Covid19MicroNAV-IINCT04944823
Characterization Immunology, Biochemical and Lung Microbiome, Correlated With the Ventilation Associated Pneumonia (VAP)
An observational study of Covid19 and SARS-CoV Infection, run by Universidad de la Sabana at 1 site in Colombia.
Trial summary
SARS-CoV-2, the virus that causes COVID-19, is currently a global public health problem, declared a pandemic by the World Health Organization, which today has more than one million deaths in the world, of which , 30,000 approximately belong to Colombia, being the country number 11 with the highest number of deaths. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, SARS-CoV Infection
- What is being tested?
- Clinical follow-up for 24 months
- How many people
- 50 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jul 2021to Apr 2023
- How long will I take part?
- 2 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to the Intensive Care Unit of the Clínica Universitaria de la Sabana, with a diagnosis of COVID-19 by RT-PCR, who require invasive mechanical ventilation due to respiratory failure as a result of the infection and who approve their participation in the study. It is important to highlight that these patients are sedated and cannot agree to participate in the study; therefore, the patient's relatives or legal representative will be in charge of defining the participation of the relative in the study.
Who may be able to join
- Patients admitted to the ICU, COVID-19 positive by RT-PCR, who require assisted mechanical ventilation.
- Adult patients over 18 years of age.
- Patients who agree to participate in the study and sign the informed consent form (family members or legal representative).
- Patients in whom the identification of the causative agent of coinfection is attempted within the first 48 hours of hospitalization.
Who cannot join
- Patient on mechanical ventilation for more than 24 hours without being evaluated for study entry.
- Patient who was treated with antibiotics 7 days prior to hospitalization or time of assessment for the study.
- Pregnant or breastfeeding patients.
- People who belong to population groups with increased vulnerability such as, for example, prison population, minors detained in orphanages or people in street situations.
- No research procedure, clinical or paraclinical, or taking of clinical information or biological samples will be performed before the patient or his/her legal representative agrees to participate in the study and signs the informed consent form.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Clinica Universidad De La Sabana
Chía, Cundinamarca
Luis F Reyes, MD, +57 3175130128, luis.reyes5@unisabana.edu.co
Ingrid G Bustos, BsC, +57 3115421277, ingridbusmo@unisabana.edu.co
About this study
Official title: Characterization of Cellular Immunology, Biochemical and Lung Microbiome, Correlated With the Development of Ventilation Associated Pneumonia (VAP) in Adult Patients Admitted to the Intensive Care Unit (ICU): The Second Stage.
SARS-CoV-2, the virus that causes COVID-19, is currently a global public health problem, declared a pandemic by the World Health Organization, which today has more than one million deaths in the world, of which , 30,000 approximately belong to Colombia, being the country number 11 with the highest number of deaths. The most common symptoms related to this disease are fever, cough, dyspnea, myalgia, headache, diarrhea and rhinorrhea. COVID-19 is characterized by immune system dysfunction and hyperinflammation causing acute respiratory distress syndrome, macrophage activation, and coagulopathy. The clinical course for SARS-CoV-2 in most cases is mild, but approximately 14% of cases can be severe. In pneumonia caused by SARS-CoV-2, the lung lining is known to alter the composition of the lung microbiome, in addition to lymphocyte damage that can promote the growth of bacteria to initiate bacterial pneumonia, and it is estimated that the prevalence of coinfection / superinfection reaches 50% among deaths from COVID-19. Coinfection between different microorganisms and SARS-CoV-2 is a serious problem in the COVID-19 pandemic, and there is still little information on this.
It is for this reason that the researchs propose to develop this research project that will allow to understand the possible mechanisms associated with the development of bacterial coinfection / superinfection in patients diagnosed with COVID-19, which will allow expanding the panorama of knowledge towards a better and adequate treatment in these patients, as well as detection of biomarkers or clinical phenotypics that may be useful in the diagnosis, based on evidence.
It is important to note that these results are of clinical importance since we will try to identify biomarkers or changes in the lung microbiome that allow doctors to early identify patients at risk of developing coinfection and thus initiate early treatments or preventive measures, which allow the improvement of clinical outcomes in patients. Results will be presented in a timely manner at national and international conferences and in peer-reviewed, indexed, high-impact journals.
Read the detailed description
This is a prospective, translational (T0-T2), multicenter, observational, cohort study of consecutive patients with a first clinical phase, where the collection of different types of samples (Bronco alveolar lavage, blood, nasopharyngeal swab, secretion orotracheal and rectal swabbing) at the start of mechanical ventilation, on day 3 and before extubation and another stage of molecular analysis in human samples collected where by different types of techniques such as: characterization of the 16S ribosomal unit, ELISA, time PCR real, concentration and cell discrimination techniques, we will characterize the microbiological, immunological and cellular changes that condition the development of coinfection.
Descriptive analytical studies, techniques, and parametric and nonparametric tests will be used to explore diagnostic, microbiological, or subgroup differences, as well as clinical outcomes. Independent predictors and associated hazard ratios with 95% confidence intervals will be reported. A two-tailed p value less than 0.05 will be considered statistically significant.
- Conditions
- Covid19, SARS-CoV Infection
- Being tested
- Clinical follow-up for 24 months
- Keywords
- pulmonary microbiome, SARS-CoV Infection, Covid19
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical follow-up for 24 monthsOther
Sampling and clinical follow-up for 24 months
| Study group | Role | What they receive |
|---|---|---|
| Patients with COVID 19 infection who develop bacterial coinfection. | Follow-up for 24 months Receives: Other: Clinical follow-up for 24 months | |
| Patients with COVID 19 infection who do not develop bacterial coinfection. | Follow-up for 24 months Receives: Other: Clinical follow-up for 24 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the pulmonary microbiome and changes in microbial diversity in patients with severe COVID.
To observe the change that occur in the diversity of the pulmonary microbiome in patients with severe COVID, with mechanical ventilation. The pulmonary microbiome will be analyzed at 4 four times during the patient's mechanical ventilation (baseline, 72 hours, fifth day, seventh day or if he/she develops co-infection or superinfection).
Measured: 24 months
Correlation between microbial diversity and host immune response with severe COVID.
To analyze whether changes in microbial diversity have any association with the host immune response leading to increased susceptibility to co-infection or superinfection during COVID disease.
Measured: 24 months
Secondary outcomes (2)
Percentage of coinfected/overinfected patients with severe COVID and the diversity of the pulmonary microbiome.
To observe patterns of lung microbiome diversity in patients with severe COVID that will help us predict the development of coinfection or superinfection in these patients.
Measured: 24 months
Immunologic or cellular patterns in coinfection or superinfection in patients with severe COVID.
To describe immunological or cellular patterns in patients with severe COVID that will help us predict the development of coinfection or superinfection in these patients.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start1 Jul 2021 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionApr 2023 (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
- 50 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Universidad de la Sabana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944823
- Sponsor's protocol ID
- MED-286-2020
- Acronym
- MicroNAV-II
- Status last verified
- Jun 2021
- First submitted
- 10 Jun 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: confidentiality agreement
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Cellular Immunology, Biochemical and Lung Microbiome, Correlated With the Development of Ventilation Associated Pneumonia (VAP) in Adult Patients Admitted to the Intensive Care Unit (ICU): The Second Stage.
- ClinicalTrials.gov ID
- NCT04944823
- Acronym / sponsor ID
- MicroNAV-II / MED-286-2020
- Conditions
- Covid19, SARS-CoV Infection
- Keywords
- pulmonary microbiome, SARS-CoV Infection, Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidad de la SabanaUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 30 Jun 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.
SARS-CoV-2, the virus that causes COVID-19, is currently a global public health problem, declared a pandemic by the World Health Organization, which today has more than one million deaths in the world, of which , 30,000 approximately belong to Colombia, being the country number 11 with the highest number of deaths. The most common symptoms related to this disease are fever, cough, dyspnea, myalgia, headache, diarrhea and rhinorrhea. COVID-19 is characterized by immune system dysfunction and hyperinflammation causing acute respiratory distress syndrome, macrophage activation, and coagulopathy. The clinical course for SARS-CoV-2 in most cases is mild, but approximately 14% of cases can be severe. In pneumonia caused by SARS-CoV-2, the lung lining is known to alter the composition of the lung microbiome, in addition to lymphocyte damage that can promote the growth of bacteria to initiate bacterial pneumonia, and it is estimated that the prevalence of coinfection / superinfection reaches 50% among deaths from COVID-19. Coinfection between different microorganisms and SARS-CoV-2 is a serious problem in the COVID-19 pandemic, and there is still little information on this.
It is for this reason that the researchs propose to develop this research project that will allow to understand the possible mechanisms associated with the development of bacterial coinfection / superinfection in patients diagnosed with COVID-19, which will allow expanding the panorama of knowledge towards a better and adequate treatment in these patients, as well as detection of biomarkers or clinical phenotypics that may be useful in the diagnosis, based on evidence.
