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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https://c19hcq.org/novartis.html

HCQ for COVID-19

1st treatment shown to reduce risk in March 2020, now with p < 0.00000000001 from 423 studies, used in 59 countries.

Lower risk for mortality, hospitalization, progression, recovery, cases, and viral clearance.

No treatment is 100% effective. Protocols combine treatments.

5,700+ studies for 169 treatments. c19hcq.org

Early terminated RCT with only 20 patients.

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.

Standard of Care (SOC) for COVID-19 in the study country, the USA, is very poor with very low average efficacy for approved treatments2. Only expensive, high-profit treatments were approved. Low-cost treatments were excluded, reducing the probability of treatment—especially early—due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments.

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risk of death, 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 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

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.

2. c19early.org, c19early.org/soc/usa.html.c19early.org/soc/usa.html.

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

This Paper HCQ All

Late treatment
is less effective

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