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.
NCT ID: NCT05067920
Last Updated: 2021-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
120 participants
OBSERVATIONAL
2021-09-27
2022-01-31
Brief Summary
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Detailed Description
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All 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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Asymptomatic patients
60 patients without COVID-19 symptoms related at the time of diagnosis.
Levels of SARS-COV-2 antibodies
Study of the SARS-COV-2 antibodies of COVID-19 IgM ( day 5th and 14th) and IgG ( day 14th and 28th)
rRT-PCR SARS-Cov-2
Real time RT-PCR for COVID-19 diagnosis at day 5th,14th and 28th
Hematological and immunological biomarkers
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.
Mitochondrial DNA
One time quantification mitochondrial DNA haplogroup.
SARS-CoV-2 Viral Culturing
Probability of isolating SARS-Cov-2 in cell culture related to CT value above 32.
Sequencing COVID-19
Sequencing viral protein spike (S) COVID-19 related to CT value below 15.
Symptomatic patients
60 patients with COVID-19 symptoms related at the time of diagnosis.
Levels of SARS-COV-2 antibodies
Study of the SARS-COV-2 antibodies of COVID-19 IgM ( day 5th and 14th) and IgG ( day 14th and 28th)
rRT-PCR SARS-Cov-2
Real time RT-PCR for COVID-19 diagnosis at day 5th,14th and 28th
Hematological and immunological biomarkers
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.
Mitochondrial DNA
One time quantification mitochondrial DNA haplogroup.
SARS-CoV-2 Viral Culturing
Probability of isolating SARS-Cov-2 in cell culture related to CT value above 32.
Sequencing COVID-19
Sequencing viral protein spike (S) COVID-19 related to CT value below 15.
Interventions
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Levels of SARS-COV-2 antibodies
Study of the SARS-COV-2 antibodies of COVID-19 IgM ( day 5th and 14th) and IgG ( day 14th and 28th)
rRT-PCR SARS-Cov-2
Real time RT-PCR for COVID-19 diagnosis at day 5th,14th and 28th
Hematological and immunological biomarkers
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.
Mitochondrial DNA
One time quantification mitochondrial DNA haplogroup.
SARS-CoV-2 Viral Culturing
Probability of isolating SARS-Cov-2 in cell culture related to CT value above 32.
Sequencing COVID-19
Sequencing viral protein spike (S) COVID-19 related to CT value below 15.
Eligibility Criteria
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Inclusion Criteria
* Covid-19 diagnosis in the last seven days.
* Specimen analyzed at LIME laboratory
* Description of symptoms related to COVID-19
Exclusion Criteria
* Immunosuppressive treatments, chemotherapy or antiretroviral therapy
* Outpatient anticoagulation therapy
* Prior immunization for any vaccine in the last 3 months
18 Years
99 Years
ALL
No
Sponsors
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Laboratorio departamental de salud publica de Antioquia
UNKNOWN
Sistema general de regalias (BPIN 2020000100152)
UNKNOWN
Universidad de Antioquia
OTHER
Responsible Party
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Andres Felipe Zuluaga Salazar
Full profesor, senior researcher and head of the Department of Pharmacology and Toxicology in Antioquia University
Principal Investigators
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Andres F Zuluaga, MD, MSc, MeH
Role: PRINCIPAL_INVESTIGATOR
Universidad de Antioquia
Locations
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Laboratorio Integrado de Medicina Especializada
Medellín, Antioquia, Colombia
Countries
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Central Contacts
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Facility Contacts
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Andres F Zuluaga
Role: primary
Other Identifiers
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LIME01P2021
Identifier Type: -
Identifier Source: org_study_id