SARS-CoV InfectionNCT05313087
COVID-19 Vaccine Response in Chronic Respiratory Conditions
An observational study of SARS-CoV Infection, run by National Jewish Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV Infection
- What is being tested?
- COVID-19 vaccine
- Type of treatment
- Vaccines
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2021to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with chronic medical conditions seen at our medical center (National Jewish Health)
Who may be able to join
- Receipt of a SARS-CoV-2 vaccination
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
HYPOTHESES
- 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.
- 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
- 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.
- 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) .
- Categorize patients by their age, gender, race, ethnicity, underlying chronic disease, disease severity, medical therapy and comorbidities.
- Assess the clinical effectiveness of the vaccine to prevent COVID-19 infections.
- 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:
- Controls - who are NOT in any of the groups listed below.
- Previous COVID infection
- Asthma receiving immunomodulator medications
- Asthma receiving chronic oral steroids
- Asthma - NOT receiving immunomodulator medications or chronic oral steroids
- Chronic Obstructive Pulmonary Disease (COPD)
- Rheumatoid Arthritis receiving immunomodulator medications
- Rheumatoid Arthritis NOT receiving immunomodulator medications
- Interstitial lung disease
- Cancer patients receiving chemotherapy
- Bronchiectasis
- Cystic fibrosis
- Conditions
- SARS-CoV Infection
- Being tested
- COVID-19 vaccine
- Medical subject headings
- Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 vaccineBiological
assess response to vaccine
| Study group | Role | What they receive |
|---|---|---|
| Controls - who are NOT in any of the groups listed below | Adults and children age 5 and over. Receives: Biological: COVID-19 vaccine | |
| Previous COVID infection | Adults and children age 5 and over. Receives: Biological: COVID-19 vaccine | |
| Asthma receiving immunomodulator medications | Adults and children age 5 and over. Receives: Biological: COVID-19 vaccine | |
| Asthma receiving chronic oral steroids | Adults and children age 5 and over. Receives: Biological: COVID-19 vaccine | |
| Asthma - NOT receiving immunomodulator medications or chronic oral steroids | Adults and children age 5 and over. Receives: Biological: COVID-19 vaccine | |
| Chronic Obstructive Pulmonary Disease (COPD | Adults Receives: Biological: COVID-19 vaccine | |
| Rheumatoid Arthritis receiving immunomodulator medications | Adults and children age 5 and over. Receives: Biological: COVID-19 vaccine | |
| Rheumatoid Arthritis NOT receiving immunomodulator medications | Adults and children age 5 and over. Receives: Biological: COVID-19 vaccine | |
| Interstitial lung disease | Adults and children age 5 and over. Receives: Biological: COVID-19 vaccine | |
| Cancer patients receiving chemotherapy | Adults and children age 5 and over. Receives: Biological: COVID-19 vaccine | |
| Bronchiectasis | Adults and children age 5 and over. Receives: Biological: COVID-19 vaccine | |
| Cystic fibrosis | Adults and children age 5 and over. Receives: Biological: COVID-19 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody response
quantitative spike protein antibody, binding antibody units (BAU)
Measured: after SARS-CoV-2 vaccinations
Secondary outcomes (5)
Antibody change
Quantitative spike protein antibody, binding antibody units (BAU)
Measured: Change 3 months after vaccinations
Antibody change
Quantitative spike protein antibody, binding antibody units (BAU)
Measured: Change 6 months after vaccinations
Antibody change
Quantitative spike protein antibody, binding antibody units (BAU)
Measured: Change 9 months after vaccinations
Antibody change
Quantitative spike protein antibody, binding antibody units (BAU)
Measured: Change 12 months after vaccinations
Antibody change
Quantitative spike protein antibody, binding antibody units (BAU)
Measured: Change 18 months after vaccinations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start3 Feb 2021
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barry Make, National Jewish Health
- Investigators
- Barry Make, MD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313087
- Sponsor's protocol ID
- 21-08-054-528
- Status last verified
- Apr 2026
- First submitted
- 1 Jun 2021
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results will be shared once the study results are analyzed and published.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Vaccine Response and Durability In Patients With Chronic Respiratory and Medical Disorders
- ClinicalTrials.gov ID
- NCT05313087
- Acronym / sponsor ID
- 21-08-054-528
- Conditions
- SARS-CoV Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
HYPOTHESES
- 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.
