Trial NCT04244591
Publication Du, Unpublished, 2020 ( )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 Definition of Standard care: * | |
Participants | |
Randomized 47 participants (n1=24 / n2= 23) | |
Characteristics of participants N=47 Mean age : NR 35 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=20 Critical: n=27 | |
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 stated No |
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. |