COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-2xd6dkj

Edison Fedrizzi

enfedrizzi@uol.com.br

2021-02-12

Recruiting

RCT

Randomized

Parallel

Blind label

unclear

Prevention

Men and women from 18 to 60 years old (inclusive) in Visit 1, volunteers, who in the opinion researchers, are able to fulfill the requirements of the Protocol (carry out all visits, fill in the post-vaccination diary and no intention of moving to another city), obtaining the Term of Free and Informed Consent (FICT) signed, after reading and discussing it, before taking any procedure

Women who are pregnant or wishing to become pregnant during the study period, women who are breastfeeding, subjects with immune system deficiency (HIV or who are performing or performed in the last 90 days treatments such as chemotherapy, radiation therapy, high doses of corticosteroids (greater than 20 mg / day for more than 14 days) or immunosuppressants), receptors of immunoglobulins or blood products in the last 180 days, people with decompensated autoimmune diseases, such as systemic lupus erythematosus, sclerosis multiple, Guillain-Barré syndrome, myasthenia gravis, scleroderma, have received an attenuated vaccine in the last 30 days or inactivated in the last 15 days, fever greater than 37.8 degrees Celsius and / or inflammatory / infectious oropharyngeal process, previous history of positive test for SARS-CoV-2 by PCR or Rapid Test or serology, Covid-19 suspected clinical history and / or physical examination, such as fever (greater than 38 degrees Celsius), odynophagia, cough, dyspnoea and anosmia, anaphylactic-type hypersensitivity to any component of the vaccine, any other clinical condition that, at the discretion of the investigator, may interfere with the results of the study or may bring some risk to the study volunteer, it's be participating or wish to participate in another study that is evaluating the use of another vaccine.

2

Universidade Federal de Santa Catarina

18

60

Brazil

Health workers

N/A

1000

Assess whether the MMR vaccine will prevent and / or decrease the severity of COVID-19 in adult men and women aged 18 to 60; health professionals

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 4

[{"arm_notes": "", "treatment_id": 2556, "treatment_name": "Mmr vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]