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NCT04734678

Comparison of Tocilizumab Versus Tocilizumab/Infliximab in Patients With COVID-19-associated Cytokine Storm Syndrome

Completed Last updated 20 July 2022
What this trial tests

trial testing Tocilizumab in Covid19 in 153 participants. Completed in 1 August 2021.

Timeline
1 December 2020
Primary endpoint
1 June 2021
1 August 2021

Quick facts

Lead sponsorAin Shams University
StatusCompleted
Study typeOBSERVATIONAL
Enrollment153
Start date1 December 2020
Primary completion1 June 2021
Estimated completion1 August 2021
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Ain Shams University

Who can join

Adults 18 to 65, any sex, with Covid19 or Cytokine Storm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Since the end of 2019, Egypt and the whole world have been suffering from the Coronavirus Disease 2019 (COVID-19) pandemic, which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). According to the World Health Organization (WHO), since the emergence of this new pandemic, there have been more than 97 million confirmed cases of COVID-19 patients and two million death globally; around 160 thousand of these cases are in Egypt. Tocilizumab play role among the unique therapeutic alternatives for the management of cytokine release syndrome (CRS), a life-threatening complication of chimeric antigen receptor (CAR) - T cell therapy. CRS occurs as a result of uncontrolled immune activation with release of pro-inflammatory cytokines and chemokines. Up till now, clinical trial and expertise with tocilizumab in COVID-19 patients has been limited. Despite preliminary encouraging results, recent studies suffered from limitations such as the absence of consistent treatment outline, a short post-treatment follow-up, and the absence of a comparison group. A recent study discussed the possible beneficial effect of tumor necrosis factor (TNF) inhibitors in severe COVID-19. Specifically, TNF may aggravate lymphopenia through direct killing via TNF/TNFR1 signaling in T cells, and T cell dysfunction reveals an important yet underestimated target for immunomodulatory therapeutic approaches. Accordingly, anti-TNF may be considered as an encouraging therapeutic option in severe COVID-19. These promising clinical findings encouraged us to use infliximab (IFX), a chimeric monoclonal anti-TNF antibody, as an experimental therapy in patients with moderate and severe COVID-19 in the absence of IBD. In this study, we compare the outcomes of a large cohort of patients with moderate and severe COVID-19 pneumonia treated with tocilizumab in addition to standard management, with those of concomitantly hospitalized patients who received infliximab and tocilizumab in addition to standard management.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The signal pathways and treatment of cytokine storm in COVID-19.
    Yang L, Xie X, Tu Z, Fu J, et al · · 2021 · cited 444× · PMID 34234112 · DOI 10.1038/s41392-021-00679-0
  2. Monoclonal antibodies for COVID-19 therapy and SARS-CoV-2 detection.
    Hwang YC, Lu RM, Su SC, Chiang PY, et al · · 2022 · cited 170× · PMID 34983527 · DOI 10.1186/s12929-021-00784-w
  3. Targeting TNF-α for COVID-19: Recent Advanced and Controversies.
    Guo Y, Hu K, Li Y, Lu C, et al · · 2022 · cited 104× · PMID 35223745 · DOI 10.3389/fpubh.2022.833967
  4. The mechanism underlying extrapulmonary complications of the coronavirus disease 2019 and its therapeutic implication.
    Ning Q, Wu D, Wang X, Xi D, et al · · 2022 · cited 64× · PMID 35197452 · DOI 10.1038/s41392-022-00907-1
  5. Inflammatory pathways in COVID-19: Mechanism and therapeutic interventions.
    Jiang Y, Zhao T, Zhou X, Xiang Y, et al · · 2022 · cited 44× · PMID 35923762 · DOI 10.1002/mco2.154
  6. Cytokine Storm Syndrome in SARS-CoV-2 Infections: A Functional Role of Mast Cells.
    Hafezi B, Chan L, Knapp JP, Karimi N, et al · · 2021 · cited 41× · PMID 34359931 · DOI 10.3390/cells10071761
  7. Immune responses in mildly versus critically ill COVID-19 patients.
    Nasrollahi H, Talepoor AG, Saleh Z, Eshkevar Vakili M, et al · · 2023 · cited 35× · PMID 36793739 · DOI 10.3389/fimmu.2023.1077236
  8. Passive Immunotherapy Against SARS-CoV-2: From Plasma-Based Therapy to Single Potent Antibodies in the Race to Stay Ahead of the Variants.
    Strohl WR, Ku Z, An Z, Carroll SF, et al · · 2022 · cited 31× · PMID 35476216 · DOI 10.1007/s40259-022-00529-7

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