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. 2022 Nov 17;2022(11):CD014963. doi: 10.1002/14651858.CD014963.pub2

NCT04451174.

Methods
  • Trial design: single‐blinded (outcomes assessor) RCT

  • Sample size: 184

  • Setting: inpatient

  • Language: Spanish, English

  • Number of centres: 1

  • Type of intervention (treatment/prevention): treatment

Participants Inclusion criteria
  • ≥ 18 years

  • COVID‐19 confirmed by PCR

  • Oxygen requirements until 35 % by Venturi mask or 5 L/min by nasal cannula

  • Consent form signed


Exclusion criteria
  • Previous steroid use ≥ 48 h

  • Pregnancy

  • Chronic respiratory failure

  • Requirements of mechanical ventilation (invasive or non‐invasive)

  • Chronic liver damage Child Pugh B or C

  • Chronic kidney disease stage IV or V

  • Immunosuppressed

  • Participation on other trial

Interventions Details of intervention
  • Dose: prednisone 40 mg days 1 to 4 then prednisone 20 mg days 5 to 8

  • Route of administration: IV


Treatment details of control group (e.g. dose, route of administration): no intervention
Concomitant therapy: no information
Outcomes Primary outcome
  • Admission to ICU

  • Need for IMV or

  • All‐cause death by day 28

  • (Time frame: 28 days)

Notes Recruitment status: terminated (corticosteroid use approval)
Prospective completion date: 3 December 2020
Date last update was posted: 20 October 2020
Sponsor/funding: University of Chile