NCT06577467 · National Institute of Neurological Disorders and Stroke (NINDS)
Cross-Sectional Evaluation of Persistence of SARS-CoV-2 Remnants After Recovery From Acute Infection
What this study 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.
View original scientific 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 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Recovered Volunteers (RV): Six healthy persons who have recovered from an acute SARS-CoV-2 infection. Inclusion criteria:
- Participants 18 and older
- Ability to provide informed consent
- Completed participation in Phase B of Protocol 000089
- Met 000089 Inclusion criteria for Mild to Moderate COVID-19 without PASC symptoms:
- 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.
- A self-reported illness narrative of recovery to prior health after a SARS/CoV2 infection.
- Laboratory documentation of a positive COVID-19 PCR, NAA, or other EUA Approved test to confirm active COVID infection at the time of the SARS-CoV-2 infection. Participants with positive home tests during Phase A will be required to have a positive anti-SARS nucleocapsid antibody test.
- Meets WHO Clinical Progression Scale of 2 - 6: 2: Ambulatory; symptomatic, independent 3: Ambulatory; symptomatic, assistance needed 4: Hospitalized; no oxygen therapy 5: Hospitalized; oxygen by mask or nasal prongs 6: Hospitalized; oxygen by non-invasive ventilation or high flow oxygen
- Functional Criteria: No substantial symptom severity as determined using SF-36v2: score of \>=85 physical function subscale, and \>=85 on role physical subscale, and \>=85 on social function subscale.
- Determined to be a Healthy Comparator by the 000089 Case Adjudication Committee
- Does not have an active SARS-CoV-2 infection. The protocol will conform with NIH CC standards for documenting a participant does not have active SARS-CoV-2 infection. This may include screening interviews and/or testing. Testing may be repeated with each admission. Participants may be rescreened 6 weeks after acute infection has resolved. Neurologic Post-Acute Sequelae of COVID-19 Participants (Neuro-PASC): Six persons with ongoing neurological complaints following an acute SARS-CoV-2 infection. Inclusion criteria:
- Participants 18 and older
- Ability to provide informed consent
- Completed participation in Phase B of Protocol 000089
- Met 000089 Inclusion criteria for Mild to Moderate COVID-19 with PASC symptoms:
- 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.
- A self-reported illness narrative of the development of persistent PASC symptoms after recovering from a SARS-CoV-2 infection. These include symptoms such as fatigue, cognitive difficulties, orthostatic intolerance, unrefreshing sleep, neuropathic pain, mood change, and post-exertional malaise.
- Laboratory documentation of a positive COVID-19 PCR, NAA, or other EUA Approved test to confirm active COVID infection at the time of the SARS-CoV-2 infection. Participants with positive home tests during Phase A will be required to have a positive anti-SARS nucleocapsid antibody test .
- Meets WHO Clinical Progression Scale of 2 - 6: 2: Ambulatory; symptomatic, independent 3: Ambulatory; symptomatic, assistance needed 4: Hospitalized; no oxygen therapy 5: Hospitalized; oxygen by mask or nasal prongs 6: Hospitalized; oxygen by non-invasive ventilation or high flow oxygen
- Functional Criteria: Substantial symptom severity as determined using SF-36v2: score of \<= 70 physical function subscale, or \<=50 on role physical subscale, or \<=75 on social function subscale.
- Determined to have Post-Acute Sequelae of COVID-19 by the 000089 Case Adjudication Committee
- Primary PASC complaint is neurologic including:
- Neuropathic sensations
- Cognitive complaints
- Postural (Orthostatic) complaints
- Motor complaints
- Does not have an active SARS-CoV-2 infection. The protocol will conform with NIH CC standards for documenting a participant does not have active SARS-CoV-2 infection. This may include screening interviews and/or testing. Testing may be repeated with each admission. Participants may be rescreened 6 weeks after acute infection has resolved.
Exclusion 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 of NIH.
- 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.
Where
- Bethesda, Maryland
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations