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0 0.5 1 1.5 2+ Hospitalization 50% Improvement Relative Risk Case 27% c19hcq.org Rajasingham et al. NCT04328467 HCQ RCT PrEP Favors HCQ Favors control
Hydroxychloroquine as pre-exposure prophylaxis for COVID-19 in healthcare workers: a randomized trial
21 Sep 2020    Source   PDF   Share   Tweet
PrEP RCT showing HR 0.73, p = 0.12. Trial halted after 47% enrollment, p < 0.05 will be reached at ~75% enrollment if similar results continue.
HR 0.66/0.68 for full medication adherence, 0.72/0.74, p = 0.18/0.22 overall (1x/2x dosing). Efficacy for first responders was higher, OR 0.32, p = 0.01. First responders had a much higher incidence, allowing greater power, and reducing the effect of confounders such as misdiagnosis of other conditions or survey issues.
Performance is similar to placebo for the first 3 weeks. The effect may be greater with a dosage regimen that achieves therapeutic levels faster [tandfonline.com]. ~40% of participants suspected they might have had COVID-19 before the trial, the effect in people without prior COVID-19 may be higher.
Authors note:
- the trial was underpowered
- investigation into more frequent dosing may be warranted
- insufficient dosing with no participants achieving more than the in vitro EC50
Internet survey RCT subject to survey bias. There were no deaths or ICU admissions. Low risk healthcare workers, median age ~40. 494 1x/week dosing, 495 2x/week dosing, 494 control participants (1x and 2x participants received the same overall dosage). COVID PREP. NCT04328467 (history).
risk of hospitalization, 50.1% lower, RR 0.50, p = 1.00, treatment 1 of 989 (0.1%), control 1 of 494 (0.2%), NNT 987.
risk of case, 27.0% lower, HR 0.73, p = 0.12, treatment 58 of 989 (5.9%), control 39 of 494 (7.9%), NNT 49.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Rajasingham et al., 21 Sep 2020, Randomized Controlled Trial, USA, peer-reviewed, 22 authors, trial NCT04328467 (history).
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