Actively Recruiting

Age: 18Years - 110Years
All Genders
Healthy Volunteers
NCT06577467

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

Led by National Institute of Neurological Disorders and Stroke (NINDS) · Updated on 2026-04-17

12

Participants Needed

1

Research Sites

126 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 110Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years or older
  • Ability to provide informed consent
  • Completed participation in Phase B of Protocol 000089
  • For recovered volunteers: documentation of stable health before COVID-19 infection
  • Self-reported full recovery to prior health after COVID-19 infection
  • Laboratory confirmation of positive COVID-19 test at time of infection or positive antibody test if home test was used
  • WHO Clinical Progression Scale score between 2 and 6 during infection
  • Functional criteria of good physical and social function (SF-36v2 scores ≥85)
  • Determined healthy comparator by Case Adjudication Committee
  • No active SARS-CoV-2 infection
  • For Neuro-PASC participants: documentation of stable health before COVID-19 infection
  • Self-reported persistent neurological symptoms after COVID-19 including fatigue, cognitive issues, orthostatic intolerance, unrefreshing sleep, neuropathic pain, mood changes, post-exertional malaise
  • Laboratory confirmation of positive COVID-19 test at time of infection or positive antibody test if home test was used
  • WHO Clinical Progression Scale score between 2 and 6 during infection
  • Functional criteria of substantial symptom severity (SF-36v2 scores ≤70 physical function, ≤50 role physical, or ≤75 social function)
  • Determined to have Post-Acute Sequelae of COVID-19 by Case Adjudication Committee
  • Primary neurological symptoms including neuropathic sensations, cognitive complaints, postural complaints, or motor complaints
  • No active SARS-CoV-2 infection
Not Eligible

You will not qualify if you...

  • Current suicidal thoughts
  • Women who are pregnant, breastfeeding, or within one year postpartum
  • Current or previous cancer unless fully resolved by surgery alone
  • Current systemic immune disorders (e.g., type 1 diabetes, rheumatoid arthritis)
  • Current or past long-term immune suppressive therapy or recent systemic steroid use
  • Long-term use of blood thinners
  • Participation in other clinical trials with interventions affecting this study
  • Unwillingness to share research data and samples broadly
  • Employees of NIH
  • Symptom severity preventing travel to NIH for extended evaluation
  • Use of medications with high risk for withdrawal complications (e.g., long-acting opiates or benzodiazepines)
  • Unwillingness to co-enroll in specific related protocols

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

A

Angelique A Gavin

CONTACT

A

Avindra Nath, M.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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