Covid19NCT05067920
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.
An observational study of Covid19, run by Universidad de Antioquia at 1 site in Colombia.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Covid19
- What is being tested?
- Levels of SARS-COV-2 antibodies, rRT-PCR SARS-Cov-2 and Hematological and immunological biomarkers
- How many people
- 120 participants
- Where
- 1 siteColombia
- Study dates
- 27 Sep 2021to 31 Jan 2022
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Immunocompromised patients
- Immunosuppressive treatments, chemotherapy or antiretroviral therapy
- Outpatient anticoagulation therapy
- Prior immunization for any vaccine in the last 3 months
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Laboratorio Integrado de Medicina Especializada
Medellín, Antioquia, 050022
Andres F Zuluaga, +57 (4) 2196022
About this study
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
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Levels of SARS-COV-2 antibodies, rRT-PCR SARS-Cov-2, Hematological and immunological biomarkers, Mitochondrial DNA, SARS-CoV-2 Viral Culturing
- Keywords
- Laboratory biomarkers, Health condition, CT value, COVID-19, Mitochondrial DNA
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levels of SARS-COV-2 antibodiesDiagnostic test
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-2Diagnostic test
Real time RT-PCR for COVID-19 diagnosis at day 5th,14th and 28th
Hematological and immunological biomarkersDiagnostic 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.
Mitochondrial DNADiagnostic test
One time quantification mitochondrial DNA haplogroup.
SARS-CoV-2 Viral CulturingDiagnostic test
Probability of isolating SARS-Cov-2 in cell culture related to CT value above 32.
Sequencing COVID-19Diagnostic test
Sequencing viral protein spike (S) COVID-19 related to CT value below 15.
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic patients | 60 patients without COVID-19 symptoms related at the time of diagnosis. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 4 months
Identification of polymorphic variants or mutations in COVID-19 patients
Measured: Through study completion, an average of 4 months
Mitochondrial DNA haplogroup relation in people infected with SARS CoV2
Measured: Through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start27 Sep 2021
- Primary completion30 Jan 2022 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratorio departamental de salud publica de Antioquia, Sistema general de regalias (BPIN 2020000100152)
- Responsible party
- Principal investigator, Andres Felipe Zuluaga Salazar, Universidad de Antioquia
- Investigators
- Andres F Zuluaga, MD, MSc, MeH, Principal investigator, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067920
- Sponsor's protocol ID
- LIME01P2021
- Status last verified
- Dec 2021
- First submitted
- 9 Sep 2021
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05067920
- Acronym / sponsor ID
- LIME01P2021
- Conditions
- Covid19
- Keywords
- Laboratory biomarkers, Health condition, CT value, COVID-19, Mitochondrial DNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Collaborators
- Laboratorio departamental de salud publica de Antioquia, Sistema general de regalias (BPIN 2020000100152)
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 5 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic patients | – | 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-1960 patients without COVID-19 symptoms related at the time of diagnosis. |
| Symptomatic patients | – | 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-1960 patients with COVID-19 symptoms related at the time of diagnosis. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Immunocompromised patients
- Immunosuppressive treatments, chemotherapy or antiretroviral therapy
- Outpatient anticoagulation therapy
- Prior immunization for any vaccine in the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levels of SARS-COV-2 antibodiesStudy of the SARS-COV-2 antibodies of COVID-19 IgM ( day 5th and 14th) and IgG ( day 14th and 28th) | Diagnostic test | Asymptomatic patients, Symptomatic patients |
| rRT-PCR SARS-Cov-2Real time RT-PCR for COVID-19 diagnosis at day 5th,14th and 28th | Diagnostic test | Asymptomatic patients, Symptomatic patients |
| Hematological and immunological biomarkersLaboratory 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 | Asymptomatic patients, Symptomatic patients |
| Mitochondrial DNAOne time quantification mitochondrial DNA haplogroup. | Diagnostic test | Asymptomatic patients, Symptomatic patients |
| SARS-CoV-2 Viral CulturingProbability of isolating SARS-Cov-2 in cell culture related to CT value above 32. | Diagnostic test | Asymptomatic patients, Symptomatic patients |
| Sequencing COVID-19Sequencing viral protein spike (S) COVID-19 related to CT value below 15. | Diagnostic test | Asymptomatic patients, Symptomatic patients |
Primary outcome
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
5 secondary outcomes
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
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
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
Identification of polymorphic variants or mutations in COVID-19 patients
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andres F Zuluaga, MD, MSc, MeH principal investigator
Universidad de Antioquia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Universidad de Antioquia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ivone E Jimenez, PhD(c) (+57 (4) 2196022, ivone.jimenez@udea.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2021.