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

Description

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.

Conditions

PASC Post Acute Sequelae of COVID-19

Study Overview

Study Details

Study overview

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.

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

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

Condition
PASC Post Acute Sequelae of COVID-19
Intervention / Treatment

-

Contacts and Locations

Bethesda

National Institutes of Health Clinical Center, Bethesda, Maryland, United States, 20892

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Current suicidal ideation
  • * Women who are pregnant, breastfeeding, or are within one-year post-partum.
  • * Current or previous malignancy. 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 autoimmune thyroid disease) and allergic disorders will be allowed.
  • * Current or previous long-term immune suppressive therapy. Systemic steroid 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 at NIH that are under the direct supervision of the study investigators.
  • * 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.

Ages Eligible for Study

18 Years to 110 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

National Institute of Neurological Disorders and Stroke (NINDS),

Avindra Nath, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Neurological Disorders and Stroke (NINDS)

Study Record Dates

2027-09-01