NCT04726098.

Study name	Low or high dose of dexamethasone in patients with respiratory failure by COVID‐19 (HIGHLOWDEXA)
Methods	Trial design: open‐label RCT Sample size: 198 Setting: inpatient Language: Spanish, English Number of centres: no information Type of intervention (treatment/prevention): treatment
Participants	Inclusion criteria Age ≥ 18 years Hospitalised COVID‐19 patients admitted to the Hospital Patients requiring supplemental oxygen Level 4 using the WHO 7‐point Ordinal Scale for clinical improvement Patients requiring corticosteroids (dexamethasone) according to hospital protocol Exclusion criteria Pregnancy or active lactation Patient is expected to die in the next 48 h Known history of dexamethasone allergy or known contraindication to the use of corticosteroids Daily use of corticosteroids in the past 15 days Indication for corticosteroids use for other clinical conditions (e.g. refractory septic shock) Consent refusal for participating in the trial Different level from 4 using the WHO 7‐point Ordinal Scale for clinical improvement
Interventions	Details of intervention Dose: dexamethasone 6 mg/day for 10 days Route of administration: most likely systemic Treatment details of control group (e.g dose, route of administration):   dexamethasone 20 mg/day for 5 days + dexamethasone 10 mg/day for 5 days (total 10 days) Concomitant therapy: no information
Outcomes	Primary outcome: percentage of patients with treatment failure at day 11 defined as death, need of ICU and ECMO, need of NIV or nasal high‐flow oxygen therapy, or worsening of the clinical condition of the patient during treatment (2 of these: need to increase: fraction of inspired oxygen inspired > 20%, need for fraction inspired oxygenation > 50%, increase in respiratory rate > 25, increase in inflammatory markers)
Starting date	15 January 2021
Contact information	Manuel Taboada Muñiz, Ph.D.+34678195618  NCT04726098, HIGHLOWDEXA‐COVID, Low or High Dose of Dexamethasone in Patients With Respiratory Failure by COVID‐19" type="EXTERNAL">manutabo@yahoo.es
Notes	Recruitment status: recruiting Prospective completion date: estimated primary completion date 30 June 2021; estimated study completion date 31 December 2022 Date last update was posted: 27 January 2021 Sponsor/funding: Manuel Taboada Muñiz