Covid19
Conditions
Keywords
Laboratory biomarkers, Health condition, CT value, COVID-19, Mitochondrial DNA
Brief 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.
Interventions
DIAGNOSTIC_TESTLevels 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_TESTrRT-PCR SARS-Cov-2
Real time RT-PCR for COVID-19 diagnosis at day 5th,14th and 28th
DIAGNOSTIC_TESTHematological 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_TESTMitochondrial DNA
One time quantification mitochondrial DNA haplogroup.
DIAGNOSTIC_TESTSARS-CoV-2 Viral Culturing
Probability of isolating SARS-Cov-2 in cell culture related to CT value above 32.
DIAGNOSTIC_TESTSequencing COVID-19
Sequencing viral protein spike (S) COVID-19 related to CT value below 15.
Sponsors
Laboratorio departamental de salud publica de Antioquia
Sistema general de regalias (BPIN 2020000100152)
Universidad de Antioquia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical immune response among COVID-19 patients related to CT value of rRT-PCR SARS-Cov-2 | Through study completion, an average of 4 months | Calculated Ct value over 4 weeks, comparing the change in the immune status through the measurement of biomarkers |
Secondary
| Measure | 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 |
Countries
Colombia
Contacts
Primary ContactIvone E Jimenez, PhD(c)
Outcome results
None listed