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.

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Covid19

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Asymptomatic patients<br>60 patients without COVID-19 symptoms related at the time of diagnosis. | Diagnostic Test: Levels of SARS-COV-2 antibodies<br>* Study of the SARS-COV-2 antibodies of COVID-19 IgM ( day 5th and 14th) and IgG ( day 14th and 28th)<br>Diagnostic Test: rRT-PCR SARS-Cov-2<br>* Real time RT-PCR for COVID-19 diagnosis at day 5th,14th and 28th<br>Diagnostic Test: Hematological and immunological biomarkers<br>* 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.<br>Diagnostic Test: Mitochondrial DNA<br>* One time quantification mitochondrial DNA haplogroup.<br>Diagnostic Test: SARS-CoV-2 Viral Culturing<br>* Probability of isolating SARS-Cov-2 in cell culture related to CT value above 32.<br>Diagnostic Test: Sequencing COVID-19<br>* Sequencing viral protein spike (S) COVID-19 related to CT value below 15.<br>|
| Symptomatic patients<br>60 patients with COVID-19 symptoms related at the time of diagnosis. | Diagnostic Test: Levels of SARS-COV-2 antibodies<br>* Study of the SARS-COV-2 antibodies of COVID-19 IgM ( day 5th and 14th) and IgG ( day 14th and 28th)<br>Diagnostic Test: rRT-PCR SARS-Cov-2<br>* Real time RT-PCR for COVID-19 diagnosis at day 5th,14th and 28th<br>Diagnostic Test: Hematological and immunological biomarkers<br>* 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.<br>Diagnostic Test: Mitochondrial DNA<br>* One time quantification mitochondrial DNA haplogroup.<br>Diagnostic Test: SARS-CoV-2 Viral Culturing<br>* Probability of isolating SARS-Cov-2 in cell culture related to CT value above 32.<br>Diagnostic Test: Sequencing COVID-19<br>* Sequencing viral protein spike (S) COVID-19 related to CT value below 15.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical 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 | Through study completion, an average of 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the duration of the positivity of the PCR test in asymptomatic and symptomatic patients through the follow-up |  | 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 |  | 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 |  | Through study completion, an average of 4 months | 
| Identification of polymorphic variants or mutations in COVID-19 patients |  | Through study completion, an average of 4 months | 
| Mitochondrial DNA haplogroup relation in people infected with SARS CoV2 |  | Through study completion, an average of 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laboratory biomarkers, Health condition, CT value, COVID-19, Mitochondrial DNA