Nitazoxanide superiority to placebo to treat moderate COVID-19 – A Pilot prove of concept randomized double-blind clinical trial

1/22 Late treatment study

Blum et al., EClinicalMedicine, doi:10.1016/j.eclinm.2021.100981 (preprint 1/22) (Peer Reviewed)
Nitazoxanide superiority to placebo to treat moderate COVID-19 – A Pilot prove of concept randomized double-blind clinical trial

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RCT with 25 nitazoxanide patients and 25 control patients, showing improved virological and clinical outcomes with treatment.

Authors also perform an in vitro study in Vero E6 cells showing 90% inhibition with 0.5µM, with no cytotoxicity. NCT04348409.

Blum et al., 1/22/2021, Double Blind Randomized Controlled Trial, Brazil, South America, peer-reviewed, 17 authors.

risk of death, 66.7% lower, RR 0.33, p = 0.25, treatment 2 of 25 (8.0%), control 6 of 25 (24.0%).

risk of mechanical ventilation, 62.5% lower, RR 0.38, p = 0.17, treatment 3 of 25 (12.0%), control 8 of 25 (32.0%).

relative severity scores, 20.2% lower, RR 0.80, treatment 25, control 25.

hospitalization time, 55.7% lower, relative time 0.44, p = 0.02, treatment 25, control 25.

risk of no virological cure, 89.8% lower, RR 0.10, p = 0.03, treatment 0 of 23 (0.0%), control 4 of 19 (21.1%), continuity correction due to zero event (with reciprocal of the contrasting arm), day 21.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. For an individual study the most serious outcome may have a smaller number of events and lower statistical signficance, however this provides the strongest evidence for the most serious outcomes when combining the results of many trials.

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