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DOI 10.1093/infdis/jiab098

Медицинская библиотека · The Journal of infectious diseases · 2021

A Phase II Safety and Efficacy Study on Prognosis of Moderate Pneumonia in Coronavirus Disease 2019 Patients With Regular Intravenous Immunoglobulin Therapy.

Raman R S, Bhagwan Barge Vijaykumar, Anil Kumar Darivenula, Dandu Himanshu, Rakesh Kartha R, Bafna Varun, Aravinda Vishaly T, Raghuram Thummala C

Клиническое исследование II фазыСравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАПеревод в очереди

Аннотация

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.

Для цитирования: Raman R S, Bhagwan Barge Vijaykumar, Anil Kumar Darivenula, Dandu Himanshu, Rakesh Kartha R, Bafna Varun, Aravinda Vishaly T, Raghuram Thummala C. A Phase II Safety and Efficacy Study on Prognosis of Moderate Pneumonia in Coronavirus Disease 2019 Patients With Regular Intravenous Immunoglobulin Therapy.. The Journal of infectious diseases. 2021. DOI: 10.1093/infdis/jiab098.

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