R S Raman1, Vijaykumar Bhagwan Barge2, Darivenula Anil Kumar3, Himanshu Dandu4, R Rakesh Kartha1, Varun Bafna2, Vishaly T Aravinda5, Thummala C Raghuram5. 1. Department of Medicine, Maharaja Agrasen Hospital, New Delhi, India. 2. Department of Medicine, Rajshree Chhatrapati Shahu Maharaj Government Medical College and CPR Hospital, Kolhapur, Maharashtra, India. 3. Department of General Medicine, Gandhi Medical College and Hospital, Hyderabad, Telangana, India. 4. Department of Medicine, King George's Medical College, Lucknow, Uttar Pradesh, India. 5. Department of Medical Affairs, Virchow Biotech Pvt. Ltd., Hyderabad, Telangana, India.
Abstract
BACKGROUND: Currently, there is no specific drug for the treatment of coronavirus disease 2019 (COVID-19). Therapeutic benefits of intravenous immunoglobulin (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. One hundred 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 the IVIG group compared with 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 with SOC. Percentages of patients on mechanical ventilation in 2 groups were not significantly different (24% vs 38%). Median time to reverse-transcription polymerase chain reaction 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 1 patient (2%), who died in SOC. CONCLUSIONS:Intravenous immunoglobulin was safe and efficacious as an adjuvant with other antiviral drugs in the treatment of COVID-19.
RCT Entities:
BACKGROUND: Currently, there is no specific drug for the treatment of coronavirus disease 2019 (COVID-19). Therapeutic benefits of intravenous immunoglobulin (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-19patients with moderate pneumonia. METHODS: An open-label, multicenter, comparative, randomized study was conducted on COVID-19patients with moderate pneumonia. One hundred 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 the IVIG group compared with 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 with SOC. Percentages of patients on mechanical ventilation in 2 groups were not significantly different (24% vs 38%). Median time to reverse-transcription polymerase chain reaction 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 1 patient (2%), who died in SOC. CONCLUSIONS: Intravenous immunoglobulin was safe and efficacious as an adjuvant with other antiviral drugs in the treatment of COVID-19.
Authors: Alessia Alunno; Aurélie Najm; Xavier Mariette; Gabriele De Marco; Jenny Emmel; Laura Mason; Dennis G McGonagle; Pedro M Machado Journal: RMD Open Date: 2021-10