Intravenous immunoglobulins in patients with COVID-19-associated moderate-to-severe acute respiratory distress syndrome (ICAR): multicentre, double-blind, placebo-controlled, phase 3 trial

Mazeraud, Aurélien; Jamme, Matthieu; Mancusi, Rossella Letizia; Latroche, Claire; Mégarbane, Bruno; Siami, Shidasp; Zarka, Jonathan; Moneger, Guy; Santoli, F.; Argaud, Laurent; Chillet, Patrick; Muller, Grégoire; Bruel, Cédric; Asfar, Pierre; Beloncle, François; Reignier, Jean; Vinsonneau, Christophe; Schimpf, Caroline; Amour, Julien; Goulenok, Cyril; Lemaître, Caroline; Rohaut, Benjamin; Mateu, Philippe; Rudnicki, S. de; Mourvillier, Bruno; Declercq, Pierre-Louis; Schwebel, Carole; Stoclin, Annabelle; Garnier, Marc; Madeux, Benjamin; Gaudry, Stéphane; Bailly, Karine; Lamer, Christian; Aegerter, Philippe; Rieu, C.; Sylla, Khaoussou; Lucas, Bruno; Sharshar, Tarek

doi:10.1016/s2213-2600(21)00440-9

Cited by 46 publications

(62 citation statements)

References 37 publications

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“…Previous studies utilizing IVIG treatment for COVID-19 infections have given mixed results. Retrospective studies have largely been positive, yet prospective clinical trials have been mixed, with some favorable results [ 5 , 15 , 16 ] and a more recent study showing no benefit [ 17 ]. However, considerable debate still exists that some subgroups of COVID-19 patients may benefit from IVIG that are diluted by broad clinical trials which lack granularity among the heterogeneity of patient characteristics and timing of IVIG administration [ 18 , 19 ].…”

Section: Discussionmentioning

confidence: 99%

Case Series of Successful Intravenous Immunoglobulin (IVIG) Treatment in 4 Pregnant Patients with Severe COVID-19-Induced Hypoxia

et al. 2022

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Case series Patients: Female, 34-year-old • Female, 31-year-old • Female, 29-year-old • Female, 24-year-old Final Diagnosis: SARS-CoV-2 Symptoms: Hypoxia Medication: Intravenous immunoglobulin Clinical Procedure: — Specialty: Infectious Diseases Objective: Rare disease Background: Despite unprecedented speed in the execution of the COVID-19 vaccine and therapeutic clinical trials, pregnant patients have been largely excluded from initial studies. In addition, pregnant patients who are unvaccinated against SARS-CoV-2 have greater morbidity risk with severe COVID-19 disease as compared to patients of similar age and comorbidity status. Intravenous immunoglobulin (IVIG) has been deemed safe in pregnancy in other diseases. Prior data demonstrate the possible benefit of utilizing IVIG for the treatment in hospitalized patients with severe respiratory symptoms associated with COVID-19 active infections when administered within 14 days of COVID symptom onset. Case Reports: We administered IVIG (Privigen ® , CSL Behring) 0.5 g/kg daily for 3 consecutive days to 4 pregnant patients (ages 24-34 years of age) who were hospitalized with moderate-to-severe COVID-19 and not vaccinated against SARS-CoV-2. All patients received concomitant glucocorticoid therapy. Gestational ages were 26, 17, 35, and 35 weeks. All patients were discharged home breathing room air after a mean hospital stay of 15 days. Two patients had uncomplicated cesarean section at 35 weeks during the hospitalization. The pre-term pregnancies at 17 and 26 weeks were intact at hospital discharge and resulted in normal vaginal deliveries at term. All 4 patients consented to participate in this case series report. Conclusions: IVIG may be a safe treatment consideration in pregnant women with severe COVID-19 to avoid pregnancy complications. Its use warrants further study in pregnancy acute respiratory distress syndrome (ARDS) due to SARS-CoV-2, influenza, and other respiratory viruses to which pregnant patients are vulnerable.

