FindMyKOL
Clinical trialNCT04394884WithdrawnObservational

Pathogenesis of BTK-mediated Hyper-Inflammatory Responses in COVID-19 (RESPOND)

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment0COVID-19
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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. Bruton tyrosine kinase (BTK) plays a role in the innate immune system. BTK inhibition can be used to target the innate immune system that appears to contribute to mortality. This could be an effective way to help the inflammatory responses in people with COVID-19. Objective: To learn more about the immunologic mechanisms by which BTK inhibition may decrease hyper-inflammatory responses in people with COVID-19. Eligibility: People ages 18 and older in one of the following groups: * They are in the hospital with COVID-19. They will or will not be treated with a BTK inhibitor. * They do not have COVID-19. They are or are not in the hospital. They will be treated with a BTK inhibitor for a reason other than COVID-19. Design: Participants will be screened with a review of their demographic and clinical information. Their medical history will be reviewed. If they have COVID-19, their symptoms will be assessed. Participants will give 3-4 blood samples. These may be taken through a vein. They may also be taken through an existing central venous catheter. Participants may give a stool sample. This will be collected by nursing staff. It will be collected using a stool collection vial. Stool collection is optional. Participants samples will be collected over about 7 days. These will be used for research and genetic testing.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • Michail S Lionakis, M.D.

    National Institute of Allergy and Infectious Diseases (NIAID)

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

3 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Johns Hopkins Hospital

    Baltimore, Maryland, United States

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, United States

  • Walter Reed National Medical Center

    Bethesda, Maryland, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
17 Feb 2022
Primary completion
17 Feb 2022
Completion
17 Feb 2022
Last update posted
24 Feb 2022
Registered enrollment
0
Registry id
NCT04394884

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.