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Identification and Characterization of SARS-CoV-2 Specific CD8 T Cells in Humans

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 300 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Dec 31, 2025 to Dec 31, 2026v300
  2. 4 versions Re-verified since Jan 22, 2025, no change to tracked fieldsv296-v299
  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 120 to confirmed 83 · Site details revisedv295 Show 2 more changesShow less
    • Enrollment target: estimated 120 to confirmed 83
    • Site details revised
  4. 6 versions Re-verified since Mar 9, 2024, no change to tracked fieldsv289-v294
  5. Completion date: Dec 31, 2025 to Sep 30, 2027v288
Show 37 earlier versionsHide 37 earlier versions
  1. 3 versions Re-verified since Oct 29, 2022, no change to tracked fieldsv285-v287
  2. Site contact updatedv284
  3. 18 versions Re-verified since Jun 8, 2022, no change to tracked fieldsv266-v283
  4. Primary and study completion dates: Sep 20, 2022 to Dec 31, 2025v265
  5. 14 versions Re-verified since May 16, 2022, no change to tracked fieldsv251-v264
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: The higher death rate from COVID-19 in the older population is associated with low CD8 T cell counts in the blood. Researchers want to learn the status of CD8 T cells specific to SARS-CoV-2 and their changes with aging and in COVID-19. This may help to identify why COVID-19 is particularly lethal in the elderly and help to create an effective vaccine against SARS-CoV-2 in the elderly. Objective: To identify SARS-CoV-2 specific CD8 T cells in humans, and to determine their quantity and quality in people who have recovered from COVID-19. Eligibility: Maryland residents age 18 and older who have tested positive for and recovered from COVID-19. Design: Participants will be screened by phone. They must be able to provide a copy of their positive COVID-19 test result. Participants will visit the NIA/Clinical Research Unit. The visit will take about 1 hour. Laboratory tests showing a positive COVID-19 result will be verified. Participants vital signs will be checked. This will include blood pressure, temperature, pulse, and respiration. Height and weight will be measured. Participants will have a medical history and medicine review. They will complete a COVID-19 questionnaire. Participants will have blood drawn. They will give a urine sample. Participants will give a saliva sample. They will rinse their mouth with water. After about 3 minutes, they will let saliva pool in the base of their mouth and then spit into a sterile container. Participants may be asked if they would be willing to return for optional visits at about 4 months and 1 year later. They will repeat the same laboratory sampling performed at the first visit. ...
Trial Details
NCT Number NCT04565067
Lead Sponsor National Institute on Aging (NIA)
Conditions COVID-19
Enrollment 83 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov