Covid-19; SARS-Cov2MyeloidCovidNCT04590261
Myeloid Cells in Patients With Covid-19 Pneumonia
A study testing Blood sampling and Nasal Brushing in people with Covid-19; SARS-Cov2, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
The purpose of this study is to analyze in depth the relationship of myeloid cell subpopulations during infection by Severe acute respiratory syndrome coronavirus 2 (SARS-Cov2), the virus mediating Covid-19. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid-19; SARS-Cov2
- What is being tested?
- Blood sampling and Nasal Brushing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 28 Sep 2023to 28 Sep 2023
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Sex : male or female
- French Social Security insurance
- Information and consent dated and signed *
- Group 1 : inclusion 2 to 12 months after hospitalization for Covid-19 pneumonia with mild severity (oxygen treatment ≤5L/mn);
- Group 2 : 2 to 12 months after hospitalization for Covid-19 pneumonia with high severity (oxygen treatment >5L/mn);
- Group 3 : external visit at Cochin Hospital, age- and sex -matched with Groups 1, 2, 4.
- Group 4 : inclusion during hospitalization for Covid-19, within the first month of symptoms.
Who cannot join
- Tuberculosis or other evolutive bacterial infection
- Chronic evolutive viral Infections (Hepatitis B or C, HIV)
- Ongoing chemotherapy or radiotherapy
- Participation in another research protocol with current exclusion period at the time of pre-inclusion (possible inclusion in an observational study
- Vulnerable person (pregnant, parturient woman, breastfeeding woman, person Under tutorship, person under arrest through judiciary or administrative decision )
About this study
The purpose of this study is to analyze in depth the relationship of myeloid cell subpopulations during infection by Severe acute respiratory syndrome coronavirus 2 (SARS-Cov2), the virus mediating Covid-19. Myeloid cells include neutrophils, monocytes and dendritic cells, each divided into subpopulations with different functions in immune defense and immune pathologies.
The study is based on the following hypotheses:
- Infection and the interferon response to infection may induce hyperactive or immunosuppressive differentiation of myeloid cells, that may be treated by specific inhibitors.
- Some myeloid cell subpopulations currently identified in our laboratories might be markers for Covid-19 prognosis.
- Alternative receptors may be present on myeloid cells, inducing the cytokine storm, a target for therapy.
- The expression of Interferon (IFN) receptor and IFN responding genes on myeloid cells and on respiratory epithelial cells may correlate with prognosis and indicate potential treatment targets.
- Interferon responses are known to be skewed during Covid-19, but some IFN subtype polymorphisms may correlate with prognosis and these subtypes migt be supplemented or inhibited for therapy.
Read the detailed description
Infection by SARS-Cov2 drives to pneumonia in most cases, 30 percent of which require hospitalization in a pneumology ward, among which 30 percent with severe acute respiratory syndrome (SARS) must go to critical care units, with a high mortality rate.
This infection drives a strong cytokine response. In patients developing SARS, a profound, paradoxical defect in IFN alpha and in the expression of genes responding to IFN alpha was discovered. IFNs are strong anti-viral proteins, used for the treatment of viral hepatitis. Type I IFNs, including IFN alpha, have ubiquitous receptors on almost every cell type. Type III IFNs, or IFN lambda, have a more restricted receptor expression, including on neutrophils. Their polymorphisms were already related to the prognosis of another ribonucleic acid (RNA) virus with mucosal entry, hepatitis C virus (HCV), especially in people with African origins.
Coronaviruses responsible for the previous SARS-Cov or Middle East respiratory syndrome coronavirus (MERS-Cov) epidemics induce a defective IFN signal transduction. Many other viral infection lead to desensitization. Moreover, IFN alpha by itself can lead to defective antiviral responses. At the immune cell level, lymphopenia with an increased neutrophil/lymphocyte ratio were noted in severe SARS-Cov2 case. New subpopulations of neutrophils have been characterized by phenotypic and proteomic studies, with inflammatory or suppressive functions.
It will be important to know if
- hyperactive or immunosuppressive myeloid cell differentiation is caused by SARS-Cov2 and can be inhibited specifically.
- some myeloid subpopulations
- correlate with the prognosis of the disease,
- myeloid cells have alternative receptors for SARS-Cov2,
- some IFN polymorphisms may correlate with prognosis and might be supplemented or inhibited for therapy.
