Objectives
To compare the effectiveness, defined as the ratio of events in the intervention group to the ratio of events in the control group, the use of hydroxychloroquine compared to placebo to prevent progression to severe pneumonia of pregnant women with non‐severe SARS‐CoV2 infection.
Methods
Multicentre, randomised, double‐blind, randomised, placebo‐controlled, 1:1 allocation clinical trial to determine the efficacy of low‐dose hydroxychloroquine in preventing severe pneumonia in pregnant women infected with SARS‐CoV2. The intervention will consist of low doses of hydroxychloroquine (Plaquenil) 200mg tablets every 24 hours for 15 days, with a follow‐up of 21 days after inclusion in the study. Inclusion criteria will consist of pregnant women older than 18 years of any gestational, with positive SARS‐CoV2 infection by PCR testing, and a normal electrocardiogram. The primary outcome as the proportion of severe pneumonia (defined by the American Thoracic Society Criteria) will be evaluated between the control group and the experimental group using relative risk (RR) and absolute risk increase (ARI) in the established period of time plus their respective 95% confidence intervals. (95% CI).
Results
We hypothesize that pregnant women with non‐severe COVID‐19 taking hdroxychloroquine will have an 8% lower risk for progression to severe pneumonia compared to those taking placebo.
Conclusions
This study will provide crucial information on the effectiveness of hydroxychloroquine for the prevention of severe COVID‐19 pneumonia, and if proven effective, the information of this study will help save the lives of these pregnant women by preventing a severe form of the disease.
Supporting information can be found in the online version of this abstract
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Supplementary Materials
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