Status:
WITHDRAWN
Pathogenesis of BTK-mediated Hyper-Inflammatory Responses in COVID-19 (RESPOND)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Brief Summary
Background: Coronavirus disease 2019 (COVID-19) is an acute respiratory syndrome. It is caused by the SARS-CoV-2 virus. People with severe COVID-19 infection have a hyper-inflammatory response. Bruto...
Detailed Description
Coronavirus disease 2019 (COVID-19) is an acute respiratory syndrome caused by the novel coronavirus severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Severe COVID-19 infection is associat...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Ability to provide informed consent, and
- Men and women \>=18 years of age at the time of signing the informed consent form, and
- Diagnosis of COVID-19 in hospitalized patients with hypoxemia (SpO2 less than or equal to 94% on room air), with plan to receive or not receive BTK inhibition for clinical or for external research study purposes, or
- Does not have COVID-19 and does have plan to receive BTK inhibition therapy for a clinical indication other than COVID-19 (either hospitalized or not).
- EXCLUSION CRITERIA:
- Individuals meeting any of the following criteria will be excluded from study participation:
- Documented history of hemoglobin from most recent blood draw \<7g/dL if known.
- Pregnant or breastfeeding.
- Any condition that, in the opinion of the investigator, contraindicates participation in this study.
Exclusion
Key Trial Info
Start Date :
February 17 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 17 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04394884
Start Date
February 17 2022
End Date
February 17 2022
Last Update
February 24 2022
Active Locations (3)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
2
Walter Reed National Medical Center
Bethesda, Maryland, United States, 20301
3
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892