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.
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.
Study Type
OBSERVATIONAL
Enrollment
120
Study of the SARS-COV-2 antibodies of COVID-19 IgM ( day 5th and 14th) and IgG ( day 14th and 28th)
Real time RT-PCR for COVID-19 diagnosis at day 5th,14th and 28th
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.
Laboratorio Integrado de Medicina Especializada
Medellín, Antioquia, Colombia
RECRUITINGClinical immune response among COVID-19 patients related to CT value of rRT-PCR SARS-Cov-2
Calculated Ct value over 4 weeks, comparing the change in the immune status through the measurement of biomarkers
Time frame: Through study completion, an average of 4 months
Determine the duration of the positivity of the PCR test in asymptomatic and symptomatic patients through the follow-up
Time frame: Through study completion, an average of 4 months
Evaluate differences in the titers of immunoglobulins M and G against anti-RBD domain of the protein S in SARS-CoV2
Time frame: Through study completion, an average of 4 months
Capacity of isolating the virus in cell culture with Ct> 32 by PCR in COVID-19 patients
Time frame: Through study completion, an average of 4 months
Identification of polymorphic variants or mutations in COVID-19 patients
Time frame: Through study completion, an average of 4 months
Mitochondrial DNA haplogroup relation in people infected with SARS CoV2
Time frame: Through study completion, an average of 4 months
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One time quantification mitochondrial DNA haplogroup.
Probability of isolating SARS-Cov-2 in cell culture related to CT value above 32.
Sequencing viral protein spike (S) COVID-19 related to CT value below 15.