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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Study ID
NCT06577467
Status
Recruiting
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Conditions

  • PASC Post Acute Sequelae of COVID-19

Eligibility Criteria

Sex
ALL
Age
18 Years - 110 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Mar 27, 2025
Status verified
May 2026
Primary completion
Sep 1, 2026
Completion
Sep 1, 2027

Study Design

Enrollment
12 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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

Primary Outcome Measure

To determine where remnants of SARS-CoV-2 virus can be recovered in persons with neuro-PASC and RVs. [ Time Frame: Study End ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
Avindra Nath, M.D.
[email protected]
301-496-1561

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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