Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-11 @ 10:32 PM
Study NCT ID:
NCT05067920
Status:
UNKNOWN
Last Update Posted:
2021-12-28
First Post:
2021-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Cycle Threshold (Ct) Values in COVID-19, Health Status and Laboratory Biomarkers in the Population of Medellin- Colombia Evaluated in a Specialized Laboratory.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-27', 'studyFirstSubmitDate': '2021-09-09', 'studyFirstSubmitQcDate': '2021-10-01', 'lastUpdatePostDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical immune response among COVID-19 patients related to CT value of rRT-PCR SARS-Cov-2', 'timeFrame': 'Through study completion, an average of 4 months', 'description': 'Calculated Ct value over 4 weeks, comparing the change in the immune status through the measurement of biomarkers'}], 'secondaryOutcomes': [{'measure': 'Determine the duration of the positivity of the PCR test in asymptomatic and symptomatic patients through the follow-up', 'timeFrame': 'Through study completion, an average of 4 months'}, {'measure': 'Evaluate differences in the titers of immunoglobulins M and G against anti-RBD domain of the protein S in SARS-CoV2', 'timeFrame': 'Through study completion, an average of 4 months'}, {'measure': 'Capacity of isolating the virus in cell culture with Ct> 32 by PCR in COVID-19 patients', 'timeFrame': 'Through study completion, an average of 4 months'}, {'measure': 'Identification of polymorphic variants or mutations in COVID-19 patients', 'timeFrame': 'Through study completion, an average of 4 months'}, {'measure': 'Mitochondrial DNA haplogroup relation in people infected with SARS CoV2', 'timeFrame': 'Through study completion, an average of 4 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laboratory biomarkers', 'Health condition', 'CT value', 'COVID-19', 'Mitochondrial DNA'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the correlation between the symptomaticity, Ct value, laboratory biomarkers associated to COVID-19 and the disease progression in hospitalized patients and outpatients with SARS-CoV2 infection diagnosed by RT-PCR assay for nasopharyngeal swab specimens in a specialized laboratory at Medellin,Colombia.', 'detailedDescription': 'After being informed about the study, all patients giving written informed consent will undergo a serial of test related to COVID-19. Rh and blood type will be obtained using the Colombian ID card or official document.\n\nAll symptomatic and asymptomatic COVID19-positive patients will be evaluated for a period of 4 weeks at three different times of the study. In a single time, the mitochondrial DNA will be measured, and the variability in the CT value, hemogram, cytokine levels, ratio of CD4 + / CD8 + lymphocytes, levels of dehydrogenase lactate, ferritin and D-dimer, antibodies IgG and IgM, will be measured on day 5, day 14 and day 28. In addition, spike S protein sequencing and growing the virus in cell culture that meet specific criteria will be performed. A physician will do clinical follow up through the period of the study for each patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COVID-19 confirmed patients with SARS-Cov-2 RT-PCR in Laboratorio Integrado de Medicina Especializada (LIME) or IPS Universitaria Clinica Leon XIII', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People under 18 years old.\n* Covid-19 diagnosis in the last seven days.