Effective post-exposure prophylaxis of Covid-19 is associated with use of hydroxychloroquine: Prospective re-analysis of a public dataset incorporating novel data
Wiseman et al., Effective post-exposure prophylaxis of Covid-19 is associated with use of hydroxychloroquine: Prospective.., medRxiv, doi:10.1101/2020.11.29.20235218 (Preprint) (meta analysis)
6th independent analysis showing efficacy from the Boulware PEP trial. This prospective analysis corrects an error in the NEJM paper where shipping delays are omitted (still not corrected).42% reduction in COVID-19 (9.6% vs. 16.5%), RR 0.58 [0.35 - 0.97], p=0.044, for the original trial 3 day specification.Currently there are 9 HCQ post-exposure prophylaxis studies and meta analysis shows:
Abstract: medRxiv preprint doi: https://doi.org/10.1101/2020.11.29.20235218; this version posted July 5, 2021. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
It is made available under a CC-BY-NC-ND 4.0 International license .
Effective post-exposure prophylaxis of Covid-19 associated with hydroxychloroquine: Prospective dataset reanalysis incorporating novel, missing data
Running Title: Postexposure hydroxychloroquine Covid-19 prophylaxis: Reanalysis, missing data
David M. Wiseman, PhD, MRPharmS;a Pierre Kory, MD, MPA;b Samir A Saidi, PhD, MB ChB;c Dan Mazzucco,
PhD.d
a Synechion,
b Aurora
Inc., Dallas, TX, USA
St. Luke’s Medical Center, Milwaukee, WI, USA. and Front Line Critical Care Alliance.
pierrekory@icloud.com
c Central
d
Clinic School, University of Sydney, Australia, sam.saidi@sydney.edu.au
Third Eye Associates, Cherry Hill, NJ, USA. dmazzucco@zsxmedical.com
Address for correspondence:
Dr. David Wiseman, Synechion, Inc., 18208 Preston Road, Suite D9-405, Dallas, 75252
synechion@aol.com
Telephone: 972 931 5596
Fax: 972 931 5476
Word count: 3989 words
Funding source: None
ORCID
DMW
0000-0002-8367-6158
PK
0000-0002-0816-9682
SAS
0000-0001-5165-2461
DM
0000-0003-3578-4610
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medRxiv preprint doi: https://doi.org/10.1101/2020.11.29.20235218; this version posted July 5, 2021. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
It is made available under a CC-BY-NC-ND 4.0 International license .
Abstract
BACKGROUND: A key trial (NCT04308668) of post-exposure prophylaxis found hydroxychloroquine-associated
(HCQ) reductions of Covid-19 by 17% overall and 31% to 49% in subgroups. To understand these trends, we reanalyzed the dataset.
METHODS: Our protocol conformed to the Standard Protocol Items: Recommendations for Interventional Trials
(SPIRIT). We compared the incidence of Covid-19 after HCQ or placebo, stratifying by intervention lag, age, and
gender.
RESULTS: Newly requested data missing from the dataset revealed that 52% and 19% of subjects received
medication 1-2 days after intended and assumed overnight delivery or four-day intervention lag respectively. After
re-analysis, we found reduced HCQ-associated incidence of Covid-19 with Early (up to 3 days post-exposure) (RR
0.58, 95%CI 0.35 - 0.97; p=0.044; NNT 14.5) but not Late (RR 1.22, 95%CI 0.72 - 2.04) prophylaxis.
We found a significant HCQ-associated Covid-19 reduction in subjects 18 to 45 years old with Early (RR 0.54,
95%CI 0.29-0.97; p=0.0448, NNT 11.5) but not Late (RR 1.02, 95%CI 0.55-1.89) prophylaxis, attenuated in older
subjects (RR 0.75, 95%CI 0-27-2.05) and by co-morbidities. Although, we did not detect effects of gender, folate,
zinc, or ascorbate, confounding effects cannot be excluded.
CONCLUSIONS: Using novel data and prospective re-analysis, hydroxychloroquine, in an age-dependent manner,
was associated with reduced Covid-19 compatible illness when supplied for post-exposure prophylaxis between 1
and 3 days after high- or moderate-risk exposure, at higher loading and..
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