NCT04743011.

Study name	Nebulized enriched heparin to treat no critical patients with SARS‐CoV‐2 ‐ triple blind clinical trial
Starting date	1 June 2021
Contact information	Matheus Bertanha, PhD School of Medicine at Botucatu‐ Paulista State University‐ UNESP, São Paulo, Brazil Botucatu, SP, Brazil, 18607030 +55(14)3880‐1444 | matheusbertanha@gmail.com
Methods	Triple‐blind, parallel‐assignment RCT
Participants	50 participants, ≥ 18 years, female and male 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 or with a strong suspicion of COVID‐19 by clinical evaluation through compatible clinical and radiological findings Time of disease evolution < 10 days Radiological diagnosis of grade 2A pneumonia, with gas exchange ratio > 200 on blood gas analysis (paO2/pFiO2), characterising mild hypoxaemia Indication of hospital treatment regime, provided that the period of hospitalisation before inclusion is not more than 24 h Need for supplemental oxygen therapy (O2) < 5 L/min Exclusion criteria: 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 haematological diseases, coagulation disorders, use of anticoagulants, previous heparin‐induced allergy or HIT, thrombocytopenia with a count of < 50,000 platelets/mm³ COVID‐19 not confirmed by RT‐PCR within 72 h of inclusion in the study
Interventions	Experimental: heparin sodium Participants will receive inhalation with 5 mL 0.9% saline solution + 2.5 mg of high molecular weight heparin ‐ enriched heparin, 4/4 h, during the day period (5 doses) Comparator: placebo Participants will receive inhalation with 5 mL 0.9% saline solution (placebo), 4/4 h, during the day period (5 doses)
Outcomes	Primary Change in aPTT > 1.5 (time frame: immediately or up to 8 days after starting treatment) Viral load in nasal swab RT‐PCR (time frame: immediately or up to 8 days after starting treatment) Secondary Number of participants needing supplemental oxygen therapy (time frame: immediately or up to 8 days after starting treatment) Number of participants needing mechanical pulmonary ventilation (time frame: immediately or up to 8 days after starting treatment) Number of hospitalisation days (time frame: immediately or up to 8 days after starting treatment) Number of participants that develop renal failure (time frame: immediately or up to 8 days after starting treatment) Number of participants that develop major cardiovascular events (time frame: immediately or up to 8 days after starting treatment) Number of participants transferred to the ICU (time frame: immediately or up to 8 days after starting treatment) Number of participants presenting secondary pulmonary bacterial infections (time frame: immediately or up to 8 days after starting treatment) Number of participants that develop DVT (time frame: immediately or up to 8 days after starting treatment) Number of participants that develop pancreatitis (time frame: immediately or up to 8 days after starting treatment) Number of participants that need corticosteroid therapy (time frame: immediately or up to 8 days after starting treatment) Number of deaths among participants (time frame: immediately or up to 8 days after starting treatment) Number of participants with increased white blood cell count (time frame: immediately or up to 8 days after starting treatment) Number of participants with increased C reactive protein test (time frame: immediately or up to 8 days after starting treatment) Number of participants with deterioration of arterial blood gas PaO2/pFiO2 ratio (time frame: immediately or up to 8 days after starting treatment) Number of participants with altered sodium (time frame: immediately or up to 8 days after starting treatment) Number of participants with altered potassium (time frame: immediately or up to 8 days after starting treatment) Number of participants with increased pulmonary area compromised (%) (time frame: immediately or up to 8 days after starting treatment)
Notes	NCT04743011 | No data provided