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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
      Li J
              NCT04892459      		 RCTCanSino (Convidecia)CoronaVac (SinoVac)COVID-19 prophylaxis (excluding children)NA
      		147/152 inconclusive
        No thromboses, vaccine-related anaphylaxis or other serious adverse events were observed in any of the groups by day 28 after the booster
        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
          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
            Reindl-Schwaighofer RCTJanssen AD26 vaccine (JNJ-78436735)Comirnaty (tozinameran - Pfizer/BIONTECH)COVID-19 prophylaxis (excluding children)NA
            		100/101 inconclusive
              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
                    15 studies excluded by filtering options (0 RCT / 15 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).

                     

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