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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)
CT-P59 3.2 part 1
  NCT04602000		 RCTregdanvimab (Regkirona- CT-P59-Celltrion)placeboCOVID 19 outpatientsNA
226/111 inconclusive
    CT-P59 3.2 part 2
          NCT04602000    		 RCTregdanvimab (Regkirona- CT-P59-Celltrion)placeboCOVID 19 outpatientsNA
    		656/659 conclusif
    • demonstrated 71 % decrease in hospitalization or death (PE)
    • suggested 50 % increase in clinical improvement (time to event analysis only),Recovery (time to event analysis only)
    OPTIMISE-C19 (bamlanivimab-etesevimab vs casirivimab-imdevimab)
          NCT04790786    		 RCTbamlanivimab/etesevimabcasirivimab/imdevimab (Ronapreve)COVID 19 outpatientshigh
    		-/- inconclusive
      86% probability of equivalence between bamlanivimab-etesevimab and casirivimab-imdevimab at an odds ratio bound of 0.25
      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
          ACTIV-2 (BRII-196 and BRII-198) unpublished
                      NCT04518410          		 RCTamubarvimab/romlusevimab (BRII-196 and BRII-198-Brii Biosciences)placeboCOVID 19 outpatientsNA
          		418/419 suggested
          • suggested 95 % decrease in deaths
          • suggested 78 % decrease in hospitalization or death
          BLAZE-4 unpublished
                      NCT04634409          		 RCTbamlanivimab/etesevimabplaceboCOVID 19 outpatientsNA
          		158/153 safety concern
          • statistically significant 63 % decrease in viral clearance by day 7
          TACKLE unpublished
                      NCT04723394          		 RCTcilgavimab and tixagevimab (Evusheld)placeboCOVID 19 outpatientsNA
          		452/451 conclusif
          • demonstrated 53 % decrease in hospitalization or death (PE)
          1 study excluded by filtering options (0 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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