COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04789356

Marcus Lacerda, MD

marcuslacerda.br@gmail.com

2021-03-09

Unknown

nonRCT

Non-randomized

Parallel

Open label

single-center

Prevention

inclusion criteria: - age between 18 and 49 years - demonstrate availability to be accompanied during the follow-up time defined in the study, through visits, telephone contacts, or other means of digital communication.

- prior vaccination for covid-19; - diagnosis of covid-19 in the last 28 days (nasal and oropharyngeal swab); - history of severe allergic reaction or anaphylaxis to study vaccine components; - report of fever in the 72 hours prior to vaccination (the inclusion may be postponed until the participant completes 72 hours without fever); - possible or confirmed of covid-19 on the day of vaccination (in this situation, vaccination can be postponed until the participant completes 72 hours without symptoms or the diagnosis is ruled out); - have received live attenuated virus vaccine in the last 28 days or inactivated vaccine in the last 14 days prior to inclusion in the study, or have immunization scheduled for the first 28 days after their inclusion in the study; - any other condition that, in the opinion of the principal investigator or his medical representative, could endanger the safety or rights of a potential participant or that would prevent him or her from complying with this protocol; - pregnancy or breastfeeding.

2

Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

18

49

Brazil

Healthy volunteers

N/A

6233

Incidence density of moderate and severe clinical cases of COVID-19

None

Phase 4

[{"arm_notes": "600SU/dose;2;Day1-28;IM", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]