The answers will be obtained through the primary and secondary outcome measures, as described below.
- Conditions
- Covid-19; SARS-Cov2
- Being tested
- Blood sampling, Nasal Brushing
- Keywords
- Covid-19, Neutrophils, Dendritic cells, Monocytes, Macrophages, Interferons, Nasal mucosa, Peripheral blood, Pneumonia
- Medical subject headings
- COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Peripheral Blood sampling, 25 mL
Nasal BrushingOther
Nasal Brushing, facultative
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Other | Former mild SARS-Cov2 Pneumonia, 2 to 12 moths before, ≤ 5 L/mn Oxygen treatment Receives: Other: Blood sampling; Other: Nasal Brushing |
| Group 2 | Other | Former severe SARS-Cov2 Pneumonia, 2 to 12 moths before, > 5 L/mn Oxygen treatment Receives: Other: Blood sampling; Other: Nasal Brushing |
| Group 3 | Other | Physician examination in the Pneumology ward, Cochin Hospital Receives: Other: Blood sampling; Other: Nasal Brushing |
| Group 4 | Other | Current hospitalization for Sars-Cov2 Pneumonia at Cochin Hospital Receives: Other: Blood sampling; Other: Nasal Brushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myeloid cell sub-population phenotype
Cytometric analysis of surface and intracellular molecules to identify myeloid cell sub-populations and define their function in vivo
Measured: Month zero-month 36
Secondary outcomes (4)
Myeloid cell functions
Cell culture and cytometric and analyte analysis of their functions, including IFN production
Measured: Month zero-month 36
Myeloid cell transcriptomic and proteomic study
Transcriptomic and proteomic analysis of the functions of myeloid cell subtypes
Measured: Month zero-month 36
Transcriptomic study of nasal epithelial cells
Single cell RNA sequencing of the nasal brush products
Measured: Month zero-month 36
Plasma analyte concentration measurement
High sensitivity detection by state-of-the art ELISA type methods
Measured: Month zero-month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start28 Sep 2023
- Primary completion28 Sep 2023
- Study completion28 Sep 2023
Why it stopped: The request for an extension was ultimately denied by the CPP because it was submitted after the deadline (the dates on the portal were incorrects).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19; SARS-Cov2Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Pierre-Régis Burgel, MD, PhD, Principal investigator, Cochin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590261
- Sponsor's protocol ID
- APHP201138
- Other IDs
- 2020-A02700-39
- Acronym
- MyeloidCovid
- Status last verified
- Jul 2026
- First submitted
- 15 Oct 2020
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myeloid Cells in Patients With Covid-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04590261
- Acronym / sponsor ID
- MyeloidCovid / APHP201138
- Conditions
- Covid-19; SARS-Cov2
- Keywords
- Covid-19, Neutrophils, Dendritic cells, Monocytes, Macrophages, Interferons, Nasal mucosa, Peripheral blood
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The request for an extension was ultimately denied by the CPP because it was submitted after the deadline (the dates on the portal were incorrects).
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, URC-CIC Paris Descartes Necker Cochin
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 19 Oct 2020 (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.
The purpose of this study is to analyze in depth the relationship of myeloid cell subpopulations during infection by Severe acute respiratory syndrome coronavirus 2 (SARS-Cov2), the virus mediating Covid-19. Myeloid cells include neutrophils, monocytes and dendritic cells, each divided into subpopulations with different functions in immune defense and immune pathologies.
The study is based on the following hypotheses:
- Infection and the interferon response to infection may induce hyperactive or immunosuppressive differentiation of myeloid cells, that may be treated by specific inhibitors.
- Some myeloid cell subpopulations currently identified in our laboratories might be markers for Covid-19 prognosis.
- Alternative receptors may be present on myeloid cells, inducing the cytokine storm, a target for therapy.
- The expression of Interferon (IFN) receptor and IFN responding genes on myeloid cells and on respiratory epithelial cells may correlate with prognosis and indicate potential treatment targets.
- Interferon responses are known to be skewed during Covid-19, but some IFN subtype polymorphisms may correlate with prognosis and these subtypes migt be supplemented or inhibited for therapy.