It is important to note that these results are of clinical importance since we will try to identify biomarkers or changes in the lung microbiome that allow doctors to early identify patients at risk of developing coinfection and thus initiate early treatments or preventive measures, which allow the improvement of clinical outcomes in patients. Results will be presented in a timely manner at national and international conferences and in peer-reviewed, indexed, high-impact journals.
Detailed description
This is a prospective, translational (T0-T2), multicenter, observational, cohort study of consecutive patients with a first clinical phase, where the collection of different types of samples (Bronco alveolar lavage, blood, nasopharyngeal swab, secretion orotracheal and rectal swabbing) at the start of mechanical ventilation, on day 3 and before extubation and another stage of molecular analysis in human samples collected where by different types of techniques such as: characterization of the 16S ribosomal unit, ELISA, time PCR real, concentration and cell discrimination techniques, we will characterize the microbiological, immunological and cellular changes that condition the development of coinfection.
Descriptive analytical studies, techniques, and parametric and nonparametric tests will be used to explore diagnostic, microbiological, or subgroup differences, as well as clinical outcomes. Independent predictors and associated hazard ratios with 95% confidence intervals will be reported. A two-tailed p value less than 0.05 will be considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with COVID 19 infection who develop bacterial coinfection. | – | Other: Clinical follow-up for 24 monthsFollow-up for 24 months |
| Patients with COVID 19 infection who do not develop bacterial coinfection. | – | Other: Clinical follow-up for 24 monthsFollow-up for 24 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the Intensive Care Unit of the Clínica Universitaria de la Sabana, with a diagnosis of COVID-19 by RT-PCR, who require invasive mechanical ventilation due to respiratory failure as a result of the infection and who approve their participation in the study. It is important to highlight that these patients are sedated and cannot agree to participate in the study; therefore, the patient's relatives or legal representative will be in charge of defining the participation of the relative in the study.
Key inclusion criteria (4 listed)
- Patients admitted to the ICU, COVID-19 positive by RT-PCR, who require assisted mechanical ventilation.
- Adult patients over 18 years of age.
- Patients who agree to participate in the study and sign the informed consent form (family members or legal representative).
- Patients in whom the identification of the causative agent of coinfection is attempted within the first 48 hours of hospitalization.
Key exclusion criteria (5 listed)
- Patient on mechanical ventilation for more than 24 hours without being evaluated for study entry.
- Patient who was treated with antibiotics 7 days prior to hospitalization or time of assessment for the study.
- Pregnant or breastfeeding patients.
- People who belong to population groups with increased vulnerability such as, for example, prison population, minors detained in orphanages or people in street situations.
- No research procedure, clinical or paraclinical, or taking of clinical information or biological samples will be performed before the patient or his/her legal representative agrees to participate in the study and signs the informed consent form.
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 |
|---|---|---|
| Clinical follow-up for 24 monthsSampling and clinical follow-up for 24 months | Other | Patients with COVID 19 infection who develop bacterial coinfection., Patients with COVID 19 infection who do not develop bacterial coinfection. |
Primary outcome
Identification of the pulmonary microbiome and changes in microbial diversity in patients with severe COVID.
Time frame: 24 months
To observe the change that occur in the diversity of the pulmonary microbiome in patients with severe COVID, with mechanical ventilation. The pulmonary microbiome will be analyzed at 4 four times during the patient's mechanical ventilation (baseline, 72 hours, fifth day, seventh day or if he/she develops co-infection or superinfection).
Correlation between microbial diversity and host immune response with severe COVID.
Time frame: 24 months
To analyze whether changes in microbial diversity have any association with the host immune response leading to increased susceptibility to co-infection or superinfection during COVID disease.
2 secondary outcomes
Percentage of coinfected/overinfected patients with severe COVID and the diversity of the pulmonary microbiome.
Time frame: 24 months
Immunologic or cellular patterns in coinfection or superinfection in patients with severe COVID.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Individual participant dataSharing planned: No. confidentiality agreement
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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.
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 and SARS-CoV Infection, run by Universidad de la Sabana 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 5 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 30 Jun 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 Luis F Reyes, MD (+57 3175130128, luis.reyes5@unisabana.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of the pulmonary microbiome and changes in microbial diversity in patients with severe COVID. (time frame: 24 months). The study lists 2 primary outcomes in all. 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 30 Jun 2021.