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

NCT04486521 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 860

Last updated 2021-03-08

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Interleukin 6 (IL6) Antagonist

anti-IL6 alone

DRUG

Interleukin 6 (IL6) Antagonist and corticosteroids

anti-IL6 + corticosteroid combination

DRUG

corticosteroid alone

dexamethasone, hydrocortisone, methylprednisolone, prednisone. All steroids " other than dexamethasone" will be converted to dexamethasone equivalent

Sponsors & Collaborators

  • Society of Critical Care Medicine

    collaborator OTHER

  • King Faisal Specialist Hospital & Research Center

    lead OTHER

Principal Investigators

  • Marwa Amer, PharmD,BCPS, BCCCP · King Faisal Specialist Hospital and Research Center- Riyadh

  • Mohammed Bawazeer, MD,FRCSC,FACS · King Faisal Specialist Hospital and Research Center- Riyadh

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-22
Primary Completion
2021-07-22
Completion
2021-07-22
FDA Drug
Yes

Countries

  • Saudi Arabia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04486521 on ClinicalTrials.gov