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

COVID-19 prophylaxis (excluding childrens) meta-analysis

C4591031- first boost, 2021
 
NCT04955626
RCTfirst booster doseComirnaty (tozinameran - Pfizer/BIONTECH)COVID-19 prophylaxis (excluding childrens)low
5081/5044 conclusif
  • demonstrated 95 % decrease in confirmed COVID (any severity) (PE) with a high degree of certainty due to low risk of bias
C4591031- first boost, 2021
 
NCT04955626
RCTfirst booster dosecomplete primary vaccine seriesCOVID-19 prophylaxis (excluding childrens)low
5081/5044 conclusif
  • demonstrated 95 % decrease in confirmed COVID (any severity) (PE) with a high degree of certainty due to low risk of bias
C4591031- first boost, 2021
 
NCT04955626
RCTComirnaty - first boostComirnaty (tozinameran - Pfizer/BIONTECH)COVID-19 prophylaxis (excluding childrens)low
5081/5044 conclusif
  • demonstrated 95 % decrease in confirmed COVID (any severity) (PE) with a high degree of certainty due to low risk of bias
C4591031- first boost, 2021
 
NCT04955626
RCTComirnaty - first boostcomplete primary vaccine seriesCOVID-19 prophylaxis (excluding childrens)low
5081/5044 conclusif
  • demonstrated 95 % decrease in confirmed COVID (any severity) (PE) with a high degree of certainty due to low risk of bias
Hall, 2021
 
NCT04885907
RCTSpikevax (Moderna mRNA-1273 COVID-19 vaccine)COVID-19 prophylaxis (excluding childrens)some concern
60/60 ongoing
    Novavax phase 2 South Africa (2019nCoV-501), 2021
     
    NCT04533399
    RCTNuvaxovid (NVX-CoV2373) NovavaxplaceboCOVID-19 prophylaxis (excluding childrens)some concern
    2199/2188 suggested
    • suggested 49 % decrease in symptomatic Covid-19 (PE) with a moderate degree of certainty due to some concern in risk of bias
    Novavax PREVEND-19 phase 3 US (2019nCoV-301), 2021
     
    NCT04611802
    RCTNuvaxovid (NVX-CoV2373) NovavaxplaceboCOVID-19 prophylaxis (excluding childrens)low
    -/- suggested
    • suggested 90 % decrease in confirmed COVID (any severity) with a high degree of certainty due to low risk of bias
    BNT162b2 phase 3 (C4591001, Polack), 2020
     
    NCT04368728
    RCTComirnaty (tozinameran - Pfizer/BIONTECH)placeboCOVID-19 prophylaxis (excluding childrens)some concern
    21720/21728 conclusif
    • suggested 91 % decrease in 6 months symptomatic COVID with a moderate degree of certainty due to some concern in risk of bias
    • suggested 82 % decrease in confirmed Covid-19, from 1st dose with a moderate degree of certainty due to some concern in risk of bias
    • suggested 82 % decrease in vaccine efficacy from randomization (ITT) with a moderate degree of certainty due to some concern in risk of bias
    • demonstrated 95 % decrease in symptomatic Covid-19 (PE) with a moderate degree of certainty due to some concern in risk of bias
    • statistically significant 3.9-fold increase in related AE (TRAE) with a moderate degree of certainty due to some concern in risk of bias
    • statistically significant 1.6-fold increase in adverse events with a moderate degree of certainty due to some concern in risk of bias
    • statistically significant 74 % increase in severe adverse events with a moderate degree of certainty due to some concern in risk of bias
    • statistically significant 9.7-fold increase in lymphadenopathy, any with a moderate degree of certainty due to some concern in risk of bias
    • statistically significant 2.7-fold increase in musculoskeletal and connective tissue disorders, any with a moderate degree of certainty due to some concern in risk of bias
    • statistically significant 23.9-fold increase in local adverse reaction, any, dose 1 with a moderate degree of certainty due to some concern in risk of bias
    • statistically significant 22.0-fold increase in local adverse reaction, any, dose 2 with a moderate degree of certainty due to some concern in risk of bias
    • statistically significant 63 % increase in systemic adverse reaction, any, dose 1 with a moderate degree of certainty due to some concern in risk of bias
    • statistically significant 3.6-fold increase in systemic adverse reaction, any, dose 2 with a moderate degree of certainty due to some concern in risk of bias
    ChAdOx1 phase 3 (AstraZeneca), 2020
     
    NCT04400838
    RCTVaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)controlCOVID-19 prophylaxis (excluding childrens)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
    COVE Moderna/NIH phase 3 (study 301), 2020
     
    NCT04470427
    RCTSpikevax (Moderna mRNA-1273 COVID-19 vaccine)placeboCOVID-19 prophylaxis (excluding childrens)some concern
    15181/15170 conclusif
    • suggested 95 % decrease in confirmed Covid-19, from 1st dose with a moderate degree of certainty due to some concern in risk of bias
    • suggested 93 % decrease in vaccine efficacy from randomization (ITT) with a moderate degree of certainty due to some concern in risk of bias
    • demonstrated 94 % decrease in symptomatic Covid-19 (PE) with a moderate degree of certainty due to some concern in risk of bias
    • demonstrated 98 % decrease in severe COVID-19 occurrence (PE) with a moderate degree of certainty due to some concern in risk of bias
    • statistically significant 14 % increase in adverse events with a moderate degree of certainty due to some concern in risk of bias
    • statistically significant 17.4-fold increase in arthralgia, grade 3-4 with a moderate degree of certainty due to some concern in risk of bias
    • statistically significant 41 % increase in hypersensitivity, all terms with a moderate degree of certainty due to some concern in risk of bias
    • statistically significant 2.5-fold increase in lymphadenopathy, grade 3-4 with a moderate degree of certainty due to some concern in risk of bias
    • statistically significant 26.6-fold increase in myalgia, grade 3-4 with a moderate degree of certainty due to some concern in risk of bias
    • statistically significant 42.3-fold increase in fever, grade 3-4 with a moderate degree of certainty due to some concern in risk of bias
    • statistically significant 32.7-fold increase in local adverse reaction, any, dose 2 with a moderate degree of certainty due to some concern in risk of bias
    • statistically significant 14.0-fold increase in local adverse reaction, grade 3-4, dose 2 with a moderate degree of certainty due to some concern in risk of bias
    • statistically significant 5.7-fold increase in systemic adverse reaction, any, dose 2 with a moderate degree of certainty due to some concern in risk of bias
    • statistically significant 8.5-fold increase in systemic adverse reaction, grade 3-4, dose 2 with a moderate degree of certainty due to some concern in risk of bias
    ENSEMBLE (COV3001) unpublished
     
    NCT04505722
    RCTJanssen AD26 vaccine (JNJ-78436735)placeboCOVID-19 prophylaxis (excluding childrens)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
    244 studies excluded by filtering options (23 RCT / 221 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).