COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04743011

Matheus Bertanha, PhD

matheusbertanha@gmail.com

2021-02-08

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - signature and agreement to the free consent form; - both sexes, of any ethnic origin, aged between 18 and 90 years; - covid-19 infected patients diagnosed by rt-pcr (reverse-transcriptase polymerase chain reaction) or with a strong suspicion of covid-19 by clinical evaluation through compatible clinical and radiological findings; - time of disease evolution less than 10 days; - radiological diagnosis of grade 2a pneumonia, with gas exchange ratio > 200 on blood gas analysis (pao2 / pfio2), characterizing mild hypoxemia; - indication of hospital treatment regime, provided that the period of hospitalization before inclusion is not more than 24 hours; - need for supplemental oxygen therapy (o2) less than 5l / min.

- no agreement to the terms of this study; - moderate or severe respiratory failure requiring admission to the icu and the need for invasive mechanical ventilation or non-invasive ventilation (niv) with positive pressure; - pregnancy or puerperium; - patients with hematological diseases, coagulation disorders, use of anticoagulants, previous heparin-induced allergy or thrombocytopenia, thrombocytopenia with a count of fewer than 50,000 platelets / mm3; - covid-19 not confirmed by rt-pcr within 72 hours of inclusion in the study.

2

UPECLIN HC FM Botucatu Unesp

18

90

Brazil

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

50

Change in activated partial thromboplastin time (APTT) > 1.5;Viral load in nasal swab reverse transcription polymerase chain reaction (RT-PCR).

None

Phase 1/Phase 2

[{"arm_notes": "Nebulized inhalation", "treatment_id": 1337, "treatment_name": "Unfractioned heparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]