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.

NCT05067920 | Unknown

• 1 other identifier: LIME01P2021
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Laboratory biomarkers; Health condition; CT value; COVID-19; Mitochondrial DNA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Asymptomatic patients

60 patients without COVID-19 symptoms related at the time of diagnosis.

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

Symptomatic patients

60 patients with COVID-19 symptoms related at the time of diagnosis.

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

Interventions

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)

Asymptomatic patients; Symptomatic patients

rRT-PCR SARS-Cov-2 DIAGNOSTIC_TEST

Real time RT-PCR for COVID-19 diagnosis at day 5th,14th and 28th

Asymptomatic patients; Symptomatic patients

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.

Asymptomatic patients; Symptomatic patients

Mitochondrial DNA DIAGNOSTIC_TEST

One time quantification mitochondrial DNA haplogroup.

Asymptomatic patients; Symptomatic patients

SARS-CoV-2 Viral Culturing DIAGNOSTIC_TEST

Probability of isolating SARS-Cov-2 in cell culture related to CT value above 32.

Asymptomatic patients; Symptomatic patients

Sequencing COVID-19 DIAGNOSTIC_TEST

Sequencing viral protein spike (S) COVID-19 related to CT value below 15.

Asymptomatic patients; Symptomatic patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Immunocompromised patients
• Immunosuppressive treatments, chemotherapy or antiretroviral therapy
• Outpatient anticoagulation therapy
• Prior immunization for any vaccine in the last 3 months

Sponsors & Collaborators

• Universidad de Antioquia: lead
• Laboratorio departamental de salud publica de Antioquia: collaborator
• Sistema general de regalias (BPIN 2020000100152): collaborator

Study Sites (1)

Laboratorio Integrado de Medicina Especializada

Medellín, Antioquia, 050022, Colombia

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Andres F Zuluaga, MD, MSc, MeH

  Universidad de Antioquia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivone E Jimenez, PhD(c)

CONTACT

+57 (4) 2196022; ivone.jimenez@udea.edu.co

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full profesor, senior researcher and head of the Department of Pharmacology and Toxicology in Antioquia University

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: October 5, 2021
• Study Start: September 27, 2021
• Primary Completion: January 30, 2022
• Study Completion: January 31, 2022
• Last Updated: December 28, 2021

Record last verified: 2021-12

Locations

CO (1)