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RCT sample size
Nitazoxanide, a broad-spectrum antiparasitic, has been proposed as a possible COVID-19 therapeutic.
Nitazoxanide shows anti-SARS-CoV-2 activity in Vero E6 cells (EC50 = 2.12 μM; CC50 > 35.53 μM; SI > 16.76) and has broad activity against a range of viruses. However, activity in Vero cells does not appear sufficient to establish efficacy in vivo, as hydroxychloroquine/chloroquine have strong anti-SARS-CoV-2 activity in Vero cells but its efficacy is not well established in vivo, perhaps due to differences in TMPRSS2 expression.
Nitazoxanide may also "[potentiate] the production of type 1 interferons (alpha and beta) produced by the host’s fibroblasts," a possible mechanism of benefit in COVID-19.
On October 23, 2020 a randomized, placebo-controlled trial of nitazoxanide in Brazil reported results:
In patients with mild Covid-19, symptom resolution did not differ between the nitazoxanide and placebo groups after 5 days of therapy. However, early nitazoxanide therapy was safe and reduced viral load significantly. --Early use of nitazoxanide in mild Covid-19 disease: randomized, placebo-controlled trial
Critiques of this trial include this twitter thread by Cardiologist Marcio S Bittencourt and that the drug may have been underdosed.
List of clinical trials for nitazoxanide.
On October 23, 2020 a randomized, placebo-controlled trial of nitazoxanide in Brazil reported results (n=500):
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