A 2-Part, 2-Arm, Phase 2, Randomized, Double-Blind, Placebo-Controlled Study on the Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection

First Wave BioPharma, NCT04858425, RESERVOIR, NCT04858425

May 2023

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RCT 118 hospitalized patients with gastrointestinal infection showing no significant difference in viral clearance with niclosamide. Viral clearance results are available on clinicaltrials.gov but clinical results are missing.

Viral load measured by PCR may not accurately reflect infectious virus measured by viral culture. Porter et al. show that viral load early in infection was correlated with infectious virus, but viral load late in infection could be high even with low or undetectable infectious virus. Assessing viral load later in infection may underestimate reductions in infectious virus with treatment.

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risk of no viral clearance, 22.7% lower, RR 0.77, p = 0.61, treatment 8 of 60 (13.3%), control 10 of 58 (17.2%), NNT 26, day 43.

risk of no viral clearance, 33.1% lower, RR 0.67, p = 0.35, treatment 9 of 60 (15.0%), control 13 of 58 (22.4%), NNT 13, day 36.

risk of no viral clearance, 42.0% lower, RR 0.58, p = 0.17, treatment 9 of 60 (15.0%), control 15 of 58 (25.9%), NNT 9.2, day 29.

risk of no viral clearance, 27.5% lower, RR 0.73, p = 0.39, treatment 12 of 60 (20.0%), control 16 of 58 (27.6%), NNT 13, day 22.

risk of no viral clearance, 22.7% lower, RR 0.77, p = 0.34, treatment 20 of 60 (33.3%), control 25 of 58 (43.1%), NNT 10, day 15.

risk of no viral clearance, 0.8% lower, RR 0.99, p = 1.00, treatment 39 of 60 (65.0%), control 38 of 58 (65.5%), NNT 193, day 8.

risk of no viral clearance, 2.6% higher, RR 1.03, p = 0.80, treatment 52 of 60 (86.7%), control 49 of 58 (84.5%), day 4.

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1. Porter et al., The ratio between SARS-CoV-2 RNA viral load and culturable viral titer differs depending on stage of infection, medRxiv, doi:10.1101/2023.07.06.23292300.medrxiv.org, doi.org.

First Wave BioPharma et al., 1 May 2023, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 1 author, trial NCT04858425 (history) (RESERVOIR).

This Paper Niclosamide All

Late treatment
is less effective

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