Covid-19 Living Data

Trial NCT05047640
Publication Natori Y, Transpl Int, 2023
Dates: 2021-09-14 to 2021-12-31
Funding: Not reported/unclear
Conflict of interest: no COI

Methods
	RCT
	Location : Single center / USA Follow-up duration (months): 1
	BNT162b2 = (n=30) Ad26.COV2.S = (n=30)
Inclusion criteria	Patients 18 years of age and older Patients who had received a solid organ (kidney, liver, lung, heart, and pancreas) transplant patient from living or deceased donors. Patients with active graft with at least one immunosuppressive medication Completed two doses of BNT162b2 vaccination at least 28 days ago
Exclusion criteria	Patient with non-active graft Any significant side effect with previous COVID-19 vaccination Within 28 days of BNT162b2 vaccine completion Already received more than and equal to three doses of COVID-19 vaccination Previously received COVID-19 vaccine other than BNT162b2 vaccine Previously received monoclonal Antibody treatment that are specifically directed against the spike protein for Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (CoV)-2 such as Mab, Bamlanivimab, etesevimab, Casirivimab, imdevimab, Sotrovimab and/or any combination. Thrombocytopenia (if less than 50,000 per microliter 30 days prior vaccination) History of Capillary Leak Syndrome Adults unable to consent Individuals who are not yet adults (younger than 18 year old) Vulnerable patients (prisoners) Pregnant women
Interventions
	Intervention 1 IM dose of Ad26.COV2.S at least 28 days after the second dose of BNT162b2
	Control 1 IM dose of BNT162b2 at least 28 days after the second dose of BNT162b2
Participants
	Randomized 60 participants
	Characteristics of participants Type of participants: Transplant recipients N=60 38 males Children: 0 Pregnant women: 0 Immunocompromized patients: 58 Mean age: Age range: 27-76
	Description of participants Transplants recpients 18 years of age or older who had received 2 doses of BNT162b2, in a single center in USA.
Primary outcome
	In the register Percentage of Participants Who Tested Positive for IgG Antibodies to the Anti-spike Protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) [ Time Frame: Up to 1 month (post booster vaccination) ] Anti-spike protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) virus Immunoglobulin G (IgG) positivity rate will be assessed from serum blood samples
	In the report Anti-spike protein SARS- CoV-2 IgG positivity after 28 (21–35) days of the booster dose
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing stated: No Data accessibility: Giselle Guerra, gguerra@med.miami.edu
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 all available versions of the published/pre-print article, the study registry was used in data extraction and risk of bias assessment. The study was terminated early due to "Difficulty in recruitment". As a result, the target sample size (n=186) was not achieved (n= 60). Results were retrieved from the registry. There were no important differences between registry and published report in population, procedures and interventions.However, the timepoints of the outcomes reported were different between registry/protocol and report (6 month in the regsitry and protocol, vs 1 month in the report).