NCT06577467|Recruiting
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Sponsor study identifier
Secondary identifiers
observational
12
1 country
1
Study Start
March 27, 2025
Actual (reported)Primary Completion
September 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 28, 2024
Actual (reported)August 29, 2024
Actual (reported)March 27, 2025
Actual (reported)September 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Study End
1.To characterize the biochemical nature of SARS-CoV-2 recovered viral remnants (e.g. proteins, nucleic acids).PASC and RV participants.
Study End
2.To determine if there are quantitative differences in recovered SARS-CoV-2 proteins between neuro-PASC and RV participants.
Study End
3.To determine if there are quantitative differences in recovered SARS-CoV-2 nucleic acids between neuro-PASC and RV participants.
Study End
1.\<TAB\>Neurologic and neuropsychiatric complaint is the primary clinical issue. 2.\<TAB\>Neuro-PASC clinical symptom burden is moderate or greater.3.\<TAB\>Other PASC complications, such as pulmonary, cardiovascular, or gastrointestinal symptoms, are not prominent case features.
1.\<TAB\>Reports no ongoing or new health issues attributable to a SARS-CoV-2 infection2.\<TAB\>Overall clinical symptoms burden is no greater than mild3.\<TAB\>No clinically substantial comorbid medical or psychiatric conditions
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
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Avindra Nath, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
First Submitted
August 28, 2024
First Posted
August 29, 2024
Study Start
March 27, 2025
Actual (reported)Primary Completion
September 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Evaluating the Neuromodulatory Effect of Ketamine in Long COVID-19
Contact the study team to confirm eligibility.
Study Completion
September 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 16, 2026
Record last verified: 2026-08-04
All collected IPD will be shared that underlie results in a publication.
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Source: ClinicalTrials.gov.
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