\n* Specimen analyzed at LIME laboratory\n* Description of symptoms related to COVID-19\n\nExclusion Criteria:\n\n* Immunocompromised patients\n* Immunosuppressive treatments, chemotherapy or antiretroviral therapy\n* Outpatient anticoagulation therapy\n* Prior immunization for any vaccine in the last 3 months'}, 'identificationModule': {'nctId': 'NCT05067920', 'briefTitle': 'Correlation Between Cycle Threshold (Ct) Values in COVID-19, Health Status and Laboratory Biomarkers in the Population of Medellin- Colombia Evaluated in a Specialized Laboratory.', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Antioquia'}, 'officialTitle': 'Correlation Between Cycle Threshold (Ct) Values in RT-PCR - SARS-CoV-2, Health Status and Laboratory Biomarkers in the Population of Medellin- Colombia Evaluated in a Specialized Laboratory', 'orgStudyIdInfo': {'id': 'LIME01P2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Asymptomatic patients', 'description': '60 patients without COVID-19 symptoms related at the time of diagnosis.', 'interventionNames': ['Diagnostic Test: Levels of SARS-COV-2 antibodies', 'Diagnostic Test: rRT-PCR SARS-Cov-2', 'Diagnostic Test: Hematological and immunological biomarkers', 'Diagnostic Test: Mitochondrial DNA', 'Diagnostic Test: SARS-CoV-2 Viral Culturing', 'Diagnostic Test: Sequencing COVID-19']}, {'label': 'Symptomatic patients', 'description': '60 patients with COVID-19 symptoms related at the time of diagnosis.', 'interventionNames': ['Diagnostic Test: Levels of SARS-COV-2 antibodies', 'Diagnostic Test: rRT-PCR SARS-Cov-2', 'Diagnostic Test: Hematological and immunological biomarkers', 'Diagnostic Test: Mitochondrial DNA', 'Diagnostic Test: SARS-CoV-2 Viral Culturing', 'Diagnostic Test: Sequencing COVID-19']}], 'interventions': [{'name': 'Levels of SARS-COV-2 antibodies', 'type': 'DIAGNOSTIC_TEST', 'description': 'Study of the SARS-COV-2 antibodies of COVID-19 IgM ( day 5th and 14th) and IgG ( day 14th and 28th)', 'armGroupLabels': ['Asymptomatic patients', 'Symptomatic patients']}, {'name': 'rRT-PCR SARS-Cov-2', 'type': 'DIAGNOSTIC_TEST', 'description': 'Real time RT-PCR for COVID-19 diagnosis at day 5th,14th and 28th', 'armGroupLabels': ['Asymptomatic patients', 'Symptomatic patients']}, {'name': 'Hematological and immunological biomarkers', 'type': 'DIAGNOSTIC_TEST', 'description': 'Laboratory data measure at day 5th,14th and 28th: Hemogram, cytokine levels, ratio of CD4 + / CD8 + lymphocytes, and levels of dehydrogenase lactate, ferritin, D-dimer.', 'armGroupLabels': ['Asymptomatic patients', 'Symptomatic patients']}, {'name': 'Mitochondrial DNA', 'type': 'DIAGNOSTIC_TEST', 'description': 'One time quantification mitochondrial DNA haplogroup.', 'armGroupLabels': ['Asymptomatic patients', 'Symptomatic patients']}, {'name': 'SARS-CoV-2 Viral Culturing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Probability of isolating SARS-Cov-2 in cell culture related to CT value above 32.', 'armGroupLabels': ['Asymptomatic patients', 'Symptomatic patients']}, {'name': 'Sequencing COVID-19', 'type': 'DIAGNOSTIC_TEST', 'description': 'Sequencing viral protein spike (S) COVID-19 related to CT value below 15.', 'armGroupLabels': ['Asymptomatic patients', 'Symptomatic patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050022', 'city': 'Medellín', 'state': 'Antioquia', 'status': 'RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Andres F Zuluaga', 'role': 'CONTACT', 'phone': '+57 (4) 2196022'}], 'facility': 'Laboratorio Integrado de Medicina Especializada', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}], 'centralContacts': [{'name': 'Ivone E Jimenez, PhD(c)', 'role': 'CONTACT', 'email': 'ivone.jimenez@udea.edu.co', 'phone': '+57 (4) 2196022'}], 'overallOfficials': [{'name': 'Andres F Zuluaga, MD, MSc, MeH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Antioquia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Antioquia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Laboratorio departamental de salud publica de Antioquia', 'class': 'UNKNOWN'}, {'name': 'Sistema general de regalias (BPIN 2020000100152)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full profesor, senior researcher and head of the Department of Pharmacology and Toxicology in Antioquia University', 'investigatorFullName': 'Andres Felipe Zuluaga Salazar', 'investigatorAffiliation': 'Universidad de Antioquia'}}}}