Inhaled HEP for COVID 19

Phase 2

Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Registration Number: CTRI/2022/02/040418

Lead Sponsor: Sparsh Hospital Foundation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Currently admitted to hospital

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

Modified ordinal clinical scale 4-5

Exclusion Criteria

Intubated and on mechanical ventilation, or requiring immediate intubation as per the treating clinicianâ??s assessment

Heparin allergy or heparin-induced thrombocytopaenia

APTT > 120 seconds, not due to anticoagulant therapy and does not correct with administration of fresh frozen plasma

Platelet count < 20 x 109 per L

Pulmonary bleeding or uncontrolled bleeding

Pregnant or might be pregnant

Acute brain injury that may result in long-term disability

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

Treatment limitations in place, i.e. not for intubation, not for ICU admission

Death is imminent or inevitable within 24 hours

Clinician objection

Refusal of participant consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The secondary outcomes are: <br/ ><br>â?¢Survival to day 28 and Survival to hospital discharge, censored at day 28 <br/ ><br>â?¢Daily ratio of oxygen saturation by pulse oximetry to the fraction of inspired oxygen (SpO2/FiO2 ratio, highest and lowest levels) <br/ ><br>â?¢Daily change in modified ordinal score from baseline to day 28 <br/ ><br>Timepoint: 28 Days