Anti-Granulocyte–Macrophage Colony–Stimulating Factor Monoclonal Antibody Gimsilumab for COVID-19 Pneumonia: A Randomized, Double-Blind, Placebo-controlled Trial

Criner, Gerard J.; Lang, Frederick; Gottlieb, Robert L; Mathews, Kusum S.; Wang, Tisha S.; Rice, Todd W.; Madduri, Deepu; Bellam, Shashi; Jeanfreau, Robert; Case, Amy Hajari; Glassberg, Marilyn K.; Lyon, G. Marshall; Ahmad, Kareem; Mendelson, Robert; DiMaio, J. Michael; Tran, MaryAnn P; Spak, Cedric W.; Abbasi, Jamil A; Davis, Steven G; Ghamande, Shekhar; Shen, Steven S.; Sherman, Lisa; Lowry, Simon

doi:10.1164/rccm.202108-1859oc

Cited by 26 publications

(16 citation statements)

References 56 publications

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“…Of note, the studies investigating lenzilumab and mavrilimumab included patients on room air or oxygen by nasal cannula only, whereas the otilimab study did not include these patients and only had patients with high-flow oxygen, non-invasive or invasive ventilation. Last, the recently published BREATHE trial ( 67 ) investigated the use of gimsilumab in hospitalized patients with COVID-19 across the United States. In this double-blind, placebo-controlled, RCT, the primary endpoint was all-cause mortality rate at Day 43.…”

Section: Discussion Of Therapiesmentioning

confidence: 99%

Immunomodulatory therapies for COVID-19

Mathur

Kottilil

2022

Front. Med.

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PurposeAs COVID-19 disease progresses, the host inflammatory response contributes to hypoxemia and severe and critical illness. In these latter stages of disease, patients may benefit from immunomodulatory therapies to control the aberrant host inflammatory response. In this review, we provide an overview of these therapies and provide summaries of the studies that led to issuance of FDA Emergency Use Authorization or recommendation by the Infectious Diseases Society of America (IDSA).Materials and methodsWe reviewed English-language studies, Emergency Use Authorizations (EUAs), and guidelines from March 2020 to present.Conclusion and relevanceThere are several therapies with proposed benefit in severe and critical COVID-19 disease. Few have been issued FDA EUA or recommendation by the Infectious Diseases Society of America (IDSA). Physicians should be familiar with the evidence supporting use of these therapies and the patient populations most likely to benefit from each.

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Section: Discussion Of Therapiesmentioning

confidence: 99%

Immunomodulatory therapies for COVID-19

Mathur

Kottilil

2022

Front. Med.

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“…Some medications (e.g., tocilizumab, otilimab, and mavrilimumab) might be a selection of combination treatment for COVID-19 infection. [ 62 , 63 ]…”

Section: Discussionmentioning

confidence: 99%

Comparative efficacy and safety of pharmacological interventions for severe COVID-19 patients: An updated network meta-analysis of 48 randomized controlled trials

et al. 2022

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Background: To date, there has been little agreement on what drug is the "best" drug for treating severe COVID-19 patients. This study aimed to assess the efficacy and safety of different medications available at present for severe COVID-19. Methods: We searched databases for randomized controlled trials (RCTs) published up to February 28, 2022, with no language restrictions, of medications recommended for patients (aged 16 years or older) with severe COVID-19 infection. We extracted data on trials and patient characteristics, and the following primary outcomes: all-cause mortality (ACM), and treatment-emergent adverse events (TEAEs). Results: We identified 4021 abstracts and of these included 48 RCTs comprising 9147 participants through database searches and other sources. For decrease in ACM, we found that ivermectin/doxycycline, C-IVIG (i.e., a hyperimmune anti-COVID-19 intravenous immunoglobulin), methylprednisolone, interferon-beta/standard-of-care (SOC), interferon-beta-1b, convalescent plasma, remdesivir, lopinavir/ritonavir, immunoglobulin gamma, high dosage sarilumab (HS), auxora, and imatinib were effective when compared with placebo or SOC group. We found that colchicine and interferon-beta/SOC were only associated with the TEAEs of severe COVID-19 patients. Conclusion: This study suggested that ivermectin/doxycycline, C-IVIG, methylprednisolone, interferon-beta/SOC, interferon-beta-1b, convalescent plasma (CP), remdesivir, lopinavir/ritonavir, immunoglobulin gamma, HS, auxora, and imatinib were efficacious for treating severe COVID-19 patients. We found that most medications were safe in treating severe COVID-19. More large-scale RCTs are still needed to confirm the results of this study.

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“…One clinical study was conducted without results on its ability to improve systemic inflammation and mortality in COVID‐19 patients. 378 Otilimab is a human mAb commonly used in RA that blocks the binding of GM‐CSF to the receptor. Currently, otilimab completed one clinical trial (NCT04376684).…”

Section: Intervention Therapymentioning

confidence: 99%

Inflammatory pathways in COVID‐19: Mechanism and therapeutic interventions

Jiang

Zhao

Zhou

et al. 2022

MedComm

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The 2019 coronavirus disease (COVID‐19) pandemic has become a global crisis. In the immunopathogenesis of COVID‐19, SARS‐CoV‐2 infection induces an excessive inflammatory response in patients, causing an inflammatory cytokine storm in severe cases. Cytokine storm leads to acute respiratory distress syndrome, pulmonary and other multiorgan failure, which is an important cause of COVID‐19 progression and even death. Among them, activation of inflammatory pathways is a major factor in generating cytokine storms and causing dysregulated immune responses, which is closely related to the severity of viral infection. Therefore, elucidation of the inflammatory signaling pathway of SARS‐CoV‐2 is important in providing otential therapeutic targets and treatment strategies against COVID‐19. Here, we discuss the major inflammatory pathways in the pathogenesis of COVID‐19, including induction, function, and downstream signaling, as well as existing and potential interventions targeting these cytokines or related signaling pathways. We believe that a comprehensive understanding of the regulatory pathways of COVID‐19 immune dysregulation and inflammation will help develop better clinical therapy strategies to effectively control inflammatory diseases, such as COVID‐19.

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Anti-Granulocyte–Macrophage Colony–Stimulating Factor Monoclonal Antibody Gimsilumab for COVID-19 Pneumonia: A Randomized, Double-Blind, Placebo-controlled Trial

Cited by 26 publications

References 56 publications

Immunomodulatory therapies for COVID-19

Immunomodulatory therapies for COVID-19

Comparative efficacy and safety of pharmacological interventions for severe COVID-19 patients: An updated network meta-analysis of 48 randomized controlled trials

Inflammatory pathways in COVID‐19: Mechanism and therapeutic interventions

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