Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT05131594
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-09-19
First Post:
2021-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Response of the Immune System of People with Long COVID (post SARS-CoV-2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-11', 'studyFirstSubmitDate': '2021-11-19', 'studyFirstSubmitQcDate': '2021-11-19', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of symptomatology with inflammatory profiles in patients with Post-Acute Sequelae of SARS-CoV2 (PASC)', 'timeFrame': 'From onset of infection to 24 months', 'description': 'Do patient symptoms correlate with abnormalities in inflammatory profiles?'}, {'measure': 'Identification of immunologic and inflammatory features of PASC based on results of immunologic and inflammatory assays', 'timeFrame': 'From onset of infection to 24 months', 'description': 'Are there abnormalities in immunologic and inflammatory assays unique to PASC?'}, {'measure': 'Evaluation and delineation of the pathologic pathways and long-term effects of SARS-CoV2 infection', 'timeFrame': 'From onset of infection to 60 months', 'description': 'What are the pathological pathways and long-term effects of SARS-CoV2?'}, {'measure': 'Identification of risks factor for PASC', 'timeFrame': 'From onset of infection to 24 months', 'description': 'What are the risk factors for PASC?'}, {'measure': 'Identification of potential sites of therapeutic intervention to ameliorate symptomatology of PASC', 'timeFrame': 'From onset of infection to 60 months', 'description': 'Are there potential sites of therapeutic intervention to relieve the symptoms of PASC?'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['post-acute sequelae of SARS-CoV2', 'post-acute COVID-19 syndrome', 'long COVID'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'Many people who have had COVID 19 continue to experience symptoms long after they have recovered from the acute infection. This study will examine the clinical symptoms of people with "Long COVID" and measure various markers of inflammation in their blood.', 'detailedDescription': 'Patients who attend the Long Covid Recovery Clinic at Huntington Hospital will be offered participation in the study. After giving written informed consent, their medical history along with a description of clinical symptoms given through an extensive questionnaire will be accessed. Venous blood will be collected as a baseline and then at follow up visits (as dictated by changes in clinical symptomatology) for evaluation of corollary immune parameters. Patients will be followed at a minimum of every 2 months for 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Adult patients (18 years old or older) who enroll in Huntington Hospital's Long Covid Recovery Clinic will be offered but are under no obligation to participate in this study. Subjects will have documented previous infection with SARS-CoV2 and symptoms suggestive of post-acute sequelae of SARS-CoV2 (including but not limited to chronic fatigue, brain fog, muscle and joint pain, cardiac and pulmonary issues, or other factors related to their acute COVID-19 event).", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolled in Huntington Hospital\\'s Long Covid Recovery Clinic\n* Documented previous infection with SARS-CoV2\n* Symptoms suggestive of post-acute sequelae of SARS-CoV2 (including but not limited to chronic fatigue, brain fog, muscle and joint pain, cardiac and pulmonary issues, or other factors related to their acute COVID-19 event)\n* Signed Informed Consent Form\n\nExclusion Criteria:\n\n* No documented positive SARS-CoV2 serologies\n* No post-acute sequelae of SARS-CoV2 symptomatology\n* Incarcerated'}, 'identificationModule': {'nctId': 'NCT05131594', 'acronym': 'LCRC', 'briefTitle': 'Evaluating the Response of the Immune System of People with Long COVID (post SARS-CoV-2)', 'organization': {'class': 'OTHER', 'fullName': 'Huntington Memorial Hospital'}, 'officialTitle': 'Immune Response to Post Acute Sequelae of SARSCoV2: a Correlation of Clinical Symptoms and Inflammatory Pathways', 'orgStudyIdInfo': {'id': 'Pro00054801'}}, 'contactsLocationsModule': {'locations': [{'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Huntington Hospital', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}], 'overallOfficials': [{'name': 'Kimberly Shriner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huntington Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huntington Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'San Diego Biomedical Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}