| Methods |
Trial design: open‐label, randomised trial
Sample size: 100
Setting: inpatient
Language: English
Number of centres: 1
Type of intervention (treatment/prevention): treatment |
| Participants |
Inclusion criteria
Age 18 to 80 Coronavirus‐19 infection (SARS‐CoV‐2) demonstrated by nasopharyngeal smears PCR or any other biological sample; COVID‐19 described as: nasopharyngeal smear with SARS‐CoV‐2 positive PCR, lung infiltrates by radiography (or other imaging technique) consistent with pneumonia, punctuation of 3 or 4 in the WHO Ordinal Scale for Clinical Improvement for COVID‐19; one of the following criteria: ambient air oxygen, saturation > 90% and < 94%, Pa: FiO2 (partial pressure O2/fraction of inspired O2) > 200 and ≤ 300 mmHg, Sa: FiO2 (O2 saturation measured with pulse oximeter/inspired O2 fraction) ≤ 350
Exclusion criteria
Previous treatment with oral or IV corticosteroids for > 5 days in a row or alternate days (6 previous months) Treatment during the previous 12 months with biological drugs such as monoclonal antibodies including anti‐TNFα, anti‐interleukins, interferons type I Any other contraindication for the use of individualised corticosteroid pulses according to the clinical criteria of the patient medical team Contraindications to treatment with methylprednisolone (limited to known hypersensitivity to the active substance and its excipients), as well as receiving treatment in a post‐vaccination period (with live or live attenuated micro‐organism vaccines) Patients with severe ARDS, defined as SaFi < 150 Patients with COPD requiring home oxygen
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| Interventions |
Details of intervention: methylprednisolone
Treatment details of control group (e.g. dose, route of administration): standard care
Concomitant therapy: no |
| Outcomes |
Primary outcome: incidence of a combined variable made up of the variables death, ICU admission, non‐IMV, or need for high‐flow oxygen therapy (defined as SaFi < 200 with FiO2 ≥ 50%) (day 90) |
| Notes |
Recruitment status: prematurely ended
Prospective completion date: estimated duration 1 year
Date last update was posted: no information
Sponsor/funding: Fundació Hospital Universitari Vall d'Hebron ‐ Institut de Recerca (VHIR) |
