ClinicalTrials.gg
RecruitingNCT06577467Updated Sep 16, 2026

Cross-Sectional Evaluation of Persistence of SARS-CoV-2 Remnants After Recovery From Acute Infection

An observational study in PASC Post Acute Sequelae of COVID-19, sponsored by National Institute of Neurological Disorders and Stroke (NINDS). Recruiting at 1 site in United States. Open to participants aged 18 Years to 110 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by National Institute of Neurological Disorders and Stroke (NINDS) · Observational

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 7 months later.

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Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
12
Ages
18 Years to 110 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 194 studies in Post-Acute COVID-19 Syndrome with a site in United States — 62 open to participants now, 84 under way, 7 of them phase 3. Post-Acute COVID-19 Syndrome · United States.

Planned enrollment
34th of 37
12 · median 155
Started
2025
with 28 others
Observational
37 of 194
15 open now
Primary completion
2027-09
later than 54 of 83 live
Registered
148th of 194
by date

Among the 194 studies in Post-Acute COVID-19 Syndrome with a site in United States, this one is the 34th largest by planned enrollment of the 37 observational ones that give a count, is one of 29 that started in 2025, is one of 37 observational ones, reaches primary completion later than 54 of the 83 other live ones, and was the 148th registered.

Post-Acute COVID-19 Syndrome

605 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 201 are open to participants now.

Browse Post-Acute COVID-19 Syndrome studies →

Open to participants now

62 of the 194 studies in Post-Acute COVID-19 Syndrome with a site in United States are open now. Recruiting first, the newest first:

56 more — sign in →

All 62 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 145 Post-Acute COVID-19 Syndrome studies recruiting now, 70 (48%) set no upper age limit and 53 (37%) stop at 75 or younger; 15 take children under 18; 39 take healthy volunteers.

This study: 18 Years to 110 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 194 studies in Post-Acute COVID-19 Syndrome with a site in United States, or all of them as a file.
02

Study summary

Background:

SARS-CoV-2 is the virus that causes COVID-19. Some people who recover from COVID-19 have symptoms that last long after the active infection ends. This is called "long COVID." Sometimes, long COVID can affect the nerves and cause problems with sleep, thinking, the senses, and movement. Researchers want to find out whether people with long COVID have retained inactive remnants of SARS-CoV-2 in their bodies.

Objective:

To collect tissue samples to see if people with long COVID have remnants of SARS-CoV-2 in their bodies.

Eligibility:

People 18 years or older who have recovered from COVID-19, both with and without neurologic symptoms.

Design:

Participants will have 2 to 6 inpatient or outpatient visits over 4 months. Each visit will last 4 to 5 days.

Participants will be screened to make sure it is safe to collect tissue samples from their body. They will have a physical and dental exam. They will have imaging scans and a test of their heart function. They will complete questionnaires about their health. They will give blood, urine, saliva, and stool samples. Their sense of taste and smell will be tested.

Tissue samples will be taken from the digestive tract, lungs, colon, skin, muscle, lymph nodes, nasal passages, and mouth. Participants may be numbed or sedated for some of the procedures.

Swabs will be used to collect cells from inside the mouth and nose.

Participants will undergo lumbar puncture. A thin needle will be inserted into their lower back to draw out a sample of the fluid around their spinal cord.

Participants will have follow-up phone calls after each clinic visit.

Read the detailed description

Study Description:

It has been demonstrated that remnants of the SARS-CoV-2 virus remain after the resolution of the acute infective period. It is not known if these viral remnants interact with host tissues in the development and maintenance of the Post-Acute Sequelae of COVID-19 (PASC)/Long COVID. Better understanding of how to recover and characterize SARS-CoV-2 viral remnants from humans is a valuable first step in understanding the health impact that they may have on humans. This study will focus on the recovery and characterization of SARS-CoV-2 remnants from multiple organ sites of individual volunteers with persistent neurological complications from SARS-CoV-2 (Neuro-PASC) and volunteers those who have recovered from a SARS-CoV-2 infection (RV).

Objectives:

  • Primary Objective:

    --To determine where remnants of SARS-CoV-2 virus can be recovered in persons with neuro-PASC and RVs.

  • Secondary Objectives:

    • To characterize the biochemical nature of SARS-CoV-2 recovered viral remnants (e.g. proteins, nucleic acids).
    • To determine if there are quantitative differences in recovered SARS-CoV-2 proteins between neuro-PASC and RV participants.
    • To determine if there are quantitative differences in recovered SARS-CoV-2 nucleic acids between neuro-PASC and RV participants.

