Trial *
Publication Majmundar M, medRxiv, 2020
Dates: 3/15/2020 to 4/30/2020
Methods | |
Non-randomized study | |
Location :
Single center / USA Follow-up duration (days): 56 | |
Inclusion criteria | Patients were eligible for the study if they met the following inclusion criteria are 1) Age 18 years old, 2) Confirmed cases of SARS-CoV-2 by PCR method, 3) Admitted in general wards, 4) PaO2/FiO2 (PF) ratio <300 if Arterial blood gas if available or SpO2/Fio2 (SF) ratio <440, 5) Bilateral infiltrate on chest imaging by radiology staff. |
Exclusion criteria | The exclusion criteria are 1) Patients with severe immunosuppression (HIV infection, long term use of immunosuppressive agents), 2) Pregnant woman or Lactation period, 3) Oral glucocorticoids were needed for other diseases, 4) Direct admission to intensive care unit (ICU), 5) if had any of primary composite outcome within first 24 hours of admission, 6) Patient who never required oxygen during the hospital course, 7) Patients who left against medical advice. |
Type of analysis | Multivariable Cox Regression |
Interventions | |
Treatment
Corticosteroids (MPS/Pred/HC/D) (80mg(IQR 60mg-107mg) MPS-equivalent doses) Co-Intervention: Standard care Duration : 5 days (IQR 4-7 days) |
|
Control
Standard care Definition of Standard care: * | |
Participants | |
N analyzed 205 participants (n1=60 / n2= 145) | |
Characteristics of participants N=205 Mean age : 57,6 153 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=* | |
Primary outcome | |
In the register NR | |
In the report composite outcome of intensive care unit (ICU) transfer, intubation, or death. | |
Documents avalaible |
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 |
Serious |
Notes | This is a non-randomized study. The published/pre-print article with the supplementary file were used in data extraction and risk of bias assessment.No study registry, protocol or statistical analysis plan was available. Multivariable Cox Regresssion analysis was used to generate the adjusted extracted outcomes Time to death and Time to clinical improvement (discharge). The baseline data from Table 1 is unadjusted proportions per arm (n=205). The study follow-up 56 days was calculated from the reported date 15 March to the reported end of follow up 10 May. |