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.

• Conditions: Covid19
• Interventions: 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

• Registration Number: NCT05067920
• Lead Sponsor: Universidad de Antioquia

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.

Study Timeline

• Study First Submitted: 2021-09-09
• Study Start: 2021-09-27
• Study First Submitted QC: 2021-10-01
• Study First Posted: 2021-10-05
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-27
• Last Update Posted: 2021-12-28
• Primary Completion: 2022-01-30
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Asymptomatic patients	rRT-PCR SARS-Cov-2	60 patients without COVID-19 symptoms related at the time of diagnosis.
Symptomatic patients	Levels of SARS-COV-2 antibodies	60 patients with COVID-19 symptoms related at the time of diagnosis.
Symptomatic patients	SARS-CoV-2 Viral Culturing	60 patients with COVID-19 symptoms related at the time of diagnosis.
Symptomatic patients	Hematological and immunological biomarkers	60 patients with COVID-19 symptoms related at the time of diagnosis.
Symptomatic patients	Mitochondrial DNA	60 patients with COVID-19 symptoms related at the time of diagnosis.
Asymptomatic patients	Mitochondrial DNA	60 patients without COVID-19 symptoms related at the time of diagnosis.
Asymptomatic patients	Sequencing COVID-19	60 patients without COVID-19 symptoms related at the time of diagnosis.
Symptomatic patients	rRT-PCR SARS-Cov-2	60 patients with COVID-19 symptoms related at the time of diagnosis.
Asymptomatic patients	Levels of SARS-COV-2 antibodies	60 patients without COVID-19 symptoms related at the time of diagnosis.
Asymptomatic patients	Hematological and immunological biomarkers	60 patients without COVID-19 symptoms related at the time of diagnosis.
Asymptomatic patients	SARS-CoV-2 Viral Culturing	60 patients without COVID-19 symptoms related at the time of diagnosis.
Symptomatic patients	Sequencing COVID-19	60 patients with COVID-19 symptoms related at the time of diagnosis.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Laboratorio Integrado de Medicina Especializada; 🇨🇴 Medellin, Antioquia, Colombia