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.
Participants 18 and older
Ability to provide informed consent
Completed participation in Phase B of Protocol 000089
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.
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.
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
Case-control
Cross-sectional
Not listed
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.
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.
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.
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.
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