Endpoints:

This is an exploratory cross-sectional protocol to determine whether the presence or absence of viral remnants can be detected in a range of human tissues. Hence, tissue-specific detection of viral remnants is the primary end point. Secondary endpoints will characterize and quantify the recovered remnants to allow group comparisons between neuro-PASC and RV participants.

03

Conditions studied

  • PASC Post Acute Sequelae of COVID-19

Keywords

  • PASC
  • COVID-19
04

Who can participate

Ages eligible
18 Years to 110 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

6 neuro-PASC patients with: 1. Neurologic and neuropsychiatric complaint is the primary clinical issue. 2. Neuro-PASC clinical symptom burden is moderate or greater. 3. Other PASC complications, such as pulmonary, cardiovascular, or gastrointestinal symptoms, are not prominent case features. 6 Recovered volunteers with: 1. Reports no ongoing or new health issues attributable to a SARS-CoV-2 infection 2. Overall clinical symptoms burden is no greater than mild 3. No clinically substantial comorbid medical or psychiatric conditions

Eligibility criteria

  • INCLUSION CRITERIA:

Recovered Volunteers (RV): Six healthy persons who have recovered from an acute SARS-CoV-2 infection.

Inclusion criteria:

  • Participants 18 and older
  • Ability to provide
  • Completed participation in Phase B of Protocol 000089
  • Met 000089 Inclusion criteria for Mild to Moderate COVID-19 without PASC symptoms:

    • Licensed Independent Practitioner documentation of a stable state of general well-health and physical function prior to contracting SARS-CoV-2. This may include medical records, correspondence letters, or information gathered from telephone calls with study personnel.
    • A self-reported illness narrative of recovery to prior health after a SARS/CoV2 infection.
    • Laboratory documentation of a positive COVID-19 PCR, NAA, or other EUA Approved test to confirm active COVID infection at the time of the SARS-CoV-2 infection. Participants with positive home tests during Phase A will be required to have a positive anti-SARS nucleocapsid antibody test.
    • Meets WHO Clinical Progression Scale of 2 - 6:

      2: Ambulatory; symptomatic, independent

      3: Ambulatory; symptomatic, assistance needed

      4: Hospitalized; no oxygen therapy

      5: Hospitalized; oxygen by mask or nasal prongs

      6: Hospitalized; oxygen by non-invasive ventilation or high flow oxygen

    • Functional Criteria: No substantial symptom severity as determined using SF-36v2: score of >=85 physical function subscale, and >=85 on role physical subscale, and >=85 on social function subscale.
  • Determined to be a Healthy Comparator by the 000089 Case Adjudication Committee
  • Does not have an active SARS-CoV-2 infection. The protocol will conform with NIH CC standards for documenting a participant does not have active SARS-CoV-2 infection. This may include screening interviews and/or testing. Testing may be repeated with each admission. Participants may be rescreened 6 weeks after acute infection has resolved.

Neurologic Post-Acute Sequelae of COVID-19 Participants (Neuro-PASC):

Six persons with ongoing neurological complaints following an acute SARS-CoV-2 infection.

Inclusion criteria:

  • Participants 18 and older
  • Ability to provide informed consent
  • Completed participation in Phase B of Protocol 000089
  • Met 000089 Inclusion criteria for Mild to Moderate COVID-19 with PASC symptoms:

    • Licensed Independent Practitioner documentation of a stable state of general well-health and physical function prior to contracting SARS-CoV-2. This may include medical records, correspondence letters, or information gathered from telephone calls with study personnel.
    • A self-reported illness narrative of the development of persistent PASC symptoms after recovering from a SARS-CoV-2 infection. These include symptoms such as fatigue, cognitive difficulties, orthostatic intolerance, unrefreshing sleep, neuropathic pain, mood change, and post-exertional malaise.
    • Laboratory documentation of a positive COVID-19 PCR, NAA, or other EUA Approved test to confirm active COVID infection at the time of the SARS-CoV-2 infection. Participants with positive home tests during Phase A will be required to have a positive anti-SARS nucleocapsid antibody test .
    • Meets WHO Clinical Progression Scale of 2 - 6:

      2: Ambulatory; symptomatic, independent

      3: Ambulatory; symptomatic, assistance needed

      4: Hospitalized; no oxygen therapy

      5: Hospitalized; oxygen by mask or nasal prongs

      6: Hospitalized; oxygen by non-invasive ventilation or high flow oxygen

    • Functional Criteria: Substantial symptom severity as determined using SF-36v2: score of \<= 70 physical function subscale, or \<=50 on role physical subscale, or \<=75 on social function subscale.
  • Determined to have Post-Acute Sequelae of COVID-19 by the 000089 Case Adjudication Committee
  • Primary PASC complaint is neurologic including:

    • Neuropathic sensations
    • Cognitive complaints
    • Postural (Orthostatic) complaints
    • Motor complaints
  • Does not have an active SARS-CoV-2 infection. The protocol will conform with NIH CC standards for documenting a participant does not have active SARS-CoV-2 infection. This may include screening interviews and/or testing. Testing may be repeated with each admission. Participants may be rescreened 6 weeks after acute infection has resolved.

