NCT04836780.

Study name	Dexamethasone early administration in hospitalised patients with COVID‐19 pneumonia (EARLYDEXCoV2)
Methods	Trial design: prospective, multicentre, phase‐4, parallel‐group, open‐label RCT Sample size: 126 Setting: inpatient Language: Spanish, English Number of centres: no information Type of intervention (treatment/prevention): treatment
Participants	Inclusion criteria Adults (age ≥ 18 years) Diagnosed with SARS‐CoV‐2 infection by PCR or rapid antigen test on upper respiratory tract (nasopharyngeal and oropharyngeal) specimens Evidence of infiltrates on chest radiography or CT Peripheral capillary oxygen saturation (SpO2) ≥ 94% and < 22 breaths per min (bpm) breathing room air High risk of developing ARDS defined by a LDH > 245 U/L, C‐RP > 100 mg/L, and absolute lymphocytes < 800 cells/µL Eligible participants will meet 2/3 above analytical criteria associated with severe COVID‐19 Patients will provide written informed consent or who have a legally authorised representative available to do so. In these exceptional circumstances and following the recommendations of the Spanish Agency of Medicines and Medical Devices, the National Competent Authority of clinical trials, during the coronavirus crisis to avoid the risk of contagion, consent will be possible to obtained orally in the presence of at least one impartial witness. Exclusion criteria Patients with a history of allergy to dexamethasone Pregnant or lactating women Oral or inhaled corticosteroids treatment within 15 days before randomisation Immunosuppressive agent or cytotoxic drug therapy within 30 days before randomisation Neutropenia < 1000 cells/µL HIV infection with CD4 cell counts < 500 cells within 90 days after randomisation Dementia Chronic liver disease defined by ALT or AST ≥ 5 times the ULN Chronic kidney injury defined by a glomerular filtration rate ≤ 30 mL/min, haemodialysis or peritoneal dialysis Uncontrolled infection Patients who are already enrolled in another clinical trial
Interventions	Details of intervention: Dose: dexamethasone base 6 mg once daily for 7 days Route of administration: IV Treatment details of control group (e.g. dose, route of administration): standard care therapy Concomitant therapy: no information
Outcomes	Primary outcome The primary trial outcome is the development of moderate‐severe ARDS (time frame: 7 days), based on the Berlin criteria The collected data as outcome measure will be general vital signs, Sequential Organ Failure Assessment (SOFA) score, the clinical status of the patient using the ordinal scale of the WHO, SpO2, PaO2/FiO2 ratio calculated from SpO2/FiO2, blood routine tests and chest radiography Concomitant drugs and adverse event monitoring will be collected Data will be measured during admission Participants will schedule for a follow‐up visit on the 30th and 90th day to track their long‐term prognosis, clinical status and sequelae
Starting date	No information
Contact information	Anabel Franco Moreno, MD, PhD: +34 911 918000 Email: afranco278@hotmail.com
Notes	Recruitment status: recruiting Prospective completion date: 30 June 2021 Date last update was posted: 8 April 2021 Sponsor/funding: Hospital Universitario Infanta Leonor