Status:
RECRUITING
Cross-Sectional Evaluation of Persistence of SARS-CoV-2 Remnants After Recovery From Acute Infection
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
PASC Post Acute Sequelae of COVID-19
Eligibility:
All Genders
18-110 years
Brief 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, lon...
Detailed Description
Study Description: It has been demonstrated that remnants of the SARS-CoV-2 virus remain after the resolution of the acute infective period. It is not known if these viral remnants interact with host...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 27 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06577467
Start Date
March 27 2025
End Date
September 1 2027
Last Update
November 28 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892