ebulized heparin in patients with mainly moderate coronavirus disease 2019: Randomized controlled trial. COVID-19
- Conditions
- COVID 19
- Registration Number
- PACTR202007606032743
- Lead Sponsor
- Dr Tarek Ismail
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
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 real time reverse transcriptase polymerase chain reaction (RT-PCR), willingness to participate. Pneumonia on computed tomography of the chest will not be mandatory for inclusion.
age below 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, alanine aminotransferase more than fivefold the upper limit), severe renal impairment (estimated glomerular filtration rate =30 mL/min/1.73 m2) , receipt of continuous renal replacement therapy, hemodialysis, peritoneal dialysis, allergy to heparin (including any history of heparin-induced thrombocytopenia), pulmonary hemorrhage in the previous 3 months, uncontrolled bleeding or a significant bleeding disorder, an intracranial hemorrhage in the past 12 months and patients with mild and severe COVID-19 will be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome will be the average daily ratio of partial pressure of oxygen to FiO2 (PaO2/FiO2) while the patient on room air for 7 days.
- Secondary Outcome Measures
Name Time Method 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 nebulized heparin.<br> Incidence of serious respiratory events that need further respiratory support from randomization to 14 days.<br>