Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2025-12-25 @ 12:46 AM
NCT ID:
NCT06577467
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
110 Years
Study:
NCT06577467
Study Brief:
Protocol Section:
NCT06577467