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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
        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
          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

          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).