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NCT05379478
Immune Responses to COVID-19 Infection or Vaccination
trial testing Laboratory assessment of antibody profiles in COVID-19 in 403 participants. Completed in 1 December 2023.
1 December 2023
Quick facts
| Lead sponsor | Aditxt, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 403 |
| Start date | 1 December 2020 |
| Primary completion | 1 December 2023 |
| Estimated completion | 1 December 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Laboratory assessment of antibody profiles
Conditions studied
- COVID-19 — all drugs for COVID-19 →
Sponsor
Aditxt, Inc.
Who can join
18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The overall purpose of this observational cohort study is to characterize COVID-specific immune responses to SARS-CoV-2 exposure or COVID vaccination in a real-world setting. Participants will be asked to provide blood samples (either a normal venous blood draw, a few drops of blood obtained with a small finger-stick device, or both), as well as saliva or nasal swab sample at a series of visits. Subjects will receive results of the testing that is approved for routine clinical use (i.e., their AditxtScore), while residual samples from each visit will be stored for future testing. These efforts will support ongoing AditxtScore test development and enhance the effectiveness of its interpretation - aiding efforts to maximize benefits of clinical laboratory testing in the pandemic response.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Simultaneous measurement of multiple variant-specific SARS-CoV-2 neutralizing antibodies with a multiplexed flow cytometric assay.
Liu H, Varvel S, Chen G, McConnell J, et al · · 2022 · cited 7× · PMID 36505453 · DOI 10.3389/fimmu.2022.1039163 -
A mathematical model of the within-host kinetics of SARS-CoV-2 neutralizing antibodies following COVID-19 vaccination.
dePillis L, Caffrey R, Chen G, Dela MD, et al · · 2023 · cited 5× · PMID 36202234 · DOI 10.1016/j.jtbi.2022.111280 -
An omicron-specific neutralizing antibody test predicts neutralizing activity against XBB 1.5.
Varvel S, Galdzicka M, Nystrom S, Liu H, et al · · 2024 · PMID 38322270 · DOI 10.3389/fimmu.2024.1334250
Verify or expand the search:
- PubMed search for NCT05379478
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for COVID-19
Currently open trials in the same condition.
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- NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
- NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
- NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
- NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05379478 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Aditxt, Inc.
- Last refreshed: 7 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05379478.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing