Trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF residents.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
190
Nitazoxanide 600 mg administered orally twice daily for six weeks
Placebo administered orally twice daily for six weeks
Vitamin Super B-Complex administered orally twice daily to maintain the blind
The Chappel Group Research
Kissimmee, Florida, United States
Clinical Trial Specialists, Inc.
Acworth, Georgia, United States
Centex Studies, Inc.
Lake Charles, Louisiana, United States
Centex Studies, Inc.
Houston, Texas, United States
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. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
Time frame: up to 6 weeks
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. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
Time frame: up to 6 weeks
Hospitalization Due to COVID-19 or Complications Thereof
Proportion of subjects hospitalized due to COVID-19 or complications thereof. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations
Time frame: Up to 6 weeks
Mortality Due to COVID-19 or Complications Thereof
Proportion of subjects experiencing mortality due to COVID-19 or complications thereof. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
Time frame: Up to 6 weeks
Presence of Anti-SARS-CoV-2 at Weeks 6 or 8
Proportion of subjects with anti-SARS-CoV-2 antibodies at Week 6 or 8 visits. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
Time frame: Up to 8 weeks
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