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

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).

Antibody and cellular therapies for treatment of covid-19: a living systematic review and network meta-analysis

“…After screening 52350 titles and abstracts and 1029 full texts, 47 unique randomised controlled trials that evaluated antiviral antibody or cellular treatments were identified as of 21 July 2021 (fig 1). 43444546474849505152535455565758596061626364656667686970717273747576777879808182838485868788 A table of excluded full texts is provided in the supplementary data on bmj.com. Searches of living evidence retrieval services identified 11 publications of eligible randomised trials, which were reconciled with our formal search strategy when necessary 222324254549566466676875838688.…”

Efficacy of COVID-19 Treatments: A Bayesian Network Meta-Analysis of Randomized Controlled Trials

“…Overall, 115 studies with 77,128 patients reported the number of patients requiring mechanical ventilation during the study period. We included ACEIs/ARBs, ammonium chloride, azithromycin, bamlanivimab, baricitinib plus remdesivir, bromhexine, budesonide, camostat mesilate, canakinumab, chloroquine, colchicine, convalescent plasma, dexamethasone, doxycycline, favipiravir, hydroxychloroquine, hydroxychloroquine plus azithromycin, hydroxychloroquine plus favipiravir, imatinib, INM005, interferon beta, intravenous immunoglobulin, ivermectin, lopinavir/ritonavir, methylprednisolone, recombinant human GCSF, remdesivir, sarilumab, sofosbuvir plus daclatasvir, sulodexide, tocilizumab, tofacitinib, vitamin D3 and SOC as treatment nodes in the NMA, for which observations came from 84 studies ( 3 , 6 , 22 – 26 , 28 – 31 , 35 , 42 , 43 , 46 , 47 , 50 , 53 , 55 , 57 – 61 , 63 , 64 , 66 , 67 , 71 , 73 – 77 , 79 , 80 , 82 , 83 , 85 – 87 , 89 , 92 – 94 , 96 – 100 , 102 , 105 – 107 , 109 , 111 – 118 , 120 – 124 , 126 , 128 – 132 , 134 , 135 , 139 , 140 , 145 , 151 , 152 , 154 – 156 ). About one-third (26/84) of the included studies were evaluated as low risk ( Supplementary Table 6 ).…”

Therapeutic Agents Rounding Up the Immunopathology of COVID-19

“…An open-label, multicenter, comparative, randomized study found that duration of hospital stay was significantly shorter in IVIG group than that of standard care alone (7.7 vs.17.5 days). 70 Duration for normalization of body temperature, oxygen saturation and mechanical ventilation were significantly shorter in IVIG compared to standard care. However, a retrospective study for non-severe patients with COVID-19 reported that no statistically significant differences were found between IVIG group and control group in the duration of fever (median, 3 vs 3 days, p = 0.667), virus clearance time (median, 11 vs.10 days, p = 0.288), length of hospital stay (median, 14 vs 13 days, p = 0.469), and the use of antibiotics (40% vs 38.9%, p = 0.901).…”

“…6, 2020), n=96 100 mg twice a day for 3d 100 mg daily for 7 days Admission to the ICU for IMV or death Anakinra group: 13 of 52 (25%) Historical group: 32 of 44 (73%) Canakinumab Landi L et al, 2020, 65 Italy Prospective cohort study (30d), n=88 300 mg sc Median PaO2/FiO2 Median duration of hospitalization Death at 7 days Overall survival at 1 month From 160 at baseline to 237 6d 12 of 88 (13.6%) 79.5% Canakinumab Generali D et al, 2020, 66 Italy Prospective case-control study (01–25 Apr. 2020), n=48 150mg on day 1 and day 7 Survival rate at 60 days Canakinumab: 90.0% Control: 73.3% IVIG Xie Y et al, 2020, 68 China Retrospective study (Jan. to Feb. 2020), n=58 20 g/day 28-day mortality ≤48 h group 7 of 30 (23.3%) >48 h group 16 of 28 (57.1%) (p = 0.009) IVIG Infliximab Farrokhpour M et al, 2021, 69 Iran Cohort study (Mar, 2020), n=104 IVIG: 400mg/kg/d for 3 to 5 days Infliximab: a single dose of 5 mg/kg Death IVIG: 6 of 23(26.1%) Infliximab: 10 of 27(37%) Combination Therapy: 5 of 11(45.5%) vs Control: 27 of 43(62.8%) (all P < 0.05) IVIG R S R et al, 2021, 70 India Phase-II RCT (Jul. to Sept., 2020), n=100 0.4g/kg/d for 5 days Number of days of hospitalization IVIG: 7.72 vs Control: 17.5 (p < 0.01) IVIG Huang C et al, 2021, 71 China …”