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Study Ref. studied treatmentcontrol treatmentpatientsstudy risk of biassample sizes Results

COVID 19 outpatients meta-analysis

BCN PEP-CoV-2-Research group (Mitja et al. Clin Infect Dis), 2020
 
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
BCN PEP-CoV-2-Study 2 (Mitja Lancet), 2020
 
NCT04304053
RCThydroxychloroquinestandard of careCOVID 19 outpatientssome concern
142/165 inconclusive
    COMIHY, 2020
     
    NCT04340544
    RCThydroxychloroquinestandard of careCOVID 19 outpatientsNA
    -/- inconclusive
      COVID-PEP Severity (Skipper), 2020
       
      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), 2020
         
        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)
        PATCH-cohort 1, 2020
         
        NCT04329923
        RCThydroxychloroquinecontrolCOVID 19 outpatientsNA
        -/- inconclusive
          Q-PROTECT -HCQ alone, 2020
           
          NCT04349592
          RCThydroxychloroquineplaceboCOVID 19 outpatientsNA
          152/152 inconclusive
          • inconclusive 5 % increase in PCR-negative conversion,PCR-negative conversion (7-day) (PE)

          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).