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

COVID 19 outpatients meta-analysis

BLAZE-1 phase 3 (combo)
  NCT04427501		 RCTbamlanivimab/etesevimabplaceboCOVID 19 outpatientssome concern
518/517 suggested
  • suggested 71 % decrease in hospitalization or death (PE) with a moderate degree of certainty due to some concern in risk of bias
  • suggested 95 % decrease in deaths with a moderate degree of certainty due to some concern in risk of bias
COMET-ICE
  NCT04545060		 RCTsotrovimab (Xevudy; VIR-7831)placeboCOVID 19 outpatientslow
528/529 conclusif
  • demonstrated 79 % decrease in hospitalization or death (PE) with a high degree of certainty due to low risk of bias
  • suggested 76 % decrease in clinical deterioration with a high degree of certainty due to low risk of bias
  • suggested 80 % decrease in hospitalization with a high degree of certainty due to low risk of bias
Analysis of final Day 29 data from COMET-ICE confirms sotrovimab significantly reduces hospitalisation and risk of death in adults with mild-to-moderate COVID-19 who are at high risk of progression to severe disease (press release)
BLAZE-1 phase 2 (combination with etesevimab)
  NCT04427501		 RCTbamlanivimab/etesevimabplaceboCOVID 19 outpatientssome concern
112/156 inconclusive
    decreased SARS-CoV-2 log viral load at day 11 compared with placebo of –0.57 [95% CI, –1.00 to –0.14], P = .01
    BLAZE-1 phase 2 (monotherapy)
          NCT04427501    		 RCTbamlanivimab monotherapyplaceboCOVID 19 outpatientssome concern
    		101/156 inconclusive
      no significant difference in viral load reduction was observed for bamlanivimab monotherapy at any dose
      7 studies excluded by filtering options (6 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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