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Antiparasitic

Nitazoxanide for Common Cold

Phase 3

Recruiting

Research Sponsored by Romark Laboratories L.C.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 21 days

Awards & highlights

Study Summary

This trial tests a drug to see if it can safely and effectively treat colds caused by viruses.

Who is the study for?

This trial is for outpatients aged 12 and above with a common cold due to enterovirus/rhinovirus, experiencing two or more respiratory symptoms. They must be able to consent and follow the study plan. Excluded are those with recent respiratory infections, severe immunodeficiency, pregnancy without birth control use, current severe illness including COVID-19, or taking certain medications.Check my eligibility

What is being tested?

The trial tests Nitazoxanide's effectiveness in treating colds caused by enterovirus/rhinovirus compared to a placebo. Participants will also receive Vitamin Super B-Complex. The goal is to see if Nitazoxanide helps reduce the severity of cold symptoms safely.See study design

What are the potential side effects?

Nitazoxanide may cause stomach pain, nausea, vomiting, headache or dizziness; however side effects vary from person to person. No specific side effects are listed for the Vitamin Super B-Complex.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have symptoms like a worsening or stable cold due to a virus.

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I have severe respiratory symptoms and my pulse rate is 90 or higher.

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I have at least two severe respiratory symptoms.

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My symptoms started less than 3 days ago.

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I have severe respiratory symptoms with a breathing rate of 16 or more.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~21 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time from First Dose to Sustained Response

Secondary outcome measures

Proportion of Subjects Requiring Systemic Antibiotics

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: NitazoxanideActive Control2 Interventions

Two nitazoxanide 300 mg tablets orally twice daily for 5 days

Group II: PlaceboPlacebo Group2 Interventions

Two placebo tablets orally twice daily for 5 days

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Romark Laboratories L.C.Lead Sponsor

28 Previous Clinical Trials

12,007 Total Patients Enrolled

1 Trials studying Enterovirus

1,756 Patients Enrolled for Enterovirus

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you provide a detailed overview of Nitazoxanide's safety profile?

"Nitazoxanide is deemed relatively safe, having been assigned a score of 3 due to the available clinical data and prior studies demonstrating its efficacy."

Answered by AI

Is the recruitment stage of this trial still open?

"Affirmative. According to the clinicaltrials.gov listing, this medical study commenced on May 13th 2020 and is currently open for recruitment. 800 patients need to be enrolled across 3 distinct sites in order for the trial to reach completion."

Answered by AI

What is the scale of enrollment to this research endeavor?

"Romark Laboratories L.C., the sponsor of this trial, require 800 participants that meet specific inclusion criteria to begin running this study at RH Medical Urgent Care in Bronx, New york and HealthStar Research LLC in Hot Springs, Arkansas among other sites."

Answered by AI

Is the research open to individuals aged 45 or older?

"According to the trial specifications, individuals between 12 and 120 years old may be eligible for this medical study. Additionally, there are 5 separate trials available for those under 18-years-old and 6 more that cater to people over 65."

Answered by AI

Am I eligible to take part in this research endeavor?

"This clinical trial seeks 800 outpatients aged 12 to 120 that have a confirmed case of enterovirus. To be considered, participants must meet one or more of the following criteria: male/female patients with at least two respiratory symptom domains (head, throat, nose, chest, cough) scoring ≥2 on screening FLU-PRO; pulse rate ≥90 and presence of any single respiratory symptom domain (as mentioned above); OR respiration rate ≥16 combined with subject's self assessment indicating that symptoms are abnormal for them and diminished daily activities due to said condition within 72 hours prior enrollment. Additionally these individuals must willingly provide informed consent along"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04489381.

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