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
Intravenous Immunoglobulin 0.4 g/kg body weight IV once daily for 5 days |
|
| Control
Standard care ( / ) Definition of Standard care: Standard of care consisted of Azithromycin; Lopinavir/ritonavir; Piperacillin + Tazobactam; Acetaminophen and Pantocid. Patients with co-morbid diseases such as diabetes and/or hypertension were given appropriate treatment. | |
| Participants | |
| Randomized 100 participants (n1=50 / n2= 50) | |
| Characteristics of participants N=100 Mean age : 48.7 33 males Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* Critical: n=0 | |
| 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 stated NR |
| 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. |