COVID-19 Clinical Trial
Official title:
Pathogenesis of BTK-mediated Hyper-Inflammatory Responses in COVID-19
Verified date | February 2022 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 17, 2022 |
Est. primary completion date | February 17, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | - INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Ability to provide informed consent, and 2. Men and women >=18 years of age at the time of signing the informed consent form, and 3. 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 4. 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: 1. Documented history of hemoglobin from most recent blood draw <7g/dL if known. 2. Pregnant or breastfeeding. 3. Any condition that, in the opinion of the investigator, contraindicates participation in this study. |
Country | Name | City | State |
---|---|---|---|
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 |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To characterize the immunologic mechanisms by which BTK inhibition may ameliorate hyper- inflammatory responses in patients with COVID-19. | Inflammatory pathway analyses following BTK inhibition in COVID-19 patients. | day 0, 1,3,7 | |
Secondary | 1. Characterization of TLR3 and TLR7/8-dependent immunologic phenotypes in COVID-19 patients before and after BTK inhibition. | Transcriptomic, genomic, serological and immunologic analyses of response to BTK inhibition therapy in COVID- 19 patients. | day 0, 1,3,7 | |
Secondary | 2. Evaluation of mechanisms of immune cell-specific activation, cytokine production, exhaustion and apoptosis in COVID-19 patients before and after BTK inhibition. | Transcriptomic, genomic, serological and immunologic analyses of response to BTK inhibition therapy in COVID- 19 patients. | day 0, 1,3,7 | |
Secondary | 3. Transcriptional, chromatin, and epigenetic profiling of immune cells at the single cell level in COVID-19 patients before and after BTK inhibition. | Transcriptomic, genomic, serological and immunologic analyses of response to BTK inhibition therapy in COVID- 19 patients. | day 0, 1,3,7 | |
Secondary | 4. Longitudinal evaluation of TCR and BCR repertoire development in COVID-19 patients before and after BTK inhibition. | Transcriptomic, genomic, serological and immunologic analyses of response to BTK inhibition therapy in COVID- 19 patients. | day 0, 1,3,7 | |
Secondary | 5. Characterization of SARS- CoV-2 serological responses in COVID-19 patients with and without BTK inhibition. | Transcriptomic, genomic, serological and immunologic analyses of response to BTK inhibition therapy in COVID- 19 patients. | day 0, 1,3,7 | |
Secondary | 6. Characterization of genetic variants that correlate with disease severity and/or response to BTK inhibition treatment. | Transcriptomic, genomic, serological and immunologic analyses of response to BTK inhibition therapy in COVID- 19 patients. | day 0, 1,3,7 | |
Secondary | 7. Evaluation of soluble biomarkers as surrogate markers of hyper- inflammation/prognosis and of response to BTK inhibition therapy in COVID-19 patients | Transcriptomic, genomic, serological and immunologic analyses of response to BTK inhibition therapy in COVID- 19 patients. | day 0, 1,3,7 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06065033 -
Exercise Interventions in Post-acute Sequelae of Covid-19
|
N/A | |
Completed |
NCT06267534 -
Mindfulness-based Mobile Applications Program
|
N/A | |
Completed |
NCT05047601 -
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
|
Phase 2/Phase 3 | |
Recruiting |
NCT05323760 -
Functional Capacity in Patients Post Mild COVID-19
|
N/A | |
Recruiting |
NCT04481633 -
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
|
N/A | |
Completed |
NCT04537949 -
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
|
Phase 1/Phase 2 | |
Completed |
NCT04612972 -
Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru
|
Phase 3 | |
Recruiting |
NCT05494424 -
Cognitive Rehabilitation in Post-COVID-19 Condition
|
N/A | |
Active, not recruiting |
NCT06039449 -
A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2
|
Phase 3 | |
Enrolling by invitation |
NCT05589376 -
You and Me Healthy
|
||
Completed |
NCT05158816 -
Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
|
||
Recruiting |
NCT04341506 -
Non-contact ECG Sensor System for COVID19
|
||
Completed |
NCT04512079 -
FREEDOM COVID-19 Anticoagulation Strategy
|
Phase 4 | |
Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT05975060 -
A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT05542862 -
Booster Study of SpikoGen COVID-19 Vaccine
|
Phase 3 | |
Withdrawn |
NCT05621967 -
Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
|
N/A | |
Terminated |
NCT05487040 -
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
|
Phase 1 | |
Terminated |
NCT04498273 -
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
|
Phase 3 | |
Active, not recruiting |
NCT06033560 -
The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure
|