Hydroxychloroquine Monotherapy and in Combination With Azithromycin in Patients With Moderate and Severe COVID-19 Disease

Novartis, NCT04358081, NCT04358081

Jul 2020

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Early terminated RCT with only 20 patients.

Viral load measured by PCR may not accurately reflect infectious virus measured by viral culture. Porter 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.

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.

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risk of no hospital discharge, 70.6% lower, RR 0.29, p = 0.42, treatment 0 of 7 (0.0%), control 1 of 5 (20.0%), NNT 5.0, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 15.

risk of no improvement, 70.6% lower, RR 0.29, p = 0.42, treatment 0 of 7 (0.0%), control 1 of 5 (20.0%), NNT 5.0, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), clinical response, day 15.

risk of no viral clearance, 78.6% higher, RR 1.79, p = 0.56, treatment 5 of 7 (71.4%), control 2 of 5 (40.0%), day 10.

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

Novartis et al., 27 Jul 2020, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 1 author, trial NCT04358081 (history).

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Late treatment
is less effective

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