EXCLUSION CRITERIA:

  • Current suicidal ideation
  • Women who are pregnant, breastfeeding, or are within one-year post-partum.
  • Current or previous . A history of malignancy that has fully resolved with surgical resection only (e.g. no chemotherapy, radiation therapy, or immunotherapy) will be allowed.
  • Current systemic immunologic disorders (e.g. Type 1 diabetes, rheumatoid arthritis). Local immunological disorder (e.g. atopic dermatitis, stable thyroid disease) and allergic disorders will be allowed.
  • Current or previous long-term immune suppressive therapy. Systemic use, even short-term, must not have been used within the month prior to enrollment.
  • Long term use of anticoagulant or antiplatelet medications.
  • Active participation in a clinical protocol (e.g. anti-inflammatory drug intervention study) which includes an intervention that may affect the results of the current study.
  • Not willing to allow for research data and samples to be shared broadly with other researchers.
  • Employees of NIH.
  • Symptom severity that makes it impossible for the volunteer to travel to NIH for an extended inpatient evaluation
  • Use of medications with a high-risk for withdrawal-related complications (i.e. long-acting opiates or benzodiazepines).
  • Unwillingness to co-enroll in protocol 17-I-0122: NIAID Centralized Sequencing Protocol.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
12 participants (estimated)

Groups and cohorts

  • Neuro-PASC

    1.\<TAB\>Neurologic and neuropsychiatric complaint is the primary clinical issue. 2.\<TAB\>Neuro-PASC clinical symptom burden is moderate or greater.3.\<TAB\>Other PASC complications, such as pulmonary, cardiovascular, or gastrointestinal symptoms, are not prominent case features.

  • Recovered volunteers

    1.\<TAB\>Reports no ongoing or new health issues attributable to a SARS-CoV-2 infection2.\<TAB\>Overall clinical symptoms burden is no greater than mild3.\<TAB\>No clinically substantial comorbid medical or psychiatric conditions

06

What researchers measure

Primary outcomes

  1. To determine where remnants of SARS-CoV-2 virus can be recovered in persons with neuro-PASC and RVs.

    This is an exploratory study to determine where SARS-CoV-2 viral remnants can be recovered in tissues of patients with Neuro-PASC.

    Time frame: Study End

Secondary outcomes

  1. 1.To characterize the biochemical nature of SARS-CoV-2 recovered viral remnants (e.g. proteins, nucleic acids).PASC and RV participants.

    If defective or restricted viral replication is present in the tissues, one might not detect fully replicating virus or all viral components. It is not known if SARS-CoV-2 proteins or RNA preferentially resides in particular tissue types.

    Time frame: Study End

  2. 2.To determine if there are quantitative differences in recovered SARS-CoV-2 proteins between neuro-PASC and RV participants.

    If defective or restricted viral replication is present in the tissues, one might not detect fully replicating virus or all viral components. It is not known if SARS-CoV-2 proteins or RNA preferentially resides in particular tissue types.

    Time frame: Study End

  3. 3.To determine if there are quantitative differences in recovered SARS-CoV-2 nucleic acids between neuro-PASC and RV participants.

    If defective or restricted viral replication is present in the tissues, one might not detect fully replicating virus or all viral components. It is not known if SARS-CoV-2 proteins or RNA preferentially resides in particular tissue types.

    Time frame: Study End

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — All collected IPD will be shared that underlie results in a publication.

Supporting information: Study protocol, Informed consent form

Time frame: At time of publication

Access criteria: Creative commons-BY

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2025 (actual). Primary completion is estimated for Sep 2027, 29 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 28, 2024
First posted
Aug 29, 2024
StartActual
Mar 27, 2025
Primary completionEst.
Sep 1, 2027
CompletionEst.
Sep 1, 2027
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06577467
Responsible party
Sponsor
First posted
Aug 29, 2024
Start date
Mar 27, 2025
Primary completion
Sep 1, 2027 (estimated)
Completion
Sep 1, 2027 (estimated)
Last update
Sep 16, 2026

Study contacts

Cynthia L Vierria
Contact
cynthia.vierria@nih.gov
(301) 594-6760
Avindra Nath, M.D.
Contact
natha@mail.nih.gov
(301) 496-1561
Avindra Nath, M.D.
principal investigator · National Institute of Neurological Disorders and Stroke (NINDS)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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