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.

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Universidad de Antioquia · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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)
DIAGNOSTIC_TEST	rRT-PCR SARS-Cov-2	Real time RT-PCR for COVID-19 diagnosis at day 5th,14th and 28th
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	Mitochondrial DNA	One time quantification mitochondrial DNA haplogroup.
DIAGNOSTIC_TEST	SARS-CoV-2 Viral Culturing	Probability of isolating SARS-Cov-2 in cell culture related to CT value above 32.
DIAGNOSTIC_TEST	Sequencing COVID-19	Sequencing viral protein spike (S) COVID-19 related to CT value below 15.

Timeline

• Start date: 2021-09-27
• Primary completion: 2022-01-30
• Completion: 2022-01-31
• First posted: 2021-10-05
• Last updated: 2021-12-28

Locations

1 site across 1 country: Colombia