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)
Primary Purpose
COVID-19, Viral Respiratory Illnesses
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Nitazoxanide
Placebo
Vitamin Super B-Complex
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring COVID-19, Viral Respiratory Illnesses
Eligibility Criteria
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.
Sites / Locations
- The Chappel Group Research
- Clinical Trial Specialists, Inc.
- Centex Studies, Inc.
- Centex Studies, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Nitazoxanide
Placebo
Arm Description
Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks
Two placebo tablets orally twice daily for 6 weeks
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04343248
Brief Title
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)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Study recruitment was halted prematurely as widespread vaccination of the study population made completion infeasible.
Study Start Date
May 12, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Romark Laboratories L.C.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Viral Respiratory Illnesses
Keywords
COVID-19, Viral Respiratory Illnesses
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nitazoxanide
Arm Type
Active Comparator
Arm Description
Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Two placebo tablets orally twice daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Nitazoxanide
Other Intervention Name(s)
NTZ (nitazoxanide), NT-300
Intervention Description
Nitazoxanide 600 mg administered orally twice daily for six weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered orally twice daily for six weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin Super B-Complex
Intervention Description
Vitamin Super B-Complex administered orally twice daily to maintain the blind
Primary Outcome Measure Information:
Title
Symptomatic laboratory-confirmed COVID-19
Description
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.
Time Frame
up to 6 weeks
Title
Symptomatic laboratory-confirmed VRI
Description
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.
Time Frame
up to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
The Chappel Group Research
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34744
Country
United States
Facility Name
Clinical Trial Specialists, Inc.
City
Acworth
State/Province
Georgia
ZIP/Postal Code
30101
Country
United States
Facility Name
Centex Studies, Inc.
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Centex Studies, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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)
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