COVID-19
Expanded Access Program of Ruxolitinib for the Emergency Treatment of Cytokine Storm From COVID-19 Infection
Incyte Study ID:
INCB 18424-MA-COVID-19-301
CT.gov ID:
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
Clinical Study Purpose
To provide ruxolitinib through an expanded access program for the treatment of cytokine storm due to COVID-19 in the United States to patients who are eligible but not able to be hospitalized or who are hospitalized with a clinical diagnosis and/or positive test for SARD-CoV-2 infection.
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
N/A
DATE
N/A - N/A
TYPE
Expanded Access
PHASE
N/A
SEX
Female & Male
AGE
12+ years
ACCEPTS HEALTHY VOLUNTEERS
Clinical Study Locations
No locations found.
Key Inclusion and Exclusion Criteria
Inclusion Criteria
- Male or female, 12 years of age or older.
- Clinical diagnosis of COVID-19 and/or locally accepted positive test; if feasible, swab should be taken and saved for quantitative testing to determine viral load.
Exclusion Criteria
- Patients, patient's legally authorized representative, or legal guardians unable to review and sign ICF.
- Females who are pregnant or breastfeeding, and males and females who cannot comply with requirements to avoid fathering a child or becoming pregnant.
Protocol Summary
Incyte Study ID:
INCB 18424-MA-COVID-19-301
Primary Purpose:
N/A
Allocation:
N/A
Study Design:
N/A
Masking:
N/A
Interventions:
Drug
Enrollment:
Primary Outcome
Open
Secondary Outcome
Open