COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-9ksh5f4

Ana Marli Sartori

anasartori@gmail.com

2021-05-26

Not recruiting

nonRCT

Non-randomized

Single group assignment

Open label

unclear

Prevention

Adults aged from 18 to 59 years, belonging to one of the following groups: Solid organs transplant recipients - kidney, liver, heart and lung, Chronic Kidney disease pre-transplantation, Liver cirrhosis pre-transplantation, Hematopoietic stem cell transplantation, Cancer in active therapy, Adults with innate immunity errors, diseases with predominant antibody deficiency, Immune-mediated rheumatic diseases, Immunocompetent persons (comparator group)

Have previously received any Covid vaccine, History of allergy to any component of the vaccine, Have received any other vaccine up to 15 days before inclusion in the study, Acute illness or fever at the time of inclusion, Behavioral, cognitive or psychiatric illness that, in the opinion of the researchers, affects the ability to understand and collaborate with the requirements of the research protocol Alcohol or drug addiction, Any other condition that, according to the investigator's judgment, may prejudice the study procedures

1

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

18

59

Brazil

High risk patients

N/A

0

Expected Outcome 1: Frequency (%) of seroconversion 28 days after each dose of vaccine; for each participant group.Seroconversion will be defined by the presence of anti-SARS-CoV-2 antibodies after vaccination in participants with an absence of anti-SARS-CoV-2 antibodies before vaccination and / or at least a 4-fold increase in anti-SARS- antibody titers CoV-2 in participants with anti-SARS-CoV-2 antibodies prior to vaccination.;Expected Outcome 2: Geometric mean titers (GMT) of anti-SARS-CoV-2 antibodies before and 28 days after each dose of vaccine; for each group of participants;Expected Outcome 3: Frequency (%) of seropositivity at six and twelve months after completing the vaccination for each group of participant. ;Expected Outcome 4: Geometric mean titers (GMT) of anti-SARS-CoV-2 antibodies six and twelve months after the last vaccine dose for each group of participants;Expected Outcome 5: Frequency (%) of solicited and unsolicited; local and systemic adverse reactions; up to 7 days after each dose of the vaccine; for each group of participants;Expected Outcome 6: frequency (%) of serious adverse events throughout the study period for each group of participants;Expected Outcome 7: frequency (%) of adverse events of special interest (AESI) throughout the study period for each group of participants

Phase 4

[{"arm_notes": "2;Days0-28", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]