COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-59447vn

Mauro Teixeira

mmtex.ufmg@gmail.com

2021-05-29

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

Male and female subjects, 18 to 85 years of age hospitalized with COVID-19 infection, Written informed consent, Confirmed COVID-19 by the presence of SARS-CoV-2 nucleic acid by polimerase chain reaction, Pregnancy is excluded or unlikely (reliable contraception/post-menopausal women).

Progress to death is imminent and unavoidable in the opinion of the investigator, Participating in other clinical trials (except in COVID-19 antiviral drug trials), Any condition that in the view of the screening physician suggests that the patient is unable to comply with study procedures, Subjects treated with immunosuppressive drugs, HIV infection, Pregnant women or breastfeeding mothers, Estimated glomerular filtration rate less than 30ml/min, Severe liver disfunction (Child-Pugh score C), Medical history of oral glucocorticoid treatment (Exception is COVID-19 dexamethasone treatment not exceeding 10mg/day).

2

Universidade Federal de Minas Gerais

18

85

Brazil

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

0

Days until respiratory recovery. The O2 saturation will be measured twice daily for all patients by a fingertip pulse oximeter. Primary outcome is achieved when O2 saturation is equal or grater than 93% in room air.

Phase 2

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