SARS-CoV Infection Clinical Trial
Official title:
COVID-19 Vaccine Response and Durability In Patients With Chronic Respiratory and Medical Disorders
The investigators will assess the antibody, T cell and B cell responses to SARS-CoV-2 vaccination before and every 3 months for 18 months after the initial vaccination or subsequent vaccinations (boosters) in adults and children including patients with chronic medical conditions.
HYPOTHESES 1. Patients with chronic respiratory diseases will have a lower antibody response to SARS-CoV-2 virus after vaccination and shorter durability of the response than control subjects without chronic disorders. 2. Patients on corticosteroids and other immunomodulator medications for chronic medical disorders will have a lower antibody response to SARS-CoV-2 after vaccination and shorter durability of the response than subjects with chronic disorders who are not being treated with corticosteroids and immunomodulator medications. SPECIFIC AIMS 1. Enroll up to 1,000 patients receiving a SARS-CoV-2 vaccination (initial or subsequent vaccinations) in an observational study to determine vaccine antibody response and durability. 1. Obtain blood samples to measure antibody assess the antibody, T cell and B cell responses to SARS-CoV-2 vaccination before and every 3 months for 18 months after the initial vaccination or subsequent vaccinations (boosters) . 2. Categorize patients by their age, gender, race, ethnicity, underlying chronic disease, disease severity, medical therapy and comorbidities. 3. Assess the clinical effectiveness of the vaccine to prevent COVID-19 infections. 3. Determine the clinical features and gene expression of patients who are less responsive (have lower antibody levels and shorter duration of antibody response) to SARS-CoV-2 vaccinations. STUDY DESIGN Patient population - up to 1,000. Consisting of patients in the following groups: 1. Controls - who are NOT in any of the groups listed below. 2. Previous COVID infection 3. Asthma receiving immunomodulator medications 4. Asthma receiving chronic oral steroids 5. Asthma - NOT receiving immunomodulator medications or chronic oral steroids 6. Chronic Obstructive Pulmonary Disease (COPD) 7. Rheumatoid Arthritis receiving immunomodulator medications 8. Rheumatoid Arthritis NOT receiving immunomodulator medications 9. Interstitial lung disease 10. Cancer patients receiving chemotherapy 11. Bronchiectasis 12. Cystic fibrosis ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04961541 -
Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04546776 -
COVID-19 Persistence in Stool
|
||
| Terminated |
NCT04542993 -
Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy
|
Phase 2 | |
| Completed |
NCT04542915 -
COVID-19-Related Health and Practices Among Dental Hygienists
|
||
| Completed |
NCT05065827 -
Lung Ultrasound Findings in Patients With COVID-19 in a UK ED
|
||
| Recruiting |
NCT04615052 -
Home-based Exercise in COVID-19 Survivors
|
N/A | |
| Enrolling by invitation |
NCT04659486 -
Adolescents With COVID-19/MIS-C at HCFMUSP
|
N/A | |
| Recruiting |
NCT04885452 -
Prevention of COVID-19 Complications in High-risk Subjects Infected by SARS-CoV-2 and Eligible for Treatment Under a Cohort ATU ('Autorisation Temporaire d'Utilisation') OR or Authorisation for Early Access (AAP). A Prospectvie Cohort.
|
||
| Completed |
NCT05063812 -
Performance of a Remote Monitoring Program for Patients Diagnosed With COVID-19
|
||
| Completed |
NCT04516928 -
Study of SARS-CoV2 Virus (COVID-19) Seroprevalence Among Lyon-Bron Military Health Schools Personnel
|
||
| Completed |
NCT04530357 -
Reactogenicity, Safety and Immunogenicity of QazCovid-in® COVID-19 Vaccine
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04565782 -
Corona Virus Infection Among Liver Transplant Recipients
|
||
| Completed |
NCT04550390 -
Study of the Analytical Performance of Different Salivary Self-collection Methods for the Detection of COVID-19
|
||
| Completed |
NCT04733625 -
The Effect of Vitamin D Therapy on Morbidity and Moratlity in Patients With SARS-CoV 2 Infection
|
N/A | |
| Active, not recruiting |
NCT04517136 -
Impact of Perceived Control on Operational Strain: a Study of COVID-19 Pandemic Caregivers and Military Personnel on Operational Missions
|
||
| Recruiting |
NCT04476680 -
Influence of Military Preventive Policy for reCruit Training on COVID-19 Seroconversion
|
N/A | |
| Completed |
NCT04514874 -
Assessment of the Prevalence and the Impact of the COVID-19 Epidemic in the French Flight Crew in 2020
|
||
| Completed |
NCT04839913 -
Seroprevalence of SARS-CoV-2 in Unselected Surgical Patients: an Unicentric, Regional Study
|
||
| Terminated |
NCT04606563 -
Host Response Mediators in Coronavirus (COVID-19) Infection - Is There a Protective Effect of Losartan and Other ARBs on Outcomes of Coronavirus Infection?
|
Phase 3 | |
| Completed |
NCT05234359 -
The CHILD Cohort COVID-19 Add-On Study
|