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.

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05067920
• Other study ID #: LIME01P2021
• Status: Recruiting
• Start date: September 27, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: December 2021
• Source: Universidad de Antioquia
• Contact: Ivone E Jimenez, PhD(c)
• Phone: +57 (4) 2196022
• Email: ivone.jimenez[@]udea.edu.co
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 31, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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

Locations

Country	Name	City	State
Colombia	Laboratorio Integrado de Medicina Especializada	Medellin	Antioquia

Sponsors (3)

Lead Sponsor	Collaborator
Universidad de Antioquia	Laboratorio departamental de salud publica de Antioquia, Sistema general de regalias (BPIN 2020000100152)

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Identification of polymorphic variants or mutations in COVID-19 patients		Through study completion, an average of 4 months
Secondary	Mitochondrial DNA haplogroup relation in people infected with SARS CoV2		Through study completion, an average of 4 months