Cross-Sectional Evaluation of Persistence of SARS-CoV-2 Remnants After Recovery From Acute Infection
NCT Number: NCT06577467
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: PASC Post Acute Sequelae of COVID-19
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-10
Completion Date: 2027-09-01
Locations: National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States

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 4 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.

Primary Outcome Measures: 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., Study End
Secondary Outcome Measures: 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., Study End|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., Study End|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., Study End