NCT04401436

COVID-19 Associated Lymphopenia Pathogenesis Study in Blood

Completed Last updated 27 October 2025

What this trial tests

trial in Coronavirus Disease 2019 in 240 participants. Completed in 24 February 2025.

Timeline

22 May 2020

Primary endpoint
20 February 2025

24 February 2025

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	240
Start date	22 May 2020
Primary completion	20 February 2025
Estimated completion	24 February 2025
Sites	3 locations across United States

Conditions studied

• Coronavirus Disease 2019 — all drugs for Coronavirus Disease 2019 →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 99, any sex, with Coronavirus Disease 2019. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

COVID-19 is an acute respiratory syndrome. One symptom of COVID-19 is a reduction in the number of cells called lymphocytes in the blood. Lymphocytes are a type of white blood cell that fights infections. With fewer lymphocytes, the body cannot effectively fight back against SARS CoV-2, the virus that causes COVID-19. Researchers want to better understand how SARS-CoV-2 affects these blood cells. This information may give them ideas for new treatments.

Objective:

To learn more about how SARS-CoV-2 affects lymphocytes, the immune, and the blood clotting system.

Eligibility:

Adults age 18 and older who either currently have COVID-19 or have recently recovered from it

Design:

Participants will give a blood sample. For this, a needle is used to collect blood from an arm vein. For participants who have a central line, blood will be collected through that instead.

Participants medical records related to COVID-19 will be reviewed.

Participants who have recovered from COVID-19 will be asked to undergo leukapheresis to collect white blood cells. For this, blood is taken from a needle placed in one arm. A machine separates out the white blood cells. The rest of the blood is returned to the participant through a needle placed in the other arm. This takes about 2-3 hours.

Recovered participants may have material collected from inside the nostrils and/or rectum. This is done by gently rubbing the area with a sterile cotton swab.

Recovered participants may have an echocardiogram to look at their heart. For this, a small probe is held against the chest to get pictures of the heart from different angles. This takes less than 30 minutes.

Participation lasts 1-2 days on most cases and may be split in a few visits for recovered patients if leukapheresis and echocardiogram are done.

...

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. T-cell responses and therapies against SARS-CoV-2 infection.
   Toor SM, Saleh R, Sasidharan Nair V, Taha RZ, et al · · 2021 · cited 158× · PMID 32935333 · DOI 10.1111/imm.13262
2. Persistent Oxidative Stress and Inflammasome Activation in CD14^highCD16^- Monocytes From COVID-19 Patients.
   Lage SL, Amaral EP, Hilligan KL, Laidlaw E, et al · · 2021 · cited 69× · PMID 35095880 · DOI 10.3389/fimmu.2021.799558
3. Clinical, Virologic, and Immunologic Evaluation of Symptomatic Coronavirus Disease 2019 Rebound Following Nirmatrelvir/Ritonavir Treatment.
   Epling BP, Rocco JM, Boswell KL, Laidlaw E, et al · · 2023 · cited 51× · PMID 36200701 · DOI 10.1093/cid/ciac663
4. Activation of Complement Components on Circulating Blood Monocytes From COVID-19 Patients.
   Lage SL, Rocco JM, Laidlaw E, Rupert A, et al · · 2022 · cited 19× · PMID 35250994 · DOI 10.3389/fimmu.2022.815833
5. Coronavirus disease 2019 rebounds following nirmatrelvir/ritonavir treatment.
   Lai CC, Hsueh PR. · · 2023 · cited 17× · PMID 36571273 · DOI 10.1002/jmv.28430
6. SARS-CoV-2 infection perturbs the gastrointestinal tract and induces modest microbial translocation across the intestinal barrier.
   Brooks K, Nelson CE, Aguilar C, Hoang TN, et al · · 2024 · cited 8× · PMID 39264207 · DOI 10.1128/jvi.01288-24
7. Immune responses to SARS-CoV-2 mRNA vaccination in people with idiopathic CD4 lymphopenia.
   Rocco JM, Boswell KL, Laidlaw E, Epling B, et al · · 2024 · cited 4× · PMID 38344971 · DOI 10.1016/j.jaci.2023.10.012
8. Prevalence of anti-lymphocyte IgM autoantibodies driving complement activation in COVID-19 patients.
   Pérez-Díez A, Liu X, Calderon S, Bennett A, et al · · 2024 · cited 2× · PMID 38694513 · DOI 10.3389/fimmu.2024.1352330