Trial IRCT20200404046947N1
Publication Edalatifard M, Eur Respir J, 2020 (published paper)
Dates: 2020-04-20 to 2020-06-20
Funding: Public/non profit (Deputy of Research, Tehran University of Medical Sciences)
Conflict of interest: No
Methods | |
RCT Blinding: single blinding | |
Location :
Multicenter / Iran Follow-up duration (days): 60 | |
Inclusion criteria | Aged 18 years or older; Confirmed COVID-19 (RT-PCR); Abnormal computed tomography (CT) scan with blood oxygen saturation <90%, elevated C-reactive protein (CRP >10), and interleukin (IL)-6 (>6) at the early pulmonary phase of disease before connecting to the ventilator and intubation,agreed to give informed consent. |
Exclusion criteria | Patients intolerant or allergic to any therapeutic agents used in this research; Pregnant or lactating women; blood oxygen saturation <75%, positive pro-calcitonin (PCT) and troponin test, Acute Respiratory Distress Syndrome (ARDS), uncontrolled hypertension (HTN), uncontrolled diabetes mellitus (DM), gastrointestinal problems or gastrointestinal bleeding (GIB) history, heart failure (HF), active malignancies and received any immune-suppressor agents. |
Interventions | |
Treatment
Intravenous Methylprednisolone pulse 250 mg IV injection once a day for 3 days |
|
Control
Standard care Definition of Standard care: All patients received standard care (Hydroxychloroquine sulfate, Lopinavir, and Naproxen) for COVID-19 according to the protocol for diagnosis and treatment of COVID-19 in Iran | |
Participants | |
Randomized 68 participants (n1=34 / n2= 34) | |
Characteristics of participants N=68 Mean age : 58.8 39 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=68 Critical: n=0 | |
Primary outcome | |
In the register Radiographic features Findings | |
In the report time of clinical improvement and discharge from the hospital or death whichever came first | |
Documents available |
Protocol NR Statistical plan NR Data-sharing stated Yes |
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 study registry was used in data extraction and risk of bias assessment. The trial registration was updated between completion and submission of report manuscript for publication to change from double-blinded to single-blinded, increase the sample size from 40 to 68, and alter the timing of outcome measurement. The primary outcome and some other outcomes in the published report differ from those in the registration. There is no change from the trial registration in the intervention and control treatments. The primary outcome and some other outcomes in the published report differ from those in the registration. |