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.

December 27, 2021 updated by: Andres Felipe Zuluaga Salazar, Universidad de Antioquia

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 050022
        • Recruiting
        • Laboratorio Integrado de Medicina Especializada
        • Contact:
          • Andres F Zuluaga
          • Phone Number: +57 (4) 2196022

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

COVID-19 confirmed patients with SARS-Cov-2 RT-PCR in Laboratorio Integrado de Medicina Especializada (LIME) or IPS Universitaria Clinica Leon XIII

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Asymptomatic patients
60 patients without COVID-19 symptoms related at the time of diagnosis.
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)
Diagnostic test: rRT-PCR SARS-Cov-2
Real time RT-PCR for COVID-19 diagnosis at day 5th,14th and 28th
Diagnostic test: 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.
Diagnostic test: Mitochondrial DNA
One time quantification mitochondrial DNA haplogroup.
Diagnostic test: SARS-CoV-2 Viral Culturing
Probability of isolating SARS-Cov-2 in cell culture related to CT value above 32.
Diagnostic test: Sequencing COVID-19
Sequencing viral protein spike (S) COVID-19 related to CT value below 15.
Symptomatic patients
60 patients with COVID-19 symptoms related at the time of diagnosis.
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)
Diagnostic test: rRT-PCR SARS-Cov-2
Real time RT-PCR for COVID-19 diagnosis at day 5th,14th and 28th
Diagnostic test: 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.
Diagnostic test: Mitochondrial DNA
One time quantification mitochondrial DNA haplogroup.
Diagnostic test: SARS-CoV-2 Viral Culturing
Probability of isolating SARS-Cov-2 in cell culture related to CT value above 32.
Diagnostic test: Sequencing COVID-19
Sequencing viral protein spike (S) COVID-19 related to CT value below 15.

What is the study measuring?

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
Time Frame: 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
Through study completion, an average of 4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
Through study completion, an average of 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Antioquia

Collaborators

Laboratorio departamental de salud publica de Antioquia
Sistema general de regalias (BPIN 2020000100152)

Investigators

  • Principal Investigator: Andrés F Zuluaga, MD, MSc, MeH, Universidad de Antioquia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2021

Primary Completion (Anticipated)

January 30, 2022

Study Completion (Anticipated)

January 31, 2022

Study Registration Dates

First Submitted

September 9, 2021

First Submitted That Met QC Criteria

October 1, 2021

First Posted (Actual)

October 5, 2021

Study Record Updates

Last Update Posted (Actual)

December 28, 2021

Last Update Submitted That Met QC Criteria

December 27, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIME01P2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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