Nebulised Heparin in Patients With COVID-19 Pneumonia

• Status: Not yet recruiting
• Trial end date: 2022-10-20
• Target enrollment: 0
• Participant gender: All

Summary

While the pandemic continues to incite panic and the guideline recommendations regarding management of COVID continue to change, we have growing evidence that ARDS secondary to Covid-19 is associated with disseminated intravascular and alveolar fibrin deposition1. Strategies devised to reduce mucous and fibrin plugs will greatly help in preventing patients from progressing to invasive ventilation2 which if happens will obviously overburden the compromised intensive care facilities. Offering heparin in nebulized form has greatly reduced levels of coagulation activation in the lungs both in animal studies and in patients with acute lung injury3. As Heparin prevents further fibrin deposition but is ineffective in the removal of pre-existing fibrin plug, so early use of heparin during the course of the disease may help in limiting the complications of ARDS and hence reducing the burden faced by our intensive care units.

A prospective randomized controlled trial will be carried out in patients admitted to COVID complex to see its effects on disease progression and its role in preventing patients from progressing to require Invasive Mechanical Ventilation while being administered through local route rather than systemic. Moreover, it will also give insight and way forward regarding the improvement in the survival and earlier discharge

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lady Reading Hospital, Pakistan
• Treatments: Calcium heparin; Heparin

Criteria

Inclusion Criteria:

1. Age 18 year or older.

2. Either gender

3. Currently admitted to hospital.

4. There is a PCR-positive sample for SARS-CoV-2 within the past 21 days. The sample can be a nasal or pharyngeal swab, sputum, tracheal aspirate, Broncho alveolar lavage, or another sample from the Patient

5. WHO Modified ordinal clinical scale 3-5

Exclusion Criteria:

1. Intubated and on mechanical ventilation, or requiring immediate intubation as per the treating clinician's assessment

2. Heparin allergy or heparin-induced thrombocytopenia

3. APTT >120 s, not due to anticoagulant therapy and does not correct with the administration of fresh frozen plasma

4. Platelet count <20 × 109 /L

5. Pulmonary bleeding or uncontrolled bleeding

6. Pregnant or might be pregnant

7. Acute brain injury that may result in long-term disability

8. Myopathy, spinal cord injury, or nerve injury or disease with a likely prolonged incapacity to breathe independently e.g. Guillain-Barre syndrome

9. Treatment limitations in place (Ceiling of care), i.e. not for intubation, not for ICU admission

10. Death is imminent or inevitable within 24 h

11. Clinician objection

12. Refusal to consent