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

COVID-19 prophylaxis (excluding children) meta-analysis

Asano
 
NCT04568031
RCTVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)placeboCOVID-19 prophylaxis (excluding children)NA
-/- inconclusive
    Com-COV2
     
    ISRCTN 27841311
    RCTVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)vaccinesCOVID-19 prophylaxis (excluding children)NA
    -/- inconclusive
      AstraZeneca phase 3 US (D8110C00001)
       
      NCT04516746
      RCTVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)placeboCOVID-19 prophylaxis (excluding children)NA
      21583/10796 safety concern
      • suggested 76 % decrease in symptomatic Covid-19
      • statistically significant 62 % increase in adverse events
      statistically significant vaccine efficacy of 78.9% in preventing symptomatic COVID-19 and 100% efficacy in preventing severe or critical disease and hospitalization. In participants 65 years and older, who comprised 20% of the trial population, vaccine efficacy against symptomatic COVID-19 was 79.9%
      Com-COV
       
      ISRCTN69254139
      RCTVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)Comirnaty (tozinameran - Pfizer/BIONTECH)COVID-19 prophylaxis (excluding children)NA
      -/- inconclusive
        AstraZeneca Oxford pooled analysis (COV003, COV001, COV002, COV005)_safety RCTVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)controlCOVID-19 prophylaxis (excluding children)NA
        12282/11962 inconclusive
          pooled data of four trials are registered at ISRCTN89951424 (COV003) and ClinicalTrials.gov, NCT04324606 (COV001), NCT04400838 (COV002), andNCT04444674 (COV005)
          ChAdOx1 phase 3 (AstraZeneca)
           
          NCT04400838
          RCTVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)controlCOVID-19 prophylaxis (excluding children)some concern
          5807/5829 conclusif
          • demonstrated 67 % decrease in symptomatic Covid-19 (PE) with a moderate degree of certainty due to some concern in risk of bias
          Scotland cohort unpublished OBSVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)controlCOVID-19 prophylaxis (excluding children)NA
          -/- suggested
            EPIPHARE (Vaxzevria) OBSVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)controlCOVID-19 prophylaxis (excluding children)NA
            -/- safety concern
            • statistically significant 29 % increase in Myocardial infarction
            • statistically significant 41 % increase in pulmonary embolism
            Hippisley-Cox OBSVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)controlCOVID-19 prophylaxis (excluding children)NA
            -/- safety concern
            • statistically significant 10 % increase in venous thromboembolism
            Patone OBSVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)controlCOVID-19 prophylaxis (excluding children)NA
            -/- safety concern
            • statistically significant 1.3-fold increase in Guillain-Barré syndrome
            • statistically significant 1.0-fold increase in Guillain-Barré syndrome
            Simpson (ChAdOx1) OBSVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)controlCOVID-19 prophylaxis (excluding children)NA
            -/- safety concern
            • statistically significant 98 % increase in immune thrombocytopenia
            Bernal (PHE, 19th February 2021) OBSVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)controlCOVID-19 prophylaxis (excluding children)NA
            -/- no results
              Burn (Vaxzevria) OBSVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)controlCOVID-19 prophylaxis (excluding children)critical
              -/- safety concern
              • statistically significant 1.0-fold increase in immune thrombocytopenia but with a very low degree of certainty due to critical risk of bias
              • statistically significant 23 % increase in pulmonary embolism but with a very low degree of certainty due to critical risk of bias
              • statistically significant 25 % increase in thrombocytopenia but with a very low degree of certainty due to critical risk of bias
              Edward (Vaxzevria) OBSVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)controlCOVID-19 prophylaxis (excluding children)critical
              -/- inconclusive
                Bernal unpublished OBSVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)controlCOVID-19 prophylaxis (excluding children)NA
                -/- suggested
                • suggested 55 % decrease in deaths,deaths
                Pottegard OBSVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)controlCOVID-19 prophylaxis (excluding children)critical
                -/- safety concern
                • statistically significant 1.3-fold increase in intracranial hemorrhage but with a very low degree of certainty due to critical risk of bias
                • statistically significant 79 % increase in pulmonary embolism but with a very low degree of certainty due to critical risk of bias
                • statistically significant 2.0-fold increase in thrombocytopenia but with a very low degree of certainty due to critical risk of bias
                • statistically significant 97 % increase in venous thromboembolism but with a very low degree of certainty due to critical risk of bias
                • statistically significant 19.3-fold increase in cerebral venous sinus thrombosis (CVST) but with a very low degree of certainty due to critical risk of bias

                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).