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Nebulized heparin in patients with mainly moderate coronavirus disease 2019: Randomized controlled trial. COVID-19

Nebulized heparin in patients with mainly moderate coronavirus disease 2019: Randomized controlled trial. COVID-19

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202007606032743
Enrollment
100
Registered
2020-07-07
Start date
2020-06-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID 19

Interventions

Standard of care plus nebulized heparin

Sponsors

Dr Tarek Ismail
Lead Sponsor
Dr Rabab S. Mahrous
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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. Incidence of serious respiratory events that need further respiratory support from randomization to 14 days.

Countries

Egypt

Contacts

Public ContactAmal Mohamed

Secretary of Research and opinion in Anesthesia and intensive care Journal

amalasaic@gmail.com+201281560053

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026