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)

• Sponsor: Romark Laboratories L.C. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04343248
• Collaborator: (none)
• Enrollment: 190
• Locations: 4
• Arms: 2
• Actual Duration (Months): 13.6
• Patients Per Site: 47.5
• Patients Per Site Per Month: 3.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19; Viral Respiratory Illnesses	Drug: Nitazoxanide; Drug: Placebo; Dietary Supplement: Vitamin Super B-Complex	Phase 3

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 190 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• 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)
• Actual Study Start Date: May 12, 2020
• Actual Primary Completion Date: Jun 30, 2021
• Actual Study Completion Date: Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Nitazoxanide Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks	Drug: Nitazoxanide; Nitazoxanide 600 mg administered orally twice daily for six weeks; Other Names: NTZ (nitazoxanide) NT-300 ; Dietary Supplement: Vitamin Super B-Complex; Vitamin Super B-Complex administered orally twice daily to maintain the blind
Placebo Comparator: Placebo Two placebo tablets orally twice daily for 6 weeks	Drug: 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

Outcome Measures

Primary Outcome Measures

1. Symptomatic laboratory-confirmed COVID-19 [up to 6 weeks]

   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.

2. Symptomatic laboratory-confirmed VRI [up to 6 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Chappel Group Research	Kissimmee	Florida	United States	34744
2	Clinical Trial Specialists, Inc.	Acworth	Georgia	United States	30101
3	Centex Studies, Inc.	Lake Charles	Louisiana	United States	70601
4	Centex Studies, Inc.	Houston	Texas	United States	77058

Sponsors and Collaborators

• Romark Laboratories L.C.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Romark Laboratories L.C.
• ClinicalTrials.gov Identifier: NCT04343248
• Other Study ID Numbers: RM08-3006
• First Posted: Apr 13, 2020
• Last Update Posted: Jun 30, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Romark Laboratories L.C.: COVID-19; Viral Respiratory Illnesses
• Additional relevant MeSH terms: COVID-19; Nitazoxanide

Study Results

No Results Posted as of Jun 30, 2022