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Cross-Sectional Evaluation of Persistence of SARS-CoV-2 Remnants After Recovery From Acute Infection
NCT06577467 · National Institutes of Health Clinical Center (CC)
In plain English
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About this study
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 tissues in the development and maintenance of the Post-Acute Sequelae of COVID-19 (PASC)/Long COVID. Better understanding of how to recover and characterize SARS-CoV-2 viral remnants from humans is a valuable first step in understanding the health impact that they may have on humans. This study will focus on the recovery and characterization of SARS-CoV-2 remnants from multiple organ sites of individual volunteers with persistent neurological complications from SARS-CoV-2 (Neuro-PASC) and volunteers those who have recovered from a SARS-CoV-2 infection (RV).
Objectives:
* Primary Objective:
--To determine where remnants of SARS-CoV-2 virus can be recovered in persons with neuro-PASC and RVs.
* Secondary Objectives:
* To characterize the biochemical nature of SARS-CoV-2 recovered viral remnants (e.g. proteins, nucleic acids).
* To determine if there are quantitative differences in recovered SARS-CoV-2 proteins between neuro-PASC and RV participants.
* To determine if there are quantitative differences in recovered SARS-CoV-2 nucleic acids between neuro-PASC and RV participants.
Endpoints:
This is an exploratory cross-sectional protocol to determine whether the presence or absence of viral remnants can be detected in a range of human tissues. Hence, tissue-specific detection of viral remnants is the primary end point. Secondary endpoints will characterize and quantify the recovered remnants to allow group comparisons between neuro-PASC and RV participants.
Eligibility criteria
* 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.
Study design
Enrollment target: 12 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-03-27
Estimated completion: 2027-09-01
Last updated: 2026-06-04
Primary outcomes
- • To determine where remnants of SARS-CoV-2 virus can be recovered in persons with neuro-PASC and RVs. (Study End)
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS) · nih
Contacts & investigators
ContactAngelique A Gavin · contact · angelique.gavin@nih.gov · (301) 402-0880
ContactAvindra Nath, M.D. · contact · natha@mail.nih.gov · (301) 496-1561
InvestigatorAvindra Nath, M.D. · principal_investigator, National Institute of Neurological Disorders and Stroke (NINDS)
All locations (1)
National Institutes of Health Clinical CenterRecruiting
Bethesda, Maryland, United States