Trial NCT04273321
Publication Tang X, Respiration (2021) (published paper)
Dates: 2020-02-19 to 2020-03-31
Funding: Public/non profit (Beijing Municipal Admin of Hospitals’ Mission Plan; Excellence Prog of Beijing Clin Key Specialty; Novel Coronavirus Pneumonia Key Tech R&D Funding of Beijing Municipal Admin of Hospitals)
Conflict of interest: No

Methods
RCT
Blinding: single blinding
Location : Multicenter / China
Follow-up duration (days): 30
Inclusion criteria
  • Patients who were laboratory confirmed of SARS-CoV-2 infection and had pneumonia confirmed by chest computed tomography
  • Aged 18 years or older
  • Admitted to the general wards for less than 72 h
  • Able to sign informed consent.
Exclusion criteria
  • Severe immunosuppression (human immunodeficiency virus infection and long-term use of immunosuppressive agents)
  • Pregnant or breastfeeding women
  • Corticosteroid needed for other diseases
  • Refractory hypertension, Epilepsy or delirium, glaucoma, active gastrointestinal bleeding within 3 months
  • Refractory hypokalemia, secondary bacterial or fungal infection
  • Unwilling or unable to participate or complete the study
  • Participation in other studies.
Interventions
Treatment
Methylprednisolone
1 mg/kg/day in 100 mL 0.9% normal saline IV for 7 days
Control
Placebo

Participants
Randomized
participants :
Methylprednisolone=43
Placebo=43
Characteristics of participants
N= 86
Mean age : NR
41 males
Severity : Mild: n=0 / Moderate: n=45 / Severe: n=41 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Incidence of treatment failure in 14 days [ Time Frame: 14 days ].
The clinical symptoms and signs continue to deteriorate, or new pulmonary or extrapulmonary lesions appear, or the chest imaging indicates the progress, and the patient is transferred to ICU or intubation and invasive ventilation or died.
In the report
Incidence of clinical deterioration 14 days after randomization.
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
Some concerns
General comment In addition to the published article, the prospective trial registry and supplementary materials were used in data extraction and assessment of risk of bias. There were no substantive changes between the trial registry and the published article in population, procedures and interventions. In addition to the outcomes included in the trial registry, the article reports the effect of methylprednisolone treatment of immune cell profile determined by mass cytometry. The study was terminated early and did not achieve its pre-stated target sample size due to a rapid decrease in potentially eligible patients.