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| Name | Class |
|---|---|
| Laboratorio departamental de salud publica de Antioquia | UNKNOWN |
| Sistema general de regalias (BPIN 2020000100152) | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asymptomatic patients | 60 patients without COVID-19 symptoms related at the time of diagnosis. |
| |
| Symptomatic patients | 60 patients with COVID-19 symptoms related at the time of diagnosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levels of SARS-COV-2 antibodies | Diagnostic Test | Study of the SARS-COV-2 antibodies of COVID-19 IgM ( day 5th and 14th) and IgG ( day 14th and 28th) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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COVID-19 confirmed patients with SARS-Cov-2 RT-PCR in Laboratorio Integrado de Medicina Especializada (LIME) or IPS Universitaria Clinica Leon XIII
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ivone E Jimenez, PhD(c) | Contact | +57 (4) 2196022 | ivone.jimenez@udea.edu.co |
| Name | Affiliation | Role |
|---|---|---|
| Andres F Zuluaga, MD, MSc, MeH | Universidad de Antioquia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratorio Integrado de Medicina Especializada | Recruiting | MedellÃn | Antioquia | 050022 | Colombia |
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| rRT-PCR SARS-Cov-2 | Diagnostic Test | Real time RT-PCR for COVID-19 diagnosis at day 5th,14th and 28th |
|
| Hematological and immunological biomarkers | Diagnostic Test | 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. |
|
| Mitochondrial DNA | Diagnostic Test | One time quantification mitochondrial DNA haplogroup. |
|
| SARS-CoV-2 Viral Culturing | Diagnostic Test | Probability of isolating SARS-Cov-2 in cell culture related to CT value above 32. |
|
| Sequencing COVID-19 | Diagnostic Test | Sequencing viral protein spike (S) COVID-19 related to CT value below 15. |
|
| 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 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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