NCT04486521

Anti-IL6 and Corticosteroid Monotherapy vs Combination in COVID-19

Status unknown Last updated 8 March 2021

What this trial tests

trial testing Interleukin 6 (IL6) Antagonist in Critical Illness in 860 participants. Status unknown.

Timeline

22 July 2020

Primary endpoint
22 July 2021

22 July 2021

Quick facts

Lead sponsor	King Faisal Specialist Hospital & Research Center
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	860
Start date	22 July 2020
Primary completion	22 July 2021
Estimated completion	22 July 2021
Sites	1 location across Saudi Arabia

Drugs / interventions tested

• Interleukin 6 (IL6) Antagonist — full drug profile →
• Interleukin 6 (IL6) Antagonist and corticosteroids — full drug profile →
• corticosteroid alone — full drug profile →

Conditions studied

• Critical Illness — all drugs for Critical Illness →
• Corona Virus Infection — all drugs for Corona Virus Infection →
• Cytokine Release Syndrome — all drugs for Cytokine Release Syndrome →

Sponsor

King Faisal Specialist Hospital & Research Center

Who can join

14 and older, any sex, with Critical Illness or Corona Virus Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The cytokine storms mediated by over production of proinflammatory cytokines have been observed in a large population of critically ill patients infected with COVID-19. Patients diagnosed with cytokine storms progress to cardiovascular collapse, multiple organ dysfunction and death rapidly. Therefore, early identification, treatment and prevention of the cytokine storms are of crucial importance for the patients. Immuomedulator such as interleukin-6 (IL-6) antagonist, emerged as an alternative treatment for COVID-19 patients with a risk of cytokine storms recently. In this study, we aimed to evaluate the safety and efficacy of anti-IL6 alone vs anti-IL6 corticosteroid combination in patients with COVID-19 pneumonia

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 429× · PMID 34234112 · DOI 10.1038/s41392-021-00679-0
2. Current Strategies of Antiviral Drug Discovery for COVID-19.
   Mei M, Tan X. · · 2021 · cited 76× · PMID 34055887 · DOI 10.3389/fmolb.2021.671263
3. Cytokine Storms in Cancer and COVID-19.
   Turnquist C, Ryan BM, Horikawa I, Harris BT, et al · · 2020 · cited 68× · PMID 33038939 · DOI 10.1016/j.ccell.2020.09.019
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. Association of COVID-19 with Comorbidities: An Update.
   Chatterjee S, Nalla LV, Sharma M, Sharma N, et al · · 2023 · cited 60× · PMID 36923110 · DOI 10.1021/acsptsci.2c00181
6. The intersection of COVID-19 and cancer: signaling pathways and treatment implications.
   Zong Z, Wei Y, Ren J, Zhang L, et al · · 2021 · cited 54× · PMID 34001144 · DOI 10.1186/s12943-021-01363-1
7. Corticosteroids for COVID-19 Therapy: Potential Implications on Tuberculosis.
   Gopalaswamy R, Subbian S. · · 2021 · cited 52× · PMID 33917321 · DOI 10.3390/ijms22073773
8. 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