Trial EudraCT202000193437
Publication GLUCOCOVID - Corral-Gudino L, medRxiv (2020) (preprint)
Dates: 2020-04-01 to 2020-05-31
Funding: No specific funding (The authors received no specific funding for this work)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : 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.
Interventions
Treatment
Methylprednisolone
40 mg IV infusion twice a day for 3 days, then 20 mg twice a day for 3 days.
Control
Standard care

Participants
Randomized
participants :
Methylprednisolone=35
Standard care=29
Characteristics of participants
N= 64
Mean age : NR
39 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=64 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
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)
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Not reported
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
High
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.