Assessment of doubling dose of dexamethasone in progressively worsening severe COVID-19 pneumonia not responding to standard dose - an open-label pragmatic randomized controlled trial - ADDED

Animesh Ray0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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)]

•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.

发起方

Animesh Ray