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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
Must not have
Known sensitivity to nitazoxanide (NTZ) or any of the excipients comprising the study medication.
- Subjects using steroids as maintenance therapy for a chronic condition.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21 days
Awards & highlights

Summary

This trial is testing nitazoxanide, a medication, to see if it can treat colds caused by enterovirus or rhinovirus. The drug works by stopping the viruses from growing, which may help reduce cold symptoms. Nitazoxanide is a broad-spectrum antiviral agent originally developed as an antiprotozoal agent and later repurposed for treating influenza and other viral respiratory infections.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic to nitazoxanide or its ingredients.
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I use steroids regularly for a long-term health issue.
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I am currently receiving chemotherapy or radiotherapy for cancer.
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I am currently taking medication that affects my liver enzyme CYP2C8.
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I experience shortness of breath even when I am resting.
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I show signs of severe illness from COVID-19.
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I am on immunosuppressive therapy or have an immunologic disorder.
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I have not taken nitazoxanide in the last week.
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I had a recent respiratory infection or took antibiotics for it within the last two weeks.
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I cannot swallow pills.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time from First Dose to Sustained Response
Secondary study objectives
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Nitazoxanide, a broad-spectrum antiviral agent, works by inhibiting viral protein synthesis, which is crucial for the replication and survival of viruses, including Enteroviruses. This mechanism of action is significant for Enterovirus patients because it directly targets the virus's ability to reproduce and spread within the host, thereby reducing the viral load and alleviating symptoms. By disrupting the viral life cycle, Nitazoxanide can potentially shorten the duration of the illness and prevent complications associated with Enterovirus infections.
The Combination of Venetoclax and Ixazomib Selectively and Efficiently Kills HIV-Infected Cell Lines but Has Unacceptable Toxicity in Primary Cell Models.Human DEAD-box protein 3 has multiple functions in gene regulation and cell cycle control and is a prime target for viral manipulation.

Find a Location

Who is running the clinical trial?

Romark Laboratories L.C.Lead Sponsor
28 Previous Clinical Trials
9,407 Total Patients Enrolled
1 Trials studying Enterovirus
1,756 Patients Enrolled for Enterovirus
~81 spots leftby May 2025