Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577467
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
Cross-Sectional Evaluation of Persistence of SARS-CoV-2 Remnants After Recovery From Acute Infection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cross-Sectional Evaluation of Persistence of SARS-CoV-2 Remnants After Recovery From Acute Infection
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08-14
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 4 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
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 4 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
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 tissues in the development and maintenance of the Post-Acute Sequelae of COVID-19 PASCLong COVID Better understanding of how torecover 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 eg 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 remnants to allow group comparisons between neuro-PASC and RV participants
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 PASCLong COVID Better understanding of how torecover 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 eg 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 remnants to allow group comparisons between neuro-PASC and RV participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None