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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
    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%
    Fengcai
     
    NCT04566770
    RCTCanSino (Convidecia)placeboCOVID-19 prophylaxis (excluding children)NA
    320/110 safety concern
    • statistically significant 19.2-fold increase in systemic adverse reaction, any, dose 1
    • statistically significant 3.4-fold increase in systemic adverse reaction, any, dose 2
    Kulkarni
     
    CTRI/2020/08/027170
    RCTCovishield (Oxford/AZ formulation)placeboCOVID-19 prophylaxis (excluding children)NA
    1200/300 inconclusive
      There were no thromboembolic-associated or autoimmune-related SAEs
      Sadoff
       
      NCT04436276
      RCTJanssen AD26 vaccine (JNJ-78436735)placeboCOVID-19 prophylaxis (excluding children)NA
      -/- inconclusive
        Interim Results of a Phase 1–2a Trial : cohort 1 (healthy adults 18-55y) and 3 (>65y). Data that are reported here were collected after the administration of the second dose (either vaccine or placebo) in cohort 1a and after the first dose in cohort 3
        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)
          CanSino phase 2 (Zhu)
           
          NCT04341389
          RCTCanSino (Convidecia)placeboCOVID-19 prophylaxis (excluding children)NA
          382/126 inconclusive
            No serious adverse events were documented within 28 days
            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
            RESIST (Sputnik V Gamaleya Research Institute Russia)
             
            NCT04530396
            RCTSputnik V (Gam-COVID-Vac)placeboCOVID-19 prophylaxis (excluding children)high
            16501/5476 suggested
            • suggested 73 % decrease in confirmed Covid-19, from 1st dose but with a low degree of certainty due to high risk of bias
            • suggested 92 % decrease in symptomatic Covid-19 but with a low degree of certainty due to high risk of bias
            ENSEMBLE (COV3001) unpublished
             
            NCT04505722
            RCTJanssen AD26 vaccine (JNJ-78436735)placeboCOVID-19 prophylaxis (excluding children)some concern
            21895/21888 conclusif
            • suggested 81 % decrease in deaths with a moderate degree of certainty due to some concern in risk of bias
            • demonstrated 67 % decrease in symptomatic Covid-19 (PE) with a moderate degree of certainty due to some concern in risk of bias
            • suggested 82 % decrease in hospitalization 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 (Janssen) OBSJanssen AD26 vaccine (JNJ-78436735)controlCOVID-19 prophylaxis (excluding children)NA
              -/- safety concern
              • statistically significant 75 % increase in Myocardial infarction
              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
              Husby (janssen) OBSJanssen AD26 vaccine (JNJ-78436735)controlCOVID-19 prophylaxis (excluding children)NA
              -/- inconclusive
                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
                Nabirova OBSSputnik V (Gam-COVID-Vac)controlCOVID-19 prophylaxis (excluding children)NA
                -/- suggested
                • suggested 77 % decrease in new illness compatible with Covid-19
                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).