A Phase 2/3 Randomized and Placebo-Controlled Study of ANA001 in Moderate and Severe COVID-19 Patients

Rank et al., NCT04603924, NCT04603924

Aug 2024

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RCT 46 moderate to severe hospitalized COVID-19 patients showing shorter time to discharge and WHO clinical scale improvement with niclosamide, but no significant difference for resolution of all symptoms and viral clearance.

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 death, 36.2% lower, RR 0.64, p = 0.67, treatment 2 of 23 (8.7%), control 3 of 22 (13.6%), NNT 20.

recovery time, 70.2% lower, relative time 0.30, p = 0.97, treatment mean 4.15 (±4.87) n=23, control mean 13.91 (±1220) n=23, time to 2 point improvement.

recovery time, 6.2% higher, relative time 1.06, p = 0.90, treatment mean 17.0 (±33.0) n=23, control mean 16.0 (±15.9) n=23, time to resolution of symptoms.

time to discharge, 56.7% lower, relative time 0.43, p = 0.98, treatment mean 6.03 (±14.5) n=23, control mean 13.92 (±1220) n=23.

time to viral-, 0.1% lower, relative time 1.00, p = 1.00, treatment mean 13.09 (±29.6) n=23, control mean 13.1 (±14.8) n=23.

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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.

Rank et al., 6 Aug 2024, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 1 author, trial NCT04603924 (history).

This Paper Niclosamide All

Late treatment
is less effective

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