Detailed description
Infection by SARS-Cov2 drives to pneumonia in most cases, 30 percent of which require hospitalization in a pneumology ward, among which 30 percent with severe acute respiratory syndrome (SARS) must go to critical care units, with a high mortality rate.
This infection drives a strong cytokine response. In patients developing SARS, a profound, paradoxical defect in IFN alpha and in the expression of genes responding to IFN alpha was discovered. IFNs are strong anti-viral proteins, used for the treatment of viral hepatitis. Type I IFNs, including IFN alpha, have ubiquitous receptors on almost every cell type. Type III IFNs, or IFN lambda, have a more restricted receptor expression, including on neutrophils. Their polymorphisms were already related to the prognosis of another ribonucleic acid (RNA) virus with mucosal entry, hepatitis C virus (HCV), especially in people with African origins.
Coronaviruses responsible for the previous SARS-Cov or Middle East respiratory syndrome coronavirus (MERS-Cov) epidemics induce a defective IFN signal transduction. Many other viral infection lead to desensitization. Moreover, IFN alpha by itself can lead to defective antiviral responses. At the immune cell level, lymphopenia with an increased neutrophil/lymphocyte ratio were noted in severe SARS-Cov2 case. New subpopulations of neutrophils have been characterized by phenotypic and proteomic studies, with inflammatory or suppressive functions.
It will be important to know if
- hyperactive or immunosuppressive myeloid cell differentiation is caused by SARS-Cov2 and can be inhibited specifically.
- some myeloid subpopulations
- correlate with the prognosis of the disease,
- myeloid cells have alternative receptors for SARS-Cov2,
- some IFN polymorphisms may correlate with prognosis and might be supplemented or inhibited for therapy.
The answers will be obtained through the primary and secondary outcome measures, as described below.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 1 | Other | Other: Blood sampling, Other: Nasal BrushingFormer mild SARS-Cov2 Pneumonia, 2 to 12 moths before, ≤ 5 L/mn Oxygen treatment |
| Group 2 | Other | Other: Blood sampling, Other: Nasal BrushingFormer severe SARS-Cov2 Pneumonia, 2 to 12 moths before, > 5 L/mn Oxygen treatment |
| Group 3 | Other | Other: Blood sampling, Other: Nasal BrushingPhysician examination in the Pneumology ward, Cochin Hospital |
| Group 4 | Other | Other: Blood sampling, Other: Nasal BrushingCurrent hospitalization for Sars-Cov2 Pneumonia at Cochin Hospital |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years
- Sex : male or female
- French Social Security insurance
- Information and consent dated and signed *
- Group 1 : inclusion 2 to 12 months after hospitalization for Covid-19 pneumonia with mild severity (oxygen treatment ≤5L/mn);
Key exclusion criteria (5 listed)
- Tuberculosis or other evolutive bacterial infection
- Chronic evolutive viral Infections (Hepatitis B or C, HIV)
- Ongoing chemotherapy or radiotherapy
- Participation in another research protocol with current exclusion period at the time of pre-inclusion (possible inclusion in an observational study
- Vulnerable person (pregnant, parturient woman, breastfeeding woman, person Under tutorship, person under arrest through judiciary or administrative decision )
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 |
|---|---|---|
| Blood samplingPeripheral Blood sampling, 25 mL | Other | Group 2, Group 3, Group 4, group 1 |
| Nasal BrushingNasal Brushing, facultative | Other | Group 2, Group 3, Group 4, group 1 |
Primary outcome
Myeloid cell sub-population phenotype
Time frame: Month zero-month 36
Cytometric analysis of surface and intracellular molecules to identify myeloid cell sub-populations and define their function in vivo
4 secondary outcomes
Myeloid cell functions
Time frame: Month zero-month 36
Myeloid cell transcriptomic and proteomic study
Time frame: Month zero-month 36
Transcriptomic study of nasal epithelial cells
Time frame: Month zero-month 36
Plasma analyte concentration measurement
Time frame: Month zero-month 36
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Team NiedergangLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Pierre-Régis Burgel, MD, PhD principal investigator
Cochin Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling and Nasal Brushing in people with Covid-19; SARS-Cov2, run by Assistance Publique - Hôpitaux de Paris.
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 8 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: withdrawn, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myeloid cell sub-population phenotype (time frame: Month zero-month 36). 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 20 Jul 2026.