A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19
et al., NEJM, June 3 2020, doi:10.1056/NEJMoa2016638, Jun 2020
HCQ for COVID-19
1st treatment shown to reduce risk in
March 2020, now with p < 0.00000000001 from 424 studies, used in 59 countries.
No treatment is 100% effective. Protocols
combine treatments.
6,200+ studies for
200+ treatments. c19early.org
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Remote post-exposure prophylaxis RCT reporting that "[HCQ] did not prevent illness compatible with Covid-19 or confirmed infection when used as postexposure prophylaxis within 4 days after exposure".
However, this statement is incorrect - cases were reduced, just without statistical significance - it's not possible to conclude there was no efficacy. Additionally, treatment was not within 4 days - there was up to 68 hours shipping delay as below.
COVID-19 cases were reduced by [49%, 29%, 16%] respectively when taken within ~[70, 94, 118] hours of exposure (including shipping delay). The treatment delay-response relationship is significant at p=0.002. For more detailed analysis, see8.
See also:9.
Authors compare with treatment with folic acid. Kaur et al. note that folic acid is predicted to bind to multiple SARS-CoV-2 proteins, folic acid levels are lower in COVID-19 patients with severe disease, folic acid supplementation may help with COVID-19 associated hypertension and hyperhomocystinemia, and differences in a folic acid-related enzyme could impact COVID-19 geographical severity variation.
Time of dosing was not recorded in these trials:11. See12, and Pullen et al.13, which shows shipping delay for these trials of 19 - 68 hours. With enrollment up to 4 days from exposure, this implies delivery 19 - 164 hours after exposure.
Standard of Care (SOC) for COVID-19 in the study country,
the USA, is very poor with very low average efficacy for approved treatments14.
Only expensive, high-profit treatments were approved for early treatment. Low-cost treatments were excluded, reducing the probability of early treatment due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments.
|
risk of case, 17.0% lower, RR 0.83, p = 0.35, treatment 49 of 414 (11.8%), control 58 of 407 (14.3%), NNT 41.
|
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risk of case, 25.1% lower, RR 0.75, p = 0.22, treatment 32 of 414 (7.7%), control 42 of 407 (10.3%), NNT 39, probable COVID-19 cases.
|
| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
4.
researchgate.net, www.researchgate.net/publication/344369617_Hydroxychloroquine_as_Post-Exposure_Prophylaxis_for_Covid-19_Why_simple_data_analysis_can_lead_to_the_wrong_conclusions_from_well-designed_studies.
5.
blog.philbirnbaum.com, blog.philbirnbaum.com/2020/08/the-nejm-hydroxychloroquine-study-fails.html.
6.
longdom.org, www.longdom.org/open-access/hydroxychloroquine-and-interferons-for-the-prophylaxis-and-early-treatment-of-covid19current-clinical-advances.pdf.
Boulware et al., 3 Jun 2020, Randomized Controlled Trial, USA, peer-reviewed, 24 authors, study period 17 March, 2020 - 6 May, 2020, this trial compares with another treatment - results may be better when compared to placebo.
A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19
New England Journal of Medicine, doi:10.1056/nejmoa2016638
BACKGROUND Coronavirus disease 2019 (Covid-19) occurs after exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). For persons who are exposed, the standard of care is observation and quarantine. Whether hydroxychloroquine can prevent symptomatic infection after SARS-CoV-2 exposure is unknown.
METHODS We conducted a randomized, double-blind, placebo-controlled trial across the United States and parts of Canada testing hydroxychloroquine as postexposure prophylaxis. We enrolled adults who had household or occupational exposure to someone with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure). Within 4 days after exposure, we randomly assigned participants to receive either placebo or hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 additional days). The primary outcome was the incidence of either laboratory-confirmed Covid-19 or illness compatible with Covid-19 within 14 days.
RESULTS We enrolled 821 asymptomatic participants. Overall, 87.6% of the participants (719 of 821) reported a high-risk exposure to a confirmed Covid-19 contact. The incidence of new illness compatible with Covid-19 did not differ significantly between participants receiving hydroxychloroquine (49 of 414 [11.8%]) and those receiving placebo (58 of 407 [14.3%]); the absolute difference was −2.4 percentage points (95% confidence interval, −7.0 to 2.2; P = 0.35). Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported.
CONCLUSIONS After high-risk or moderate-risk exposure to Covid-19, hydroxychloroquine did not prevent illness compatible with Covid-19 or confirmed infection when used as postexposure prophylaxis within 4 days after exposure. (Funded by David Baszucki and Jan Ellison Baszucki and others; ClinicalTrials.gov number, NCT04308668.
n engl j med nejm.org
8 T h e ne w e ngl a nd jou r na l o f m e dicine exposure prophylaxis would be effective in highrisk populations is a separate question, with trials ongoing. In order to end the pandemic, a reduction in community transmission is needed. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. A data sharing statement provided by the authors is available with the full text of this article at NEJM.org. We thank the participants who consented to participate in this randomized trial; the members of the data and safety monitoring board (Drs. George Thompson III, Andrej Spec, Tom Chiller, and Bozena Morawski) for their thoughtful, generous service; and Drs. Jakub Tolar, Alexis Turgeon, Brad Benson, Tim Schacker, and Peter Igarashi for institutional support. Dr. Boulware thanks Drs. Paul Bohjanen and Ed Janoff for their mentorship. * Values are through day 5, the date of the scheduled completion of the trial intervention. More than one side effect could occur. Ongoing side effects were reported by approximately 3% of the participants in the hydroxychloroquine group at days 10 and 14 and by less than 1% of those in the placebo group. There was no association between the occurrence of side effects and the incidence of Covid-19. Among participants in whom Covid-19 developed, 30.0% (30 of 100) reported a side effect, as compared with 28.2% (169 of 600) reporting a side effect in whom Covid-19 did not develop (P =..
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