| Study characteristics |
| Methods |
Trial design: multicentre, open‐label, RCT
Type of publication: journal publication
Setting: inpatient
Recruitment dates: April to May 2020
Country: Spain
Language: English
Number of centres: 5 hospitals
Trial registration number: EUCTR 2020‐001934‐37
Date of trial registration: 8 May 2020 |
| Participants |
Age: mean age of:
Gender:
Proportion of confirmed infections: PCR positivity inclusion criterion
Ethnicity: not reported
Number of participants (recruited/allocated/evaluated):
Severity of condition according to study definition
Severity of condition according to WHO score: moderate to severe 5 to 6
Co‐morbidities: hypertension, cardiac disease, respiratory disease, diabetes
Inclusion criteria
Confirmed SARS‐CoV‐2 infection Symptom duration of at least 7 days Radiological evidence of lung disease on chest X‐ray or CT scan -
Moderate to severe disease with abnormal gas exchange:
Exclusion criteria:
Mechanical ventilation Hospitalised in the ICU Treated with corticosteroids or immunosuppressive drugs Chronic kidney disease on dialysis Pregnant Previous treatments: not reported
|
| Interventions |
Treatment details of intervention group (e.g dose, route of administration, number of doses)
Type of corticosteroid: methylprednisolone Dose: 40 mg for 3 days and then 20 mg for 3 days Route of administration: IV
Treatment details of control group (e.g. dose, route of administration, number of doses): standard care
Concomitant therapy (e.g. description of standard care): standard care included acetaminophen, oxygen therapy, low molecular weight heparin and antibiotics; azithromycin, hydroxychloroquine and lopinavir plus ritonavir
Duration of follow‐up: until hospital discharge or day 28 after inclusion
Treatment cross‐overs: no
Compliance with assigned treatment: yes |
| Outcomes |
Primary study outcome: composite endpoint including in‐hospital all‐cause mortality, escalation to ICU admission or progression of respiratory insufficiency that required noninvasive ventilation
Review outcomes: inpatient setting
Mortality: all‐cause mortality at day 14 or any longer observation period, in‐hospital all‐cause mortality: reported -
Improvement of clinical status during the longest observation period available:
Ventilator‐free days (defined as days alive and free from mechanical ventilation): not reported Participants discharged alive. Participants should be discharged without clinical deterioration or death: not reported
-
Deterioration of clinical status during the longest observation period available:
Serious adverse events, defined as the number of participants with any event: not reported Adverse events (any grade), defined as the number of participants with any event: reported Specific adverse events: hospital‐acquired infections: reported Fungal infections: not reported Quality of life, including fatigue and neurological status, assessed with standardised scales (e.g. WHOQOL‐100) during the longest period available: not reported New need for dialysis during the longest period available: not reported Viral clearance, assessed with reverse transcription polymerase chain reaction (RT‐PCR) test for SARS‐CoV‐2 at baseline, up to 3, 7, and 15 days: not reported
Additional study outcomes: composite endpoint included in‐hospital all‐cause mortality, escalation to ICU admission, or progression of respiratory insufficiency that required noninvasive ventilation |
| Identification |
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| Notes |
Date of publication: 3 February 2021
Sponsor/funding: IDIVAL Instituto de Investigación Sanitaria Valdecilla |
