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.

Universidad de Antioquia

Status: Unknown

Conditions: Covid19

Treatments: Diagnostic Test: Hematological and immunological biomarkers; Diagnostic Test: Levels of SARS-COV-2 antibodies; Diagnostic Test: Mitochondrial DNA; Diagnostic Test: Sequencing COVID-19; Diagnostic Test: SARS-CoV-2 Viral Culturing; Diagnostic Test: rRT-PCR SARS-Cov-2

Study type: Observational

Funder types: Other

Identifiers

NCT05067920

LIME01P2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

Asymptomatic patients

Description:

60 patients without COVID-19 symptoms related at the time of diagnosis.

Treatment:

Diagnostic Test: SARS-CoV-2 Viral Culturing

Diagnostic Test: Hematological and immunological biomarkers

Diagnostic Test: Mitochondrial DNA

Diagnostic Test: Sequencing COVID-19

Diagnostic Test: rRT-PCR SARS-Cov-2

Diagnostic Test: Levels of SARS-COV-2 antibodies

Symptomatic patients

Description:

60 patients with COVID-19 symptoms related at the time of diagnosis.

Treatment:

Diagnostic Test: SARS-CoV-2 Viral Culturing

Diagnostic Test: Hematological and immunological biomarkers

Diagnostic Test: Mitochondrial DNA

Diagnostic Test: Sequencing COVID-19

Diagnostic Test: rRT-PCR SARS-Cov-2

Diagnostic Test: Levels of SARS-COV-2 antibodies