COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-8r9hy8f

Carlos Sverdloff

carsver@atcgen.com.br

2021-01-06

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

Patients hospitalized with COVID-19 who do not require immediate mechanical ventilation (points 3-5 on the ordinal scale). Age from 18 to 80 years. Able to understand the nature and purpose of the study, including risks and adverse effects and with the intention of cooperating with the researcher and acting in accordance with the requirements of the entire trial, which is confirmed by signing the Term Informed Consent Form, prior to any study procedure. Women of childbearing potential should use a safe and effective method of contraception throughout the study. If the participant chooses to abstain from sex or practice any type of relationship that does not pose a risk of pregnancy, the use of contraception is not mandatory.

The participant is known to be hypersensitive to the studied drug (heparin) or to chemically related compounds. History of serious adverse reactions or hypersensitivity to any drug. The participant has any condition that prevents him from participating in the study due to the investigator's judgment. A participant shows a positive result for beta-HCG test and/or urine test for pregnancy, delivery or abortion in the 12 weeks prior to the scheduled vaccine administration date. Present COPD.

2

Galeno Desenvolvimento de Pesquisas Clínicas Ltda

18

80

Brazil

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

0

The mortality rate in each arm of the study will be evaluated and compared;The time to hospital discharge (in days) in each arm of the study will be evaluated and compared

Phase 2

[{"arm_notes": "", "treatment_id": 873, "treatment_name": "Nebulised unfractionated heparin (ufh)", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]