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Section: Discussionmentioning

confidence: 99%

Case Series of Successful Intravenous Immunoglobulin (IVIG) Treatment in 4 Pregnant Patients with Severe COVID-19-Induced Hypoxia

et al. 2022

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“…In the recent ICAR RCT, IVIG was tried in patients with COVID-19 who received invasive mechanical ventilation for moderate-to-severe ARDS. In these patients, IVIG did not improve clinical outcomes at day 28 (76). The effect of IVIG on earlier disease stages of COVID-19 is currently being assessed (77).…”

Section: Repurposing Of Antirheumatic Drugs For the Treatment Of Seve...mentioning

confidence: 91%

“…In these patients, IVIG did not improve clinical outcomes at day 28 (Ref. 76). The effect of IVIG on earlier disease stages of COVID-19 is currently being assessed (Ref.…”

Section: Repurposing Of Antirheumatic Drugs For the Treatment Of Seve...mentioning

confidence: 99%

COVID-19: autoimmunity, multisystemic inflammation and autoimmune rheumatic patients

Szekanecz

Balog

Constantin

et al. 2022

Expert Rev. Mol. Med.

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Coronavirus disease 2019 (COVID-19) is associated with autoimmunity and systemic inflammation. Patients with autoimmune rheumatic and musculoskeletal disease (RMD) may be at high risk for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. In this review, based on evidence from the literature, as well as international scientific recommendations, we review the relationships between COVID-19, autoimmunity and patients with autoimmune RMDs, as well as the basics of a multisystemic inflammatory syndrome associated with COVID-19. We discuss the repurposing of pharmaceutics used to treat RMDs, the principles for the treatment of patients with autoimmune RMDs during the pandemic and the main aspects of vaccination against SARS-CoV-2 in autoimmune RMD patients.

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“…Shao et al showed IVIG from normal human plasma reduced mortality rate at day 28 in patients with critical COVID-19 ( P = 0.014) [ 26 ]. However, phase 3 trial of IVIG for patients with COVID-19-associated acute respiratory distress syndrome did not prolong ventilation-free days by day 28 as the primary endpoint ( P = 0.21) [ 27 ]. To expect more powerful action for SARS-CoV-2, hyperimmune anti-COVID-19 IVIG (C-IVIG) is under investigation [ 28 ].…”

Section: Clinical Data Of Igrt In Non-hsct Setting Including Covid-19mentioning

confidence: 99%

Controversies about immunoglobulin replacement therapy in HSCT recipients with hypogammaglobulinemia

Ohmoto

Fuji

Shultes

et al. 2022

Bone Marrow Transplant

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The efficacy of immunoglobulin replacement therapy (IgRT) has been demonstrated for primary immune deficiency diseases and hematological malignancies such as chronic lymphocytic leukemia (CLL) or multiple myeloma with hypogammaglobulinemia. Clinical development of anti-B cell therapies including a monoclonal antibody, bispecific antibody, or chimeric antigen receptor T-cell therapy which could result in severe hypogammaglobulinemia accelerates the argument of prophylactic use of IgRT. Clinical guidelines for CLL describe immunoglobulin administration in patients with a low IgG who have experienced a severe/repeated bacterial infection. The utility in hematopoietic stem-cell transplantation (HSCT) remains unknown. Although an early randomized trial demonstrated that IgRT decreased infection risk and transplant-related mortality after HSCT, subsequent clinical trials could not validate the benefit. Consequently, a meta-analysis did not show the benefit of IgRT in HSCT. Most of the available data derives from matched-related HSCT using myeloablative regimen, and the impact in haploidentical and cord blood transplantation, or reduced-intensity HSCT remains unknown. One crucial issue is that no studies exist for patients with only hypogammaglobulinemia after HSCT. Other challenges are heterogeneous patient characteristics, or immunoglobulin formulation, dosage, schedule, route and duration of IgRT. Without evidence in HSCT, it would be reasonable to follow the guidelines for other diseases with hypogammaglobulinemia.

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Intravenous immunoglobulins in patients with COVID-19-associated moderate-to-severe acute respiratory distress syndrome (ICAR): multicentre, double-blind, placebo-controlled, phase 3 trial

Cited by 46 publications

References 37 publications

Case Series of Successful Intravenous Immunoglobulin (IVIG) Treatment in 4 Pregnant Patients with Severe COVID-19-Induced Hypoxia

Case Series of Successful Intravenous Immunoglobulin (IVIG) Treatment in 4 Pregnant Patients with Severe COVID-19-Induced Hypoxia

COVID-19: autoimmunity, multisystemic inflammation and autoimmune rheumatic patients

Controversies about immunoglobulin replacement therapy in HSCT recipients with hypogammaglobulinemia

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