Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses in Elderly Residents of Long-Term Care Facilities (LTCF)

COVID-19 Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses in Elderly Residents of Long-Term Care Facilities (LTCF)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04343248
• Other study ID #: RM08-3006
• Status: Terminated
• Phase: Phase 3
• Start date: May 12, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2022
• Source: Romark Laboratories L.C.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF residents.

Description:

Multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF residents.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 190
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 120 Years

Eligibility

Inclusion Criteria:

• Male and female residents of LTCFs at least 55 years of age.

• Willing and able to provide written informed consent and comply with the requirements of the protocol.

• At least one symptomatic laboratory-confirmed COVID-19 illness identified among residents or staff of the LTCF within 10 days prior to randomization.

Exclusion Criteria:

• Alzheimer's disease, dementia, or other mental incapacity which precludes comprehension of the study requirements or symptom diary.

• Subjects expected to require hospitalization within the 8-week treatment and follow-up period.

• Subjects with a history of COVID-19 or known to have developed anti-SARS- CoV-2 antibodies.

• Subjects who experienced a previous episode of acute upper respiratory tract infection, otitis, bronchitis or sinusitis or received antibiotics for these conditions or antiviral therapy for influenza within two weeks prior to and including study day 1.

• Receipt of any dose of NTZ within 7 days prior to screening.

• Treatment with any investigational drug or vaccine within 30 days prior to screening or unwilling to avoid them during the course of the study.

• Known sensitivity to NTZ or any of the excipients comprising the study medication.

• Subjects unable to swallow oral tablets or capsules.

• Subjects taking medications considered to be major CYP2C8 substrates.

• Subjects who, in the judgment of the Investigator, will be unlikely to comply with the requirements of this protocol.

Related Conditions & MeSH terms

• COVID-19
• Viral Respiratory Illnesses

Intervention

Drug:
• Nitazoxanide
Nitazoxanide 600 mg administered orally twice daily for six weeks
• Placebo
Placebo administered orally twice daily for six weeks

Dietary Supplement:
• Vitamin Super B-Complex
Vitamin Super B-Complex administered orally twice daily to maintain the blind

Locations

Country	Name	City	State
United States	Clinical Trial Specialists, Inc.	Acworth	Georgia
United States	Centex Studies, Inc.	Houston	Texas
United States	The Chappel Group Research	Kissimmee	Florida
United States	Centex Studies, Inc.	Lake Charles	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Romark Laboratories L.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptomatic laboratory-confirmed COVID-19	The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the 6-week treatment period.	up to 6 weeks
Primary	Symptomatic laboratory-confirmed VRI	The proportion of subjects with symptomatic laboratory-confirmed VRI identified after the start of treatment and before the end of the 6-week treatment period.	up to 6 weeks