ArticleEClinicalMedicine2021
Hyperimmune anti-COVID-19 IVIG (C-IVIG) treatment in severe and critical COVID-19 patients: A phase I/II randomized control trial.
Article in EClinicalMedicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 9 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
37 citing papers in PubMed, 9 syntheses or guidelines pooled it, 55 citations in OpenAlex.
- Intravenous immunoglobulin for treatment of hospitalized COVID-19 patients: an evidence mapping and meta-analysis.Inflammopharmacology · 2024Pooled it
- Pooled it
- Hyperimmune immunoglobulin for people with COVID-19.The Cochrane database of systematic reviews · 2023Pooled it
- Benefits of high-dose intravenous immunoglobulin on mortality in patients with severe COVID-19: An updated systematic review and meta-analysis.Frontiers in immunology · 2023Pooled it
- Intravenous immunoglobulin (IVIg) therapy in hospitalised adult COVID-19 patients: A systematic review and meta-analysis.Reviews in medical virology · 2022Pooled it
- Controversies about immunoglobulin replacement therapy in HSCT recipients with hypogammaglobulinemia.Bone marrow transplantation · 2022Pooled it
- The efficiency of convalescent plasma in COVID-19 patients: A systematic review and meta-analysis of randomized controlled clinical trials.Frontiers in immunology · 2022Pooled it
- Antibody and cellular therapies for treatment of covid-19: a living systematic review and network meta-analysis.BMJ (Clinical research ed.) · 2021Pooled it
- Efficacy of COVID-19 Treatments: A Bayesian Network Meta-Analysis of Randomized Controlled Trials.Frontiers in public health · 2021Pooled it
- A Randomized Controlled Study Assessing Convalescent Immunoglobulins vs Convalescent Plasma for Hospitalized Patients With Coronavirus 2019.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Trial
- Nucleocapsid-specific antibody function is associated with therapeutic benefits from COVID-19 convalescent plasma therapy.Cell reports. Medicine · 2022Trial
- Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial.Lancet (London, England) · 2022Trial
- On the Use of Immunoglobulins for Pre-exposure Prophylaxis Against COVID-19 in Immunocompromised Patients.Infection and drug resistance · 2026Review
- Effect of intravenous immunoglobulin on mortality in hospitalized patients with COVID-19: A systematic review and meta-analysis of randomized controlled trials.Health science reports · 2024Article
- Hyperimmune Plasma and Immunoglobulins against COVID-19: A Narrative Review.Life (Basel, Switzerland) · 2024Review
- Passive antibody therapy in emerging infectious diseases.Frontiers of medicine · 2023Review
- Review
- Rates Among Hospitalized Patients With COVID-19 Treated With Convalescent Plasma: A Systematic Review and Meta-Analysis.Mayo Clinic proceedings. Innovations, quality & outcomes · 2023Article
- Subcutaneous anti-COVID-19 hyperimmune immunoglobulin for prevention of disease in asymptomatic individuals with SARS-CoV-2 infection: a double-blind, placebo-controlled, randomised clinical trial.EClinicalMedicine · 2023Article
- Review of therapeutic mechanisms and applications based on SARS-CoV-2 neutralizing antibodies.Frontiers in microbiology · 2023Review
Corrections and comments
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Authors and funding
23 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHyperimmune anti-COVID-19 Intravenous Immunoglobulin (C-IVIG) is an unexplored therapy amidst the rapidly evolving spectrum of medical therapies for COVID-19 and is expected to counter the three most life-threatening consequences of COVID-19 including lung injury by the virus, cytokine storm and sepsis.
methodsA single center, phase I/II, randomized controlled, single-blinded trial was conducted at Dow University of Health Sciences, Karachi, Pakistan. Participants were COVID-19 infected individuals, classified as either severely or critically ill with Acute Respiratory Distress Syndrome (ARDS). Participants were randomized through parallel-group design with sequential assignment in a 4:1 allocation to either intervention group with four C-IVIG dosage arms (0.15, 0.20, 0.25, 0.30 g/kg), or control group receiving standard of care only (
findingsFifty participants were enrolled in the study from June 19, 2020 to February 3, 2021 with a mean age of 56.54±13.2 years of which 22 patients (44%) had severe and 28 patients (56%) had critical COVID-19. Mortality occurred in ten of 40 participants (25%) in intervention group compared to six of ten (60%) in control group, with relative risk reduction in intervention arm I (RR, 0.333; 95% CI, 0.087-1.272), arm II (RR, 0.5; 95% CI, 0.171-1.463), arm III (RR, 0.167; 95% CI, 0.024-1.145), and arm IV (RR, 0.667; 95% CI, 0.268-1.660). In intervention group, median HI significantly improved to 359 mmHg [interquartile range (IQR) 127-400,
interpretationAdministration of C-IVIG in severe and critical COVID-19 patients was safe, increased the chance of survival and reduced the risk of disease progression.
fundingHigher Education Commission (HEC), Pakistan (Ref no. 20-RRG-134/RGM/R&D/HEC/2020).
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Registered trials
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