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

COVID 19 outpatients meta-analysis

COPE – Coalition V
  NCT04466540		 RCThydroxychloroquineplaceboCOVID 19 outpatientssome concern
689/683 inconclusive
  • inconclusive 23 % decrease in hospitalization (PE) with a moderate degree of certainty due to some concern in risk of bias
PATCH Cohort 1 (Amaravadi)
  NCT04329923		 RCThydroxychloroquinestandard of careCOVID 19 outpatientssome concern
15/13 inconclusive
    BCN PEP-CoV-2-Study 2 (Mitja et al. Clin Infect Dis)
          NCT04304053    		 RCThydroxychloroquinestandard of careCOVID 19 outpatientssome concern
    		137/157 safety concern
    • statistically significant 25.5-fold increase in adverse events with a moderate degree of certainty due to some concern in risk of bias
    • statistically significant 177.2-fold increase in adverse events with a moderate degree of certainty due to some concern in risk of bias
    COVID-PEP Severity (Skipper)
          NCT04308668    		 RCThydroxychloroquinecontrolCOVID 19 outpatientssome concern
    		244/247 no results
      change in symptom severity over 14 days did not differ between the hydroxychloroquine and placebo groups (difference in symptom severity: relative, 12%; absolute, −0.27 points [95% CI, −0.61 to 0.07 points]; P = 0.117)
      COVID-PEP Severity (Skipper)
              NCT04308668      		 RCThydroxychloroquineplaceboCOVID 19 outpatientssome concern
      		244/247 safety concern
      • statistically significant 1.8-fold increase in adverse events with a moderate degree of certainty due to some concern in risk of bias
      change in symptom severity over 14 days did not differ between the hydroxychloroquine and placebo groups (difference in symptom severity: relative, 12%; absolute, −0.27 points [95% CI, −0.61 to 0.07 points]; P = 0.117)
      3 studies excluded by filtering options (2 RCT / 1 OBS)

      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).

       

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