Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection

Romark, NCT04359680, NCT04359680

Jun 2024

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RCT 1,407 healthcare workers and others at high risk of SARS-CoV-2 exposure, showing no difference in COVID-19 cases (13 in each group). There was lower symptom severity for nitazoxanide and a trend towards shorter illness duration. There is no publication, results are only available on clinicaltrials.gov, posted 3 years after completion (FDA pre-notice of noncompliance1).

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risk of progression, 43.5% lower, RR 0.57, p = 0.02, treatment mean 1.3 (±0.95) n=13, control mean 2.3 (±1.11) n=13.

time to perform usual activities, 50.3% lower, RR 0.50, p = 0.10, treatment mean 8.2 (±11.73) n=13, control mean 16.5 (±12.72) n=13.

time to usual health, 32.3% lower, RR 0.68, p = 0.32, treatment mean 13.2 (±16.88) n=13, control mean 19.5 (±14.58) n=13.

acute respiratory illness time, 27.5% lower, RR 0.72, p = 0.49, treatment mean 10.0 (±15.52) n=13, control mean 13.8 (±12.05) n=13.

risk of case, 2.5% lower, RR 0.97, p = 1.00, treatment 13 of 629 (2.1%), control 13 of 613 (2.1%), NNT 1854.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

1. fda.gov, www.fda.gov/media/172470/download?attachment.www.fda.gov/media/172470/download?attachment.

Romark et al., 26 Jun 2024, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 1 author, trial NCT04359680 (history).

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