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
IV Ig
400 mg/kg IV once a day for 3 days
Control
Standard care

Participants
Randomized
participants :
Standard care=32
IV Ig=52
Characteristics of participants
N= 84
Mean age : NR
65 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=84 Critical: n=0
Number of vaccinated participants: NR
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 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 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.