CTRI/2021/08/035822.
| Study name | Assessment of doubling dose of dexamethasone in progressively worsening severe COVID‐19 pneumonia ‐ a randomised controlled trial |
| Methods | Trial design: open‐label, randomised controlled trial Sample size: 120 Setting: inpatient Language: English Number of centres: 1 Type of intervention (treatment/prevention): treatment |
| Participants | Inclusion criteria: patients aged 18 to 99 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 up to 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 haematological or solid malignancies with bone marrow invasion; refusal of consent. |
| Interventions | Details of intervention: dexamethasone
Treatment details of control group (e.g. dose, route of administration): dexamethasone, 6 mg, once daily, through intravenous or oral route, for 10 days or till discharge, whichever is earlier Concomitant therapy: not stated |
| Outcomes | Primary study outcome: supplemental oxygen‐free days at day 28 from hospitalisation, proportion of patients requiring non‐invasive ventilation by NIV mask or invasive mechanical ventilation |
| Starting date | 1 September 2021 |
| Contact information | Animesh Ray, All India Institute of Medical Sciences, New Delhi, Room no. 3070A, Department of Medicine, 3rd floor teaching block, All India Institute of Medical Sciences, New Delhi‐110029 South West DELHI 110029, India Phone: 01126593963 Email: doctoranimeshray@gmail.com |
| Notes | Recruitment status: not yet recruiting Prospective completion date: not stated Date last update was posted: 16 August 2021 Sponsor/funding: All India Institute of Medical Sciences, New Delhi |