Assessment of doubling dose of dexamethasone in progressively worsening severe COVID-19 pneumonia - a randomized controlled trial

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Patients aged at least 18 years, hospitalised, confirmed SARS-CoV-2 infection by nucleic acid based testing (RT-PCR, CB-NAAT, or TrueNAT) or antigen testing, Severe COVID-19 pneumonia (SpO2 <94%; PaO2/FiO2 <300 mm Hg or respiratory rate(RR) >30 breaths/min) with lack of response to Dexamethasone 6 mg after 48 hours [defined as similar or worsening oxygen requirement (margin of error is 5% Fio2 for high flow nasal cannula, 2 L/min for NRBM, and 1 L/min for low flow oxygen devices)]

Exclusion Criteria

Patient already on corticosteroid therapy for an unrelated indication; Patient with impending death or respiratory failure necessitating ICU care within 24 hours including inability to maintain SpO2 >=90% despite HFNC with flow 60 L/min and FiO2 1.0 or ,if available, NIV with PEEP of upto 8 cm H2O and FiO2 1.0; Patients who have received >=2 day of steroids outside hospital care or within the hospital outside of wards that are involved in the study. These doses must be no greater than 12 mg dexamethasone or 64 mg methylprednisolone cumulatively; Patients with a known contraindication to corticosteroids including untreated bacterial sepsis, diabetic keto-acidosis, and invasive fungal infections such as mucormycosis; medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial; Pregnancy; Recruitment in another therapeutic trial; Use of immunosuppressive drugs, cytotoxic chemotherapy in the past 21 days; Neutropenia due to hematological or solid malignancies with bone marrow invasion; Refusal of consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Supplemental oxygen-free days at day 28 from hospitalization <br/ ><br>Proportion of patients requiring non-invasive ventilation by NIV mask or invasive mechanical ventilationTimepoint: Day 28 from hospitalisation, during hospital course

Secondary Outcome Measures

Name	Time	Method
All cause mortality at day 28 from hospitalizationTimepoint: Day 28 from hospitalisation;Clinical status after 5 as well as 10â??days after hospitalization with 9-point WHO ordinal scaleTimepoint: Day 5 and 10 after hospitalisation;Hospital length of stayTimepoint: At death/discharge;In-hospital mortalityTimepoint: At death/discharge;Number of days to requirement for NIV or invasive mechanical ventilationTimepoint: During Hospital course;Proportion of patients requiring antimicrobial therapy for suspected hospital acquired infection (bacterial or fungal)Timepoint: During hospital course;Severity of steroid induced hyperglycemia including average daily glucose measurements and average daily insulin administered per kilogram body weight from day 1-5 after randomizationTimepoint: Day 1-5 after randomisation during hospital course