COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=66269

Dr Soujanya

drjohnpaulm@gmail.com

2022-02-18

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

Currently admitted to hospital <br/ >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, bronchoalveolar lavage, or another sample from the patient <br/ >Modified ordinal clinical scale 4-5 <br/ >

Intubated and on mechanical ventilation, or requiring immediate intubation as per the treating clinicianâ??s assessment <br/ >Heparin allergy or heparin-induced thrombocytopaenia <br/ >APTT > 120 seconds, not due to anticoagulant therapy and does not correct with administration of fresh frozen plasma <br/ >Platelet count < 20 x 109 per L <br/ >Pulmonary bleeding or uncontrolled bleeding <br/ >Pregnant or might be pregnant <br/ >Acute brain injury that may result in long-term disability <br/ >Myopathy, spinal cord injury, or nerve injury or disease with a likely prolonged incapacity to breathe independently e.g. Guillain-Barre syndrome <br/ >Treatment limitations in place, i.e. not for intubation, not for ICU admission <br/ >Death is imminent or inevitable within 24 hours <br/ >Clinician objection <br/ >Refusal of participant consent <br/ >

2

Sparsh Hospital Foundation

18

80

Australia;India;Ireland;Netherlands;Spain

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

712

The primary outcome is intubation (or death; for patients who died before intubation) before or at day 28 after randomisation.Timepoint: 28 Days

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 873, "treatment_name": "Nebulised unfractionated heparin (ufh)", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]