the NTZ tablets
• Subjects unable to take oral medications
• 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 (45)

Vanguard Study Site

Birmingham, Alabama, 35235, United States

Location

Vanguard Study Site

Birmingham, Alabama, 35242, United States

Location

Vanguard Study Site

Pelham, Alabama, 35124, United States

Location

Vanguard Study Site

Hot Springs, Arkansas, 71913, United States

Location

Vanguard Study Site

Anaheim, California, 92805, United States

Location

Vanguard Study Site

Westminster, California, 92683, United States

Location

Vanguard Study Site

Wilmington, California, 90744, United States

Location

Vanguard Study Site

Miami, Florida, 33145, United States

Location

Vanguard Study Site

Miami, Florida, 33155, United States

Location

Vanguard Study Site

Miami, Florida, 33174, United States

Location

Vanguard Study Site

Orlando, Florida, 32819, United States

Location

Vanguard Study Site

Tampa, Florida, 33609, United States

Location

Vanguard Study Site

Stockbridge, Georgia, 30281, United States

Location

Vanguard Study Site

Blackfoot, Idaho, 83221, United States

Location

Vanguard Study Site

Meridian, Idaho, 83642, United States

Location

Vanguard Study Site

Nampa, Idaho, 83686, United States

Location

Vanguard Study Site

Evanston, Illinois, 60201, United States

Location

Vanguard Study Site

Valparaiso, Indiana, 46383, United States

Location

Vanguard Study Site

Louisville, Kentucky, 40207, United States

Location

Vanguard Study Site

New Orleans, Louisiana, 70115, United States

Location

Vanguard Study Site

New Orleans, Louisiana, 70124, United States

Location

Vanguard Study Site

Baltimore, Maryland, 21236, United States

Location

Vanguard Study Site

St Louis, Missouri, 63141, United States

Location

Vanguard Study Site

Missoula, Montana, 59808, United States

Location

Vanguard Study Site

Bellevue, Nebraska, 68005, United States

Location

Vanguard Study Site

Las Vegas, Nevada, 89104, United States

Location

Vanguard Study Site

Brooklyn, New York, 11229, United States

Location

Vanguard Study Site

Raleigh, North Carolina, 27607, United States

Location

Vanguard Study Site

Cincinnati, Ohio, 45215, United States

Location

Vanguard Study Site

Cleveland, Ohio, 44122, United States

Location

Vanguard Study Site

Columbus, Ohio, 43214, United States

Location

Vanguard Study Site

Dayton, Ohio, 45424, United States

Location

Vanguard Study Site

Medford, Oregon, 97504, United States

Location

Vanguard Study Site

East Providence, Rhode Island, 02914, United States

Location

Vanguard Study Site

Jackson, Tennessee, 38305, United States

Location

Vanguard Study Site

Milan, Tennessee, 38328, United States

Location

Vanguard Study Site

Austin, Texas, 78735, United States

Location

Vanguard Study Site

Carrollton, Texas, 75010, United States

Location

Vanguard Study Site

Houston, Texas, 77058, United States

Location

Vanguard Study Site

McAllen, Texas, 78504, United States

Location

Vanguard Study Site

Plano, Texas, 75024, United States

Location

Vanguard Study Site

Bountiful, Utah, 84010, United States

Location

Vanguard Study Site

St. George, Utah, 84790, United States

Location

Vanguard Study Site

Ponce, 00780, Puerto Rico

Location

Vanguard Study Site

San Juan, 00926, Puerto Rico

Location

MeSH Terms

Conditions

Enterovirus Infections

Interventions

nitazoxanide

Condition Hierarchy (Ancestors)

Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Limitations and Caveats

This study used a novel primary endpoint that was weakly correlated (r=0.43) with the anchor assessment of usual health, resulting in a primary analysis of questionable interpretability. The post-hoc analysis of Time to Sustained Recovery may be a more reliable endpoint given consistency with other endpoints (time to return to usual health, proportions experiencing complications, proportions positive for EV/RV).

Results Point of Contact

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

jessica.fulgencio@romark.com

813-282-8544

Study Officials

• Jean-Francois Rossignol, M.D., Ph.D

  Romark Laboratories L.C.

  STUDY DIRECTOR

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 18, 2018
• First Posted: July 30, 2018
• Study Start: September 11, 2018
• Primary Completion: February 4, 2019
• Study Completion: February 4, 2019
• Last Updated: April 14, 2022
• Results First Posted: April 14, 2022

Record last verified: 2022-04

Locations

PR (2); US (43)