Status:
TERMINATED
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)
Lead Sponsor:
Romark Laboratories L.C.
Conditions:
COVID-19
Viral Respiratory Illnesses
Eligibility:
All Genders
55-120 years
Phase:
PHASE3
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.
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT04343248
Start Date
May 12 2020
End Date
February 1 2021
Last Update
July 8 2024
Active Locations (4)
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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