meta|Evidence - COVID-19
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immunoglobulin therapy (n=30) vs. placebo (n=29)
randomized controlled trial risk of bias NA
Intravenous immunoglobulin IVIg
Intravenous immunoglobulin IVIg (human) flebogamma 5%: four vials of 5 gm5 daily for 3 consecutive days, in addition to initial treatment.
Placebo
Saline solution. in addition to initial treatment.
Initial treatment including at least both one antiviral and one chloroquine-class drug.
COVID-19 severe or critically
> 18 years of age, PCR-confirmed COVID-19 diagnosis, involvement of > than 30% of both lungs (ground-glass opacity) in high-resolution computed tomography (HRCT) (confirmed by two radiologists), O2 saturation (satO2) of < 90%, and a lack of adequate response to initial treatment including at least both one antiviral and one chloroquine-class drug. Inadequate response to initial treatment was defined as the lack of improvement of dyspnea, fever, and hypoxemia (satO2 less than 90%), as well as the need for oxygenation to maintain satO2 above 90% after 48 h of commencing treatment.
Double-blind.
Single center, Ayatollah Talegani hospital, Iran.
In the registry, main outcome variables were: improvement in o2 saturation , dyspnea, shortening of hospital stay and decreased mortality.
immunoglobulin therapy (n=52) vs. standard of care (n=32)
randomized controlled trial some concerns about risk of bias
Intravenous immunoglobulin
400 mg/kg, IV, daily for 3 days, plus standard of care. All patients in the IVIg group were premedicated with 500 mg Acetaminophen, 100 mg Hydrocortisone, and 25 mg Diphenhydramine 30 min before the injection.
Standard of care.
Hydroxychloroquine 200 mg twice daily plus Lopinavir/Ritonavir 200-50 mg 2 Tab twice daily for 7 days.
Patients in both groups received oxygen and fluid support, lopinavir/ritonavir 200/50 mg, two tablets twice a day, and hydroxychloroquine 200 mg two times daily.
COVID-19 severe or critically
Patients who are diagnosed with COVID-19 by RT-PCR test, who are severely ill, and are between 18 to 65 years old. Patients with oxygen saturation <90% (at rest with nasal cannula 3-4 L/min and FIO2<30-40 L/min) with bilateral pulmonary infiltration. Severe pneumonia cases were determined based on World Health Organization (WHO) case definitions for COVID-19 consisting of the following: respiratory rates: ≥30 breaths/min, SpO2 ≤93%, and PaO2/ FiO2 ≤300 mmHg.
Open-label.
Single center, Dr. Masih Daneshvari Hospital, Tehran, Iran.
immunoglobulin therapy (n=50) vs. standard of care (n=50)
randomized controlled trial some concerns about risk of bias
Intravenous immunoglobulin
Daily IVIg 0.4 g/kg body weight for 5 days, plus standard of care.
Standard of care
Standard of care consisted of Azithromycin; Lopinavir/ritonavir; Piperacillin plus Tazobactam; Acetaminophen and Pantocid.
All patients received standard of care.
COVID-19 severe or critically
Male or female aged ≥18 years with RT-PCR confirmed COVID-19 illness; Patients with 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.
Open-label.
Multicenter, 4 centers across India.
Phase II.
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