Trial IRCT20151227025726N20
Publication Tabarsi P, Int Immunopharmacol, 2020 (published paper)
Funding: Public/non profit (Shahid Beheshti University of Medical Sciences)
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Single center / Iran Follow-up duration (days): 28 | |
| Inclusion criteria | Severely ill patients between 18 and 65 years old with COVID-19, confirmed based on the reports of Reverse Transcription-Polymerase Chain Reaction (RT-PCR) or bilateral pulmonary infiltration in computed tomography (CT) scan of the chest were included in the study. Severe pneumonia cases were determined based on World Health Organization (WHO) case definitions for COVID-19 consisting of the following: respiratory rates: ≥ 30 breaths/min, SpO2 ≤ 93%, and PaO2/ FiO2 ≤ 300 mmHg. |
| Exclusion criteria | Patients who denied signing the consent form; those with allergy reaction while injecting IVIg with severe extravasation and anaphylactic shock; mildly ill patients; patients recovering and improving upon Hydroxychloroquine, Lopinavir/Ritonavir, and supportive therapy; and pregnancy or breastfeeding. |
| Interventions | |
| Treatment
Intravenous Immunoglobulin 400 mg/kg IV once a day for 3 days |
|
| Control
Standard care Definition of Standard care: Patients in both groups received oxygen and fluid support, lopinavir/ ritonavir (200/50 mg, Hetero labs), two tablets twice a day, and hydroxychloroquine (Tehran-Daru) 200 mg two times daily. | |
| Participants | |
| Randomized 84 participants (n1=52 / n2= 32) | |
| Characteristics of participants N=84 Mean age : 53.6 65 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=84 Critical: n=0 | |
| Primary outcome | |
| In the register Need for mechanical ventilation, need of admission to critical care unit, and death. | |
| In the report Need for invasive mechanical ventilation and oxygenation, the need for admission to the Intensive Care Unit (ICU), and the mortality rate. | |
| 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 study protocol and statistical analysis plan were not available at time of extraction. The target sample size specified in the registry was achieved. Some outcomes that were reported (e.g., length of hospital stay, length of ICU stay, lab values) were not pre-specified in the registry. There is no change from the trial registration in the intervention and control treatments. All participants in the intervention group only were pre-medicated with hydrocortisone, paracetamol, and antihistamine 30 minutes before the IV Ig injection. |