COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57048

Dr Satish Swain

doctoranimeshray@gmail.com

2021-08-19

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

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)] <br/ >

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 â?¥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 â?¥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. <br/ >

2

Animesh Ray

18

99

India

Severe disease at enrollment

6: Severe disease at enrollment

120

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

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

Phase 3

[{"arm_notes": "12 mg", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "6 mg", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}]