Covid-19 Living Data

Trial RPCEC00000359
Publication Hernandez-Bernal F, SSRN, 2022
Dates: 2021-03-22 to 2021-04-03
Funding: Public/non profit (Center for Genetic Engineering and Biotechnology (CIGB), in Havana.)
Conflict of interest: Yes

Methods
	RCT
	Location : Multicenter / Cuba Follow-up duration (months): 3.4
	50mcg Abdala vaccine (n = 24146) placebo (n = 24144)
Inclusion criteria	Aged between 19 and 80 years healthy adults or with comorbidities, compensated written, informed consent to participate.
Exclusion criteria	Subjects with previous infection to SARS-CoV-2 confirmed by reverse-transcriptase polymerase chain reaction (RT-PCR) at the moment of inclusion, individuals suspicious to have the infection or in contact with a COVID-19 case, or previous any acute infections in the last 15 days chronic diseases decompensated at the time of inclusion subject who had received a vaccine candidate against COVID-19 any medical condition that requires an immunomodulator, systemic steroid or cytostatic during the study.
Interventions
	Intervention 3 IM doses of 50mcg Abdala vaccine, each 14 days apart
	Control 3 IM doses of placebo, each 14 days apart
Participants
	Randomized 48290 participants
	Characteristics of participants Type of participants: Adults N=48290 23004 males Children: 0 Pregnant women: 0 Mean age: Age range: NR
	Description of participants Adults, healthy or with controlled co-morbidities and no history of SARS-CoV-2 at 18 centers in Cuba
Primary outcome
	In the register Vaccine efficacy (Number of symptomatic COVID-19 subjects with no evidence of previous exposure to viral infection): Those subjects with SARS-CoV-2 positive RT-PCR who present at least one major symptom or sign will pay tribute to the efficacy evaluation or at least two of the minor symptoms or signs of COVID-19. Measurement time: from 14 days after the 3rd dose of the research product.
	In the report The efficacy of Abdala vaccine in preventing a first occurrence of symptomatic COVID-19, in individuals without evidence of prior exposure to SAR-CoV-2 infection with onset 14 days after the third dose of the immunization schedule
Documents available	Protocol NR Statistical plan * Data-sharing stated: Yes, On trial completion Data accessibility: Anonymised participant data will be made available when the trial is complete, upon requests directed to the corresponding author (hernandez.bernal@cigb.edu.cu). Proposals will be reviewed and approved by the sponsor, investigator, and collaborators on the basis of scientific merit. After approval of a proposal, data can be shared through a secure online platform after signing a data access agreement
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 pre-print article, the trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The primary outcomes in the article reflect those in the registry. The trial (n = 48290) achieved its target sample size (n = 48000). Supplementary appendices and figures 2,3 and 4 referred to in the article were not available via the pre-print website at time of extraction.