What side effects are associated with this type of intervention?

Nitazoxanide, an antiviral that inhibits viral protein synthesis, is being studied for its efficacy against Enterovirus infections. Common side effects of Nitazoxanide include gastrointestinal symptoms such as nausea, vomiting, and abdominal pain. Other potential side effects are headache and dizziness. These side effects are generally mild to moderate in severity.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Enterovirus that focus on the inhibition of viral protein synthesis similar to Nitazoxanide. Nitazoxanide itself is an antiviral that has shown efficacy in treating various viral infections by inhibiting viral protein synthesis, but its use for Enterovirus is still under investigation. Broadly, treatment for Enterovirus infections is generally supportive, focusing on symptom management rather than specific antiviral therapies.

What other types of research exist?

Promising novel alternatives to Nitazoxanide for Enterovirus treatment include monoclonal antibodies targeting specific viral proteins, such as those used to prevent malaria and other viral infections. Additionally, new antiviral drugs like Bedaquiline-Pretomanid-Linezolid regimens, which have shown efficacy in treating drug-resistant infections, may offer potential. Further research and clinical trials are needed to confirm their effectiveness specifically for Enterovirus.

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Antiparasitic

Nitazoxanide for Common Cold

Phase 3

Waitlist Available

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

All Individual Drugs Already Approved

Pivotal Trial

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 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

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 15Eligibility criteria met

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.