Trial IRCT20200501047259N1
Publication Gharebaghi N, BMC Infect Dis., 2020 (published paper)
Dates: 2020-05-09 to 2020-06-09
Funding: Public/non profit (Urmia University of Medical Sciences)
Conflict of interest: No

Methods
RCT
Blinding: double blinding
Location : Single center / Iran
Follow-up duration (days): *
Inclusion criteriaOver 18 years of age, possessing a PCR-confirmed COVID-19 diagnosis, involvement of > than 30% of both lungs (ground-glass opacity) in high resolution computed tomography (HRCT) (confirmed by two radiologists), O2 saturation (satO2) of < 90%, and a lack of adequate response to initial treatment including at least both one antiviral and one chloroquine-class drug.
Exclusion criteriaIn addition to an age of less than 18 years, included pregnancy, coagulation disorders (such as hemophilia, Von Willebrand disease, other clotting factor deciencies), history of hypersensitivity to IVIg, advanced heart failure (dened as a left ventricular ejection fraction less than 35%), pulmonary brosis/history of lung surgery, and the presence of either sarcoidosis or tuberculosis (that may interfere with an accurate estimation of the severity of pulmonary interference by COVID-19). Those patients who died before 72 hours after the distribution of IVIg and placebos were excluded from our study due to an incomplete course of treatment.
Interventions
Treatment
Intravenous Immunoglobulin
5 g IV four times a day for 3 consecutive days
Control
Placebo
Duration : 3 days
Participants
Randomized
59 participants (n1=30 / n2= 29)
Characteristics of participants
N=59
Mean age : NR
41 males
Severity : Mild: n=0 / Moderate: n=0/ Severe: n=* Critical: n=*
Primary outcome
In the register
Increasing of patient's O2 saturation above 90%, improvement of lung involvement in lung CT scan
In the report
In-hospital mortality
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
*
General comment This study is pending author reply. The timepoints for outcomes were not reported.

In addition to the pre-print article, the study registry was used in data extraction and risk of bias assessment. The study achieved the target sample size reported in the registry. There is no change from the trial registration in the intervention and control treatments. Safety analysis was not performed.