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Clinical Trial 20622

Cancer Type: Multiple
Study Type: Other
NCT#:

Phase: N/A
Prinicipal Investigator: Kedar Kirtane

Call 813-745-6100
or 1-800-679-0775 Learn More
Overview

Study Title

REACT COVID-19: Real world Evidence for Anti-Cytokine Therapy in COVID-19, an International, Multi-center, Observational Study

Summary

This is an international, multicenter, observational study to collect clinical data and correlative biomarkers inpatients with suspected or confirmed COVID-19 who have been or will be treated with anti-cytokine therapy. Data will be used to assess relationships between previously administered anti-cytokine therapies, clinical outcomes, resource utilization, and serial changes in cytokine profiles and other correlative biomarkers. This protocol will not specify any therapeutic interventions and is an observational study to collect clinical and correlative data only.

Objective

This is an international, multi-center, observational study to collect clinical data and correlative biomarkers in patients with suspected or confirmed COVID-19 who have been or will be treated with anti-cytokine therapy. Data will be used to assess relationships between previously administered anti-cytokine therapies, clinical outcomes, resource utilization, and serial changes in cytokine profiles and other correlative biomarkers. This protocol will not specify any therapeutic interventions and is an observational study to collect clinical and correlative data only.

Treatments

Therapies

Medications

Inclusion Criteria

  • Prospective Cohort > Adult >18 years of age at time of enrollment
  • Positive test result for COVID-19 or diagnostic test pending for COVID-19 and have a suspected illness, meeting definition of existing institutional definition of COVID-19 illness (or provided definition in appendix 1 if no institutional definition exists)
  • Intent to anti-cytokine therapy or patient has received anti-cytokine therapy ≤24 hrs prior to enrollment. Note: Anti-cytokine therapy includes: anti-IL6 therapy (tocilizumab, siltuximab, or sarilumab),anti-IL1 therapy (anakinra), or anti- TNF-Alpha therapy (infliximab, adalimumab, certolizumab-pegol, golimumab, or etanercept
  • Retrospective Cohort
  • Adult >18 years of age at time of enrollment
  • Positive test result for COVID-19 or diagnostic test pending for COVID-19 and have a suspected illness, meeting definition of existing institutional definition of COVID-19 illness (or provided definition in appendix 1 if no institutional definition exists)
  • Documented administration of anti-cytokine therapy for COVID-19 illness at any time prior to enrollment. Note: Anti-cytokine therapy includes: anti-IL6 therapy (tocilizumab, siltuximab, or sarilumab), anti-IL1 therapy (anakinra), or anti- TNF-Alpha therapy (infliximab, adalimumab, certolizumab-pegol, golimumab, or etanercept)

  • Exclusion Criteria

  • Patient receiving treatment outside of a hospital setting
  • Patients on existing chronic anti-cytokine therapy specifically treatment of underlying rheumatologic, dermatologic, or gastrointestinal disorder
  • Patients receiving anti-cytokine therapy on a prospective clinical trial where the anti-cytokine is the defined therapeutic intervention under study for COVID19 patients will not be eligible

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.