Trial EudraCT number: 2020-001934-37
Publication Corral-Gudino L, medRxiv, 2020
Dates: 2020-04-01 to 2020-05-31
Funding: No specific funding (The authors received no specific funding for this work)
Multicenter / Spain |
Follow-up duration (days): 28
|Inclusion criteria||Eligible patients were hospitalized subjects over 18 years of age, with a laboratory confirmed diagnosis of SARS-CoV2 infection. Additional inclusion criteria were all the following: 1) Symptom duration of at least 7 days 2) Radiological evidence of lung disease in chest X-ray or CT-scan 3) Moderate-to-severe disease with abnormal gas exchange: PaFi (PaO2/FiO2) < 300, or SAFI (SAO2/FiO2) < 400, or at least 2 criteria of the BRESCIA-COVID Respiratory Severity Scale (BCRSS) . 4) Laboratory parameters suggesting a hyper-inflammatory state: serum C-Reactive Protein (CRP) >15 mg/dl, D-dimer > 800 mg/dl, ferritin > 1000 mg/dl or IL-6 levels > 20 pg/ml.|
|Exclusion criteria||Patients were excluded if they were intubated or mechanically ventilated, were hospitalized in the ICU, were treated with corticosteroids or immunosuppressive drugs at the time of enrollment, have chronic kidney disease on dialysis, were pregnant or refused to participate.|
Methylprednisolone (40mg D1-D3 then 20mg D4-D6)
Co-Intervention: Standard care
Duration : 6 days
Definition of Standard care: SOC included symptomatic treatment with acetaminophen, oxygen therapy, thrombosis prophylaxis with low molecular weight heparin, and antibiotics for co-infections. Azythromycin, hydroxychloroquine and lopinavir plus ritonavir were frequently prescribed. Biochemical tests and image studies were performed according to clinical criteria and local protocols, using standard techniques. The clinical teams freely prescribed Interleukin-blocking agents and other therapies, as indicated.
64 participants (n1=64 / n2= 29)
|Characteristics of participants|
Mean age : 69.8
Severity : Mild: n=0 / Moderate: n=*/ Severe: n=64 Critical: n=0
|In the register|
Combination of death, ICU stay or non-invasive ventilation (NIV).
|In the report|
composite endpoint that included in-hospital all-cause mortality, escalation to ICU admission, or progression of respiratory insufficiency that required non-invasive ventilation (NIV).
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
|General comment||In addition to all available versions of the pre-print article, the study registry, the CAF reply and mail request for data reply was used in data extraction and risk of bias assessment. This is a report on preliminary results from an interim analysis. There is no change from the trial registration in the intervention and control treatments. Primary outcome in the registry and report is the same.|