Trial CTRI/2020/06/026222
Publication Raman RS, J Infect Dis (2021) (published paper)
Dates: 2020-06-29 to 2020-09-30
Funding: Private (Virchow Biotech)
Conflict of interest: Yes

Methods
RCT
Blinding: Unblinded
Location : Multicenter / India
Follow-up duration (days): 28
Inclusion criteria
  • Male or female aged ≥18 years
  • RT-PCR confirmed COVID-19 illness
  • Moderate pneumonia were defined as: body temperature ≥38.0℃ or PaO2/ FiO2 100-300 mmHg or respiratory rate >24/min and oxygen saturation 90-93% on room air or lung involvement confirmed with chest X-ray
Exclusion criteria
  • Viral pneumonia with other viruses besides COVID-19
  • Patients with IgA deficiency or history of anaphylaxis to immunoglobulin therapy
  • Patients with severe pneumonia were defined as: respiratory rate ≥ 30 times/min or oxygen saturation ≤90% in resting state or PaO2/FiO2 ≤100 mmHg or respiratory failure requiring mechanical ventilation or Intensive Care Unit (ICU) monitoring with signs of other organ failure
  • Patients on either immunoglobulin or hydroxychloroquine treatment
  • Female patients who are pregnant or lactating
Interventions
Treatment
IV Ig
0.4 g/kg body weight IV once daily for 5 days
Control
Standard care

Participants
Randomized
participants :
Standard care=50
IV Ig=50
Characteristics of participants
N= 100
Mean age : NR
33 males
Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Number of days to clinical improvement. It is defined as no. of days from initiation of treatment day to discharge day
In the report
Number of days from initiation of treatment to hospital discharge
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 accepted manuscript, the prospective study registry was used in data extraction and risk of bias assessment. Neither study protocol nor statistical analysis plan was available. The target sample size specified in the registry was achieved. There was no important change from the trial registration in the inclusion criteria or intervention and control treatments. Adverse events and serious adverse events were reported but were not pre-specified as outcomes in the registry.