Trial NCT04244591
Publication Steroids-SARI - Du, Unpublished (2020) ( )

Funding: Public/non profit (Peking Union Medical College Hospital, Zhongda Hospital, Zhongnan Hospital, Renmin Hospital of Wuhan University)
Conflict of interest: *

Methods
RCT
Blinding: Unblinded
Location : Multicenter / China
Follow-up duration (days): 30
Inclusion criteria
  • Adults PCR confirmed COVID-19 infection Symptoms developed more than 7 days PaO2/FiO2 < 200 mmHg Positive pressure ventilation (non-invasive or invasive) or high flow nasal cannula (HFNC) higher than 45 L/min for less than 48 hours Requiring ICU admission
Exclusion criteria
  • Pregnancy
  • Patients currently taking corticosteroids (cumulative 400 mg prednisone or equivalent)
  • Severe underlying disease, i.e. end stage of malignancy disease or end stage of pulmonary disease
  • Severe adverse events before ICU admission, i.e. cardiac arrest
  • Underlying disease requiring corticosteroids
  • Contraindication for corticosteroids
  • Recruited in other clinical intervention trial
Interventions
Treatment
Methylprednisolone
Control
Standard care


Participants
Randomized
participants :
Methylprednisolone=24
Standard care=23
Characteristics of participants
N= 47
Mean age : NR
35 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=20 Critical: n=27
Number of vaccinated participants: NR
Primary outcome
In the register
Lower Murray lung injury score [ Time Frame: 7 days after randomization ],
Lower Murray lung injury score [ Time Frame: 14 days after randomization ]
In the report
NR
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:
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
Some concerns
General comment The study is not published yet. Data presented was extracted from study registry, and Sterne, Jonathan AC, et al. "Association between Administration of Systemic Corticosteroids and Mortality among critically ill patients with COVID-19: a meta-analysis." Jama (2020). The authors have been contacted in order to obtain the results.