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. 2021 Aug 16;2021(8):CD014963. doi: 10.1002/14651858.CD014963

NCT03852537.

Methods Trial design: double‐blinded RCT
Sample size: 44
Setting: inpatient
Language: English
Number of centres: 1
Type of intervention (treatment/prevention): treatment
Participants Inclusion criteria
  • Patients admitted to hospital with COVID‐19 pneumonia (high suspicion or confirmed by positive SARS CoV‐2 testing). 

  • Acute respiratory failure SpO2/FiO2 < 315 (SpO2 < 90% on room air or < 97% on 2L NC)


Exclusion criteria
  • Contraindications or unwilling to use steroids by patient or provider

  • Refractory septic shock defined as a requirement of norepinephrine dose or equivalent above > 0.1 microgram/kg/min or 2 or more vasopressors

  • Pre‐admission chronic use of steroids or other immunosuppressive medications

  • Adrenal insufficiency

  • Comfort care

  • Leukopenia < 1000/mm or neutropenia < 500/mm (except if attributable to pneumonia)

  • HIV positive with a CD4 count < 100

  • Recent or past history of bone marrow or solid organ transplantation

  • Suspected flare of interstitial lung disease (infectious and non‐infectious)

  • Positive influenza testing or high suspicion for influenza

Interventions Details of intervention
  • Dose: methylprednisolone will be administered based on CRP‐guided protocol outlined under 'Biomarker‐adjusted steroid dosing'

  • Route of administration: no information


Treatment details of control group (e.g dose, route of administration):  usual care as determined by the patients treatment team.
Concomitant therapy: no information
Outcomes Primary study outcome: fasibility of the timely initiation of corticosteroids and implementation of biomarker‐titrated corticosteroid dosing: percentage of eligible patients adhered to the timely initiation (time frame: within 30 days of enrolment in study)
Notes Recruitment status: completed
Prospective completion date: 15 March 2021
Date last update was posted:  13 April 2021
Sponsor/funding: Mayo Clinic