COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-35734p

Ana Luiza;Robson Valle;Santos

anavalle9@icloud.com; santos@icb.ufmg.br

2020-08-05

Recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

Age: less than 17 and less or equal to 81 years, Admission to the Intensive Care Unit with severe pneumonia criteria (clinical signs of pneumonia + one of the following criteria: respiratory rate greater than 30 irpm, signs of respiratory effort, SatO2 less than 90% in room air), COVID-19 confirmed or highly suspicious (positive contact or suggestive image)

Patients diagnosed with cancer (at any stage), Hemodynamic instability (need for vasopressors), Pregnant women, Immunocompromised patients, Exclusive Palliative Care, Inclusion in any other interventionist study, Heart failure as a predominant cause of acute respiratory failure, decompensated liver cirrhosis, HIV +, Dialysis, Home / long-term oxygen therapy, Idiopathic pulmonary fibrosis

2

Angitec

17

81

Brazil

Severe disease at enrollment

6: Severe disease at enrollment

0

Primary outcome: the primary outcome of the study will be the supplemental oxygen-free days (SOFDs) at 28 days.; defined as SOFDs = 28 - x; where x = number of days on which the patient is released from supplemental oxygen therapy after start.

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 85, "treatment_name": "Angiotensin 1-7", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}]