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A Phase II Safety and Efficacy Study on Prognosis of Moderate Pneumonia in COVID-19 patients with Regular Intravenous Immunoglobulin Therapy

Department of Medicine, Maharaja Agrasen Hospital, New Delhi, India. Department of Medicine, Rajshree Chhatrapati Shahu Maharaj Government Medical College and CPR Hospital, Kolhapur, Maharashtra, India. Department of General Medicine, Gandhi Medical College and Hospital, Hyderabad, Telangana, India. Department of Medicine, King George's Medical College, Lucknow, Uttar Pradesh, India. Department of Medical Affairs, Virchow Biotech Pvt. Ltd., Hyderabad, Telangana, India.

The Journal of infectious diseases. 2021
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PICO Summary

Population

COVID-19 patients with moderate pneumonia (n= 100).

Intervention

Intravenous immunoglobin (IVIG, n= 50).

Comparison

Standard of care (SOC, n= 50).

Outcome

Duration of hospital stay was significantly shorter in IVIG group to that of SOC alone (7.7 vs. 17.5 days). Duration for normalization of body temperature, oxygen saturation and mechanical ventilation were significantly shorter in IVIG compared to SOC. Percentages of patients on mechanical ventilation in two groups were not significantly different (24% vs. 38%). Median time to RT-PCR negativity was significantly shorter with IVIG than SOC (7 vs.18 days). There were only mild to moderate adverse events in both groups except for one patient (2%), who died in SOC.
Abstract
BACKGROUND Currently, there is no specific drug for the treatment of COVID-19. Therapeutic benefits of intravenous immunoglobin (IVIG) have been demonstrated in wide range of diseases. The present study is conducted to evaluate the safety and efficacy of IVIG in the treatment of COVID-19 patients with moderate pneumonia. METHODS An open-label, multicenter, comparative, randomized study was conducted on COVID-19 patients with moderate pneumonia. 100 eligible patients were randomized in 1:1 ratio either to receive IVIG + standard of care (SOC) or SOC. RESULTS Duration of hospital stay was significantly shorter in IVIG group to that of SOC alone (7.7 Vs. 17.5 days). Duration for normalization of body temperature, oxygen saturation and mechanical ventilation were significantly shorter in IVIG compared to SOC. Percentages of patients on mechanical ventilation in two groups were not significantly different (24% Vs. 38%). Median time to RT-PCR negativity was significantly shorter with IVIG than SOC (7 Vs.18 days). There were only mild to moderate adverse events in both groups except for one patient (2%), who died in SOC. CONCLUSIONS IVIG was safe and efficacious as an adjuvant with other antiviral drugs in the treatment of COVID-19. The trial was registered under Clinical Trial Registry, India (CTRI/2020/06/026222).
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine