Clinical trial NCT05067920: 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.
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: Laboratory biomarkers
Health condition
CT value
COVID-19
Mitochondrial DNA
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
Collaborators: name: Laboratorio departamental de salud publica de Antioquia
name: Sistema general de regalias (BPIN 2020000100152)
First posted: 2021-10-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 confirmed patients with SARS-Cov-2 RT-PCR in Laboratorio Integrado de Medicina Especializada (LIME) or IPS Universitaria Clinica Leon XIII

Brief summary: 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.

Detailed description: 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.

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.

Eligibility criteria: Inclusion Criteria:

* People under 18 years old.
* Covid-19 diagnosis in the last seven days.
* Specimen analyzed at LIME laboratory
* Description of symptoms related to COVID-19

Exclusion Criteria:

* Immunocompromised patients
* Immunosuppressive treatments, chemotherapy or antiretroviral therapy
* Outpatient anticoagulation therapy
* Prior immunization for any vaccine in the last 3 months

Primary outcomes:
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
Secondary outcomes:
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
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Laboratorio Integrado de Medicina Especializada
state: Antioquia
Study officials:
affiliation: Universidad de Antioquia
name: Andres F Zuluaga, MD, MSc, MeH
role: PRINCIPAL_INVESTIGATOR
References: