COVID-19 PneumoniaNCT05767853
Multiparametric Assessment of Peripheral Blood and Tissue Myeloid Cells. Phenotype for Precision Medicine in Patients With SARS-Cov-2 Infection
An observational study of COVID-19 Pneumonia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites in 2 countries.
Trial summary
We hypothesise that patients with SARS-Cov-2 infection are characterized by progressive changes in distribution of distinct lung macrophages populations mediated by influx of circulating monocytes into the lungs . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Immune-phenotyping of tissue and peripheral blood myeloid compartment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 May 2020to 30 Jun 2023
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Patients hospedalized for Covid-19 pneumonia.
Who may be able to join
- Patients with COVID-19 pneumonia
Who cannot join
- Other infections rather than Covid-19
- Patients with concomitant treatment with prednisone ≥10 mg daily
- Patients under therapy with immunosuppressants
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Italy1 site, 1 recruiting
- Recruiting
Division of Rheumatology
Rome, Lazio, 00168
Stefano Alivernini, MD, PhD, 00390630154503, stefano.alivernini@policlinicogemelli.it
United Kingdom1 site
- Active, not recruiting
School of Infection and Immunity
Glasgow
About this study
Official title: Multiparametric Assessment of Peripheral Blood and Tissue Myeloid Cells Phenotype Associated With Severe Lung Manifestations and Cytokines Storm for Precision Medicine in Patients With SARS-Cov-2 Infection.
We hypothesise that patients with SARS-Cov-2 infection are characterized by progressive changes in distribution of distinct lung macrophages populations mediated by influx of circulating monocytes into the lungs . Moreover, we also hypothesise that patients with higher rate of MerTKpos alveolar macrophages in the lung lavage will have the lowest rate of lung complications and the best recovery outcome in terms of clinical outcome and need of assisted ventilation supporting the use of macrophage phenotyping as novel prognostic biomarker in patients with SARS-Cov-2 infection. Finally, the definition of the transcriptomic signature of peripheral blood and tissue-derived myeloid cell subtypes will offer new therapeutic target of this uncurable newly discovered infection.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Immune-phenotyping of tissue and peripheral blood myeloid compartment
- Keywords
- bronchoalveolar lavage fluid, peripheral blood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune-phenotyping of tissue and peripheral blood myeloid compartmentOther
Peripheral blood sampling and bronchoalveolar lavage fluid collection based on the clinical indication at baseline (T0) and peripheral blood sample at the time of clinical worsening/improvement during the follow-up (T1). Moreover, after complete recovery and discharge from the hospital peripheral blood sampling in the outpatient clinical assessment will be performed (T2).
BALF and peripheral blood will be processed for immune-phenotyping of the myeloid compartment using single-cell RAN sequencing analysis.
| Study group | Role | What they receive |
|---|---|---|
| SARS-Cov-2pos pneumonia with moderate/severe lung manifestations with clinical worsening | (PaO2/FiO2<200) Receives: Other: Immune-phenotyping of tissue and peripheral blood myeloid compartment | |
| SARS-Cov-2pos pneumonia with moderate/severe lung manifestations with clinical improvement | (PaO2/FiO2>200) Receives: Other: Immune-phenotyping of tissue and peripheral blood myeloid compartment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement as shown by PaO2/FiO2>200
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start30 May 2020
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alivernini Stefano, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767853
- Sponsor's protocol ID
- 3213
- Status last verified
- Mar 2023
- First submitted
- 2 Mar 2023
- Last updated
- 14 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric Assessment of Peripheral Blood and Tissue Myeloid Cells Phenotype Associated With Severe Lung Manifestations and Cytokines Storm for Precision Medicine in Patients With SARS-Cov-2 Infection.
- ClinicalTrials.gov ID
- NCT05767853
- Acronym / sponsor ID
- 3213
- Conditions
- COVID-19 Pneumonia
- Keywords
- bronchoalveolar lavage fluid, peripheral blood
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 30 May 2020 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 14 Mar 2023 (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.
We hypothesise that patients with SARS-Cov-2 infection are characterized by progressive changes in distribution of distinct lung macrophages populations mediated by influx of circulating monocytes into the lungs . Moreover, we also hypothesise that patients with higher rate of MerTKpos alveolar macrophages in the lung lavage will have the lowest rate of lung complications and the best recovery outcome in terms of clinical outcome and need of assisted ventilation supporting the use of macrophage phenotyping as novel prognostic biomarker in patients with SARS-Cov-2 infection. Finally, the definition of the transcriptomic signature of peripheral blood and tissue-derived myeloid cell subtypes will offer new therapeutic target of this uncurable newly discovered infection.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SARS-Cov-2pos pneumonia with moderate/severe lung manifestations with clinical worsening | – | Other: Immune-phenotyping of tissue and peripheral blood myeloid compartment(PaO2/FiO2<200) |
| SARS-Cov-2pos pneumonia with moderate/severe lung manifestations with clinical improvement | – | Other: Immune-phenotyping of tissue and peripheral blood myeloid compartment(PaO2/FiO2>200) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients hospedalized for Covid-19 pneumonia.
Key inclusion criteria (1 listed)
- Patients with COVID-19 pneumonia
Key exclusion criteria (3 listed)
- Other infections rather than Covid-19
- Patients with concomitant treatment with prednisone ≥10 mg daily
- Patients under therapy with immunosuppressants
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 |
|---|---|---|
| Immune-phenotyping of tissue and peripheral blood myeloid compartmentPeripheral blood sampling and bronchoalveolar lavage fluid collection based on the clinical indication at baseline (T0) and peripheral blood sample at the time of clinical worsening/improvement during the follow-up (T1). Moreover, after complete recovery and discharge from the hospital peripheral blood sampling in the outpatient clinical assessment will be performed (T2). BALF and peripheral blood will be processed for immune-phenotyping of the myeloid compartment using single-cell RAN sequencing analysis. | Other | SARS-Cov-2pos pneumonia with moderate/severe lung manifestations with clinical improvement, SARS-Cov-2pos pneumonia with moderate/severe lung manifestations with clinical worsening |
Primary outcome
Clinical improvement as shown by PaO2/FiO2>200
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pneumonia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites in 2 countries.
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 1 inclusion and 3 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 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, United Kingdom. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement as shown by PaO2/FiO2>200 (time frame: 28 days). 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 14 Mar 2023.