Study explorer (study characteristics and results) method abbreviations pdf   xlsx

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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), 2021
 
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
Clemency, 2021
 
NCT04377711
RCTciclesonideplaceboCOVID 19 outpatientslow
197/203 inconclusive
    COLCORONA, 2021
     
    NCT04322682
    RCTcolchicineplaceboCOVID 19 outpatientslow
    2235/2253 safety concern
    • inconclusive 21 % decrease in hospitalization or death (PE) with a high degree of certainty due to low risk of bias
    • statistically significant 74 % increase in related AE (TRAE) with a high degree of certainty due to low risk of bias
    COMET-ICE, 2021
     
    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)
    Cov-2069 (Cohort B: positive SARS-CoV-2 RT-qPCR test result), 2021
     
    NCT04452318
    RCTcasirivimab/imdevimab (Ronapreve)placeboCOVID 19 outpatientssome concern
    156/158 conclusif
    • demonstrated 44 % decrease in symptomatic Covid-19 (PE) with a moderate degree of certainty due to some concern in risk of bias
    Ezer N (CONTAIN), 2021
     
    NCT04435795
    RCTciclesonideplaceboCOVID 19 outpatientssome concern
    108/107 inconclusive
    • inconclusive 25 % increase in recovery (PE) with a moderate degree of certainty due to some concern in risk of bias
    Feld, 2021
     
    NCT04354259
    RCTpeginterferonplaceboCOVID 19 outpatientslow
    30/30 conclusif
    • demonstrated 3.1-fold increase in viral clearance by day 7 (PE) with a high degree of certainty due to low risk of bias
    PRINCIPLE, 2021
     
    ISRCTN86534580
    RCTbudesonidestandard of careCOVID 19 outpatientssome concern
    1073/1988 conclusif
    • demonstrated 21 % increase in clinical improvement,recovery (PE) with a moderate degree of certainty due to some concern in risk of bias
    PRINCIPLE (COLCHICINE), 2021
     
    ISRCTN86534580
    RCTcolchicinestandard of careCOVID 19 outpatientssome concern
    212/2081 inconclusive
    • inconclusive 29 % increase in hospitalization or death (PE) with a moderate degree of certainty due to some concern in risk of bias
    • inconclusive 8 % decrease in recovery (PE) with a moderate degree of certainty due to some concern in risk of bias
    BLAZE-1 phase 2 (combination with etesevimab), 2020
     
    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), 2020
       
      NCT04427501
      RCTbamlanivimab monotherapyplaceboCOVID 19 outpatientssome concern
      101/156 inconclusive
        no significant difference in viral load reduction was observed for bamlanivimab monotherapy at any dose
        C3PO, 2020
         
        NCT04355767
        RCTconvalescent plasma treatmentplaceboCOVID 19 outpatientssome concern
        257/254 inconclusive
        • inconclusive 9 % decrease in hospitalization or death (PE) with a moderate degree of certainty due to some concern in risk of bias
        Cov-2067 Weinreich (1200mg) Cohort 1, 2020
         
        NCT04425629
        RCTcasirivimab/imdevimab (Ronapreve)placeboCOVID 19 outpatientssome concern
        838/840 conclusif
        • demonstrated 71 % decrease in hospitalization or death (PE) with a moderate degree of certainty due to some concern in risk of bias
        press release December 2021 : Currently authorized REGEN-COV® (casirivimab and imdevimab) antibodies have diminished potency versus Omicron
        9 studies excluded by filtering options (8 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).