Covid-19 Living Data

Trial NCT04805125
Publication Speich B, Clin Infect Dis, 2022
Dates: 2021-04-19 to 2021-06-09
Funding: Mixed (Swiss National Science Foundation, University of Zurich Foundation, Promedica Foundation. Roche Switzerland provided the antibody tests (Elecsys Anti-SARS-CoV-2) free of charge.)
Conflict of interest: Yes

Methods
	RCT
	Location : Multicenter / Switzerland Follow-up duration (months): 3
	BNT162b2 (n=215) mRNA-1273 (n=215)
Inclusion criteria	Aged 18 years or older living with HIV (PLWH) or solid organ transplant recipients (SOTR i.e. lung and kidney) COVID-19 vaccination was recommended by the treating physician.
Exclusion criteria	Pregnant women patients with any acute respiratory tract infection SARS-CoV-2 positive patients with an infection occurring in the last 3 months persons with any emergency condition requiring immediate hospitalisation organ transplant recipients who received the new organ within the last month had received T-cell depleting agents within the last 3 months received pulse corticosteroids (within the last months) rituximab (within the last 6 months) or if they were in need of chemotherapy treatment.
Interventions
	Intervention 2 IM doses of 30 mcg BNT162b2, 28 days apart
	Control 2 IM doses of 100 mcg mRNA-1273, 28 days apart
Participants
	Randomized 430 participants
	Characteristics of participants Type of participants: People living with HIV, Solid organ transplant recipients N=430 326 males Children: 0 Pregnant women: 0 Immunocompromized patients: 430 Mean age: Age range: NR
	Description of participants Adult patients living with HIV (PLWH) or solid organ transplant recipients who were SARS-CoV-2 infection-free for the last 3 months in 3 centres in Switzerland.
Primary outcome
	In the register 1) immunological outcome: change in pan-Ig antibody response (pan-Ig anti-S1-RBD) [ Time Frame: at baseline (day of vaccination) and three months after vaccination ] A commercial immunoassay Elecsys® Anti-SARS-CoV-2 S for the in vitro quantitative determination of antibodies to the SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human serum and plasma is used. This assay detects pan-Ig antibody response (pan-Ig anti-S1-RBD) and allows for a quantitative assessment of the serological response of the participants.; 2)immunological outcome: change in anti-Nucleocapsid (N) response [ Time Frame: at baseline (day of vaccination) and three months after vaccination ]; 3) immunological outcome: change in SARS-CoV-2-binding antibodies [ Time Frame: at baseline (day of vaccination) and three months after vaccination ]; 4) Number of participants with newly polymerase chain reaction (PCR)-confirmed asymptomatic COVID-19 infection [ Time Frame: at any time point in within 48 weeks following randomisation (day of vaccination) ]; 5)Number of participants with newly PCR-confirmed symptomatic COVID-19 infection [ Time Frame: at any time point in within 48 weeks following randomisation (day of vaccination) ]; 6) Number of participants with severe COVID-19 infection [ Time Frame: at any time point in within 48 weeks following randomisation (day of vaccination) ]; 7) Clinical Outcome: COVID-19 burden of diseases (BOD) [ Time Frame: within 48 weeks following randomisation (day of vaccination) ]; 8) Duration of RCT set up (specific endpoint related to trial conduct feasibility) [ Time Frame: one time assessment at baseline (from deciding which interventions will be tested until the first patient is randomised) ]; 9) Time of patient recruitment from activation of first study site until 40 patients are randomised [ Time Frame: one time assessment after approx. 3 months (from activation of first study site until 40 patients are randomised) ]; 10) Time of patient recruitment from activation of first study site until 380 patients are randomised [ Time Frame: one time assessment after approx. 3 months (from activation of first study site until 380 patients are randomised) ]; 11) Patient consent rate [ Time Frame: approx. 3 months ]; 12) Proportion of missing data for all baseline variables from routinely collected cohort data [ Time Frame: one time assessment at baseline ]; 13) Proportion of missing data for all clinical outcomes [ Time Frame: one time assessment after approx. 3 months ]; 14) SARS-CoV-2-specific antibodies [ Time Frame: three months after vaccination ]; 15) SARS-CoV-2-specific titers [ Time Frame: three months after vaccination ]; 16) The proportion of patients with a positive antibody response to SARS-CoV-2 spike (S1) protein receptor binding domain in human serum or plasma assessed in the observational second sub- protocol [ Time Frame: 8 weeks (¨+/- 2 weeks) after 3. vaccination ]
	In the report Positive antibody response to SARS-CoV-2 spike (S1) protein receptor binding domain in human serum or plasma assessed by the commercial immunoassay Elecsys Anti-SARS-CoV-2 S (Elecsys S) from Roche Diagnostics. The outcome is binary using a threshold of ≥0.8 units/ml as defined by the manufacturer.
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing stated: NR Data accessibility: Benjamin Speich, benjamin.speich@usb.ch
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the published article, the protocol, statistical analysis plan, appendix and study registry were used in data extraction and risk of bias assessment. Only one of 15 primary outcomes listed in the registry (which is for a trial platform) was identified as the primary outcome in the article. The trial (n = 430) achieved its target sample size (n = 430).