PACTR202007606032743.

Study name	Nebulized heparin in patients with mainly moderate coronavirus disease 2019: randomized controlled trial. COVID‐19
Starting date	15 June 2020
Contact information	Tarek Ismail Al Gamaa, Al Masaken Al Iqtisadeyah, Qism Helwan Cairo Egypt 00201112277417 | tareksalem00@gmail.com
Methods	RCT
Participants	100 participants, ≥ 18 years, female and male Inclusion criteria: Age:18‐60 years old Recently diagnosed (within 24 h) and moderate symptoms of the disease Ongoing SARS‐CoV‐2 infection confirmed in upper or lower respiratory tract specimens with RT‐PCR Willingness to participate Pneumonia on chest CT will not be mandatory for inclusion Exclusion criteria: Age < 18 years Severe conditions including malignancies, heart, liver, or kidney disease, poorly controlled metabolic diseases, pregnancy or lactation, severe hepatic impairment (e.g. Child Pugh grade C, ALT > five times the upper limit), severe renal impairment (estimated GFR 30 mL/min/1.73 m²), receipt of continuous renal replacement therapy, haemodialysis, peritoneal dialysis, allergy to heparin (including any history of HIT), pulmonary haemorrhage in the previous 3 months, uncontrolled bleeding or a significant bleeding disorder, an intracranial haemorrhage in the past 12 months Patients with mild and severe COVID‐19 will be excluded
Interventions	Standard care plus nebulised heparin, every 6 h started 24 h after randomisation and will continue for 1 week
Outcomes	Primary The primary outcome will be the average daily ratio of PaO2/FiO2 while the participant is on room air for 7 days Secondary Secondary outcomes will be levels in pulmonary lavage fluid of fibrin degradation products (FDPs) as a marker of coagulation activation, measured at baseline and on study days 3 and 7, it will be measured through mini bronchoalveolar lavage (BAL) fluid samples as patients remained non‐ventilated. Daily APPT levels in seconds and platelet count (× 109/L) will be recorded to assess the systemic effects of nebulised heparin Incidence of serious respiratory events that need further respiratory support from randomisation to 14 days
Notes	PACTR202007606032743 | No data provided