- 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
- 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.
- 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) .
- Categorize patients by their age, gender, race, ethnicity, underlying chronic disease, disease severity, medical therapy and comorbidities.
- Assess the clinical effectiveness of the vaccine to prevent COVID-19 infections.
- 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:
- Controls - who are NOT in any of the groups listed below.
- Previous COVID infection
- Asthma receiving immunomodulator medications
- Asthma receiving chronic oral steroids
- Asthma - NOT receiving immunomodulator medications or chronic oral steroids
- Chronic Obstructive Pulmonary Disease (COPD)
- Rheumatoid Arthritis receiving immunomodulator medications
- Rheumatoid Arthritis NOT receiving immunomodulator medications
- Interstitial lung disease
- Cancer patients receiving chemotherapy
- Bronchiectasis
- Cystic fibrosis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Controls - who are NOT in any of the groups listed below | – | Biological: COVID-19 vaccineAdults and children age 5 and over. |
| Previous COVID infection | – | Biological: COVID-19 vaccineAdults and children age 5 and over. |
| Asthma receiving immunomodulator medications | – | Biological: COVID-19 vaccineAdults and children age 5 and over. |
| Asthma receiving chronic oral steroids | – | Biological: COVID-19 vaccineAdults and children age 5 and over. |
| Asthma - NOT receiving immunomodulator medications or chronic oral steroids | – | Biological: COVID-19 vaccineAdults and children age 5 and over. |
| Chronic Obstructive Pulmonary Disease (COPD | – | Biological: COVID-19 vaccineAdults |
| Rheumatoid Arthritis receiving immunomodulator medications | – | Biological: COVID-19 vaccineAdults and children age 5 and over. |
| Rheumatoid Arthritis NOT receiving immunomodulator medications | – | Biological: COVID-19 vaccineAdults and children age 5 and over. |
| Interstitial lung disease | – | Biological: COVID-19 vaccineAdults and children age 5 and over. |
| Cancer patients receiving chemotherapy | – | Biological: COVID-19 vaccineAdults and children age 5 and over. |
| Bronchiectasis | – | Biological: COVID-19 vaccineAdults and children age 5 and over. |
| Cystic fibrosis | – | Biological: COVID-19 vaccineAdults and children age 5 and over. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic medical conditions seen at our medical center (National Jewish Health)
Key inclusion criteria (1 listed)
- Receipt of a SARS-CoV-2 vaccination
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 vaccineassess response to vaccine | Biological | Asthma - NOT receiving immunomodulator medications or chronic oral steroids, Asthma receiving chronic oral steroids, Asthma receiving immunomodulator medications, Bronchiectasis, Cancer patients receiving chemotherapy, Chronic Obstructive Pulmonary Disease (COPD, Controls - who are NOT in any of the groups listed below, Cystic fibrosis, Interstitial lung disease, Previous COVID infection, Rheumatoid Arthritis NOT receiving immunomodulator medications, Rheumatoid Arthritis receiving immunomodulator medications |
Primary outcome
Antibody response
Time frame: after SARS-CoV-2 vaccinations
quantitative spike protein antibody, binding antibody units (BAU)
5 secondary outcomes
Antibody change
Time frame: Change 3 months after vaccinations
Antibody change
Time frame: Change 6 months after vaccinations
Antibody change
Time frame: Change 9 months after vaccinations
Antibody change
Time frame: Change 12 months after vaccinations
Antibody change
Time frame: Change 18 months after vaccinations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Yes. Results will be shared once the study results are analyzed and published.
Related trials for SARS-CoV Infection
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Not yet recruiting
Effect of MxA Guidance on Antiviral Treatment in Respiratory Viral Infections
Respiratory Viral Infections, Influenza
Recruiting
Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.
COVID-19, Long COVID
Active, not recruiting
SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel Following mRNA COVID-19 Vaccination
SARS-CoV Infection
Active, not recruiting
Clinical Validation of the NowFuture Digital Flu / COVID Test in Anterior Nasal Samples for Over-the-Counter (OTC) Use in Australia
SARS CoV 2 Infection, Influenza A Virus Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry Make, MD principal investigator
National Jewish Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV Infection, run by National Jewish Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody response (time frame: after SARS-CoV-2 vaccinations). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.