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Study Ref. Design studied treatmentcontrol treatmentpatientsstudy risk of biassample sizes Results

COVID-19 prophylaxis (excluding children) meta-analysis

BCN PEP-CoV-2-Study 1 (Mitja NEJM)
 
NCT04304053
RCThydroxychloroquinestandard of careCOVID-19 prophylaxis (excluding children)some concern
1116/1198 safety concern
  • inconclusive 14 % decrease in infection (PCR positive symptomatic or not) (PE) with a moderate degree of certainty due to some concern in risk of bias
  • statistically significant 19.3-fold increase in adverse events with a moderate degree of certainty due to some concern in risk of bias

PE: primary endpoint; (a): to be demonstrated a result must be statistically significant on a primary endpoint (with multiplicity adjustment if necessary);
Study risk of bias assessed for the study primary endpoint(s) or the main endpoints in case of no formally defined primary endpoint(s).