COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-7y8j2bs

Adriano Maeda

adriano.maeda@gmail.com

2021-02-10

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

Sign and agree to the Informed Consent Form, Both sexes, of any ethnic origin, aged between 18 and 90 years, COVID-19 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, 4. Time of disease evolution less than 10 days, 5. Radiological diagnosis of pneumonia grade 2 A, with gas exchange ratio> 200 on blood gas analysis (paO2 / pFiO2), characterizing mild hypoxemia, 6. Indication of hospital treatment regime, provided that the period of hospitalization before inclusion is not more than 24 hours, 7. Need for supplemental oxygen therapy (O2) less than 5L / min.

Do not agree with the terms of the study, Moderate or severe respiratory failure requiring admission to the Intensive Care Unit (ICU) with the need for invasive mechanical ventilation or non-invasive ventilation with positive pressure (NIV), Pregnancy or puerperium, People with hematological diseases, coagulation disorders, use of anticoagulants, previous heparin-induced allergy or thrombocytopenia, thrombocytopenia with a count of less than 50.000 platelets / mm3, No diagnostic confirmation of COVID-19 by RT-PCR within 72 hours of inclusion in the study.

2

Faculdade de Medicina de Botucatu - UNESP

18

90

Brazil

Moderate disease at enrollment

3: Moderate disease at enrollment

40

Safety: related to the use of inhalational high molecular weight heparin in patients with SARS-COV-2 through the assessment of hemorrhagic events of any nature; alteration of the coagulogram that indicates an increase in Activated Partial Thromboplastin Time (APTT)> 1; 5 and heparin-induced thrombocytopenia.;Efficacy: relative to the proposed treatment; through the analysis of the viral load of the SARS-COV-2 virus in the participants treated by the sequential evaluation of the viral load in RT-PCR of nasal Swab.

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

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 2394, "treatment_name": "High molecular weight inhalation heparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]