Pneumonia, ViralPULCO-19NCT04422613
Characterization of Persistent Pulmonary Abnormalities Following COVID-19 Pneumonia
A study testing pulmonary anomalies 4 months after documented COVID-19 pneumonia in people with Pneumonia, Viral, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Severe Acute Respiratory Syndrome (SARS) SARS-CoV-2, name of the Coronavirus Group of international Committee on taxonomy of viruses, is an emerging virus from the family of coronaviridae, responsible for the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Viral
- What is being tested?
- pulmonary anomalies 4 months after documented COVID-19 pneumonia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- 28 May 2020to 29 Oct 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with COVID-19 pneumonia
- Positive PCR for COVID-19 on respiratory sample (saliva, nasopharyngeal, bronchial, tracheal aspiration or LBA)
- Having required hospitalization in the pulmonology service, intensive care in pneumology or resuscitation service at the Toulouse University Hospital
- Saturation <94% in ambient air at diagnosis
- Patient having a chest CT-scan proving pneumonia during his hospitalization
- Patient ≥ 18 years old
- Patient who has given written consent to participate in the study
Who cannot join
- Patient hospitalized for pneumonia not documented by a chest CT-scan
- Patient with negative COVID PCR
- Patient known before the episode of COVID-19 pneumonia for a respiratory or cardiac pathology which can lead in itself to an alteration of gas exchanges
- Patient under curators / guardianship
- Pregnant patient
- Minor patient
- Absence of consent for participation in the study
- Medical condition that does not allow for pulmonary function test
Trial locations and contacts
1 site in 1 country.
About this study
Severe Acute Respiratory Syndrome (SARS) SARS-CoV-2, name of the Coronavirus Group of international Committee on taxonomy of viruses, is an emerging virus from the family of coronaviridae, responsible for the COVID-19 pandemic. This infection can progress to viral pneumonia, and in 3% of cases up to acute respiratory distress syndrome (ARDS) which conditions the prognosis of the disease.
Due to its unusual clinical presentation with a risk of sudden deterioration on the 8th day as a result of possible hyperinflammatory response, the respiratory impairment of COVID is unique and many questions remain unanswered concerning its evolution once the acute phase has passed. Knowledge of the evolution of pulmonary involvement, particularly in patients requiring hospitalization, can help reduce the morbidity linked to the persistent abnormalities identified by establishing early therapeutic management. It can also provide a better understanding of the mechanisms of pulmonary involvement in the acute phase. Current data regarding the acute phase of COVID-19 suggest that persistent abnormalities remain distant from this infection at all levels of the respiratory system: gas exchange, perfusion, ventilatory mechanics, and interstitial lung disease.
The main objective is to characterize persistent gas exchange anomalies 4 months after documented COVID-19 pneumonia, resulting in oxygen desaturation and requiring hospitalization.
- Conditions
- Pneumonia, Viral
- Being tested
- pulmonary anomalies 4 months after documented COVID-19 pneumonia
- Keywords
- COVID-19, Respiratory Function Tests, Pulmonary Gas Exchange : Respiratory Tract Diseases, Pulmonary Embolism, Respiratory Distress Syndrome
- Medical subject headings
- Pneumonia, Viral, COVID-19, Pulmonary Embolism, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary anomalies 4 months after documented COVID-19 pneumoniaDiagnostic test
Characterization of pulmonary damage with a complete pulmonary assessment 4 months after COVID-19 pneumonia,
| Study group | Role | What they receive |
|---|---|---|
| characterization of pulmonary damage | Experimental | This clinical trial will be characterized the pulmonary damage after COVID-19 pneumonia Receives: Diagnostic Test: pulmonary anomalies 4 months after documented COVID-19 pneumonia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alteration of the DLCO
Alteration of the DLCO test defined by a corrected DLCO value <70% of theoretical and / or desaturation in the 6 Minute Walk Test (loss of 4% or more of SpO2)
Measured: 4 month
Secondary outcomes (7)
Mechanism of the alteration of gas exchanges
The mechanism of the alteration of gas exchanges will be specified by the analysis of the values obtained during the diffusing CO / NO test, at 4 month after COVID- 19 pneumonia
Measured: 4 month
Measurement on lung volumes
The mechanism of the alteration of gas exchanges will be specified by the analysis of the other values obtained during the measurement of lung volumes in respiratory function tests at 4 month after COVID- 19 pneumonia
Measured: 4 month
mechanism of the alteration of gas exchanges by chest scan
The mechanism of the alteration of gas exchanges will be specified by the analysis of the other values obtained during chest CT-scan at 4 month after COVID- 19 pneumonia
Measured: 4 month
mechanism of the alteration of gas exchanges by scintigraphy
The mechanism of the alteration of gas exchanges identified will be specified by the analysis of the other values obtained during pulmonary scintigraphy, at 4 month after COVID- 19 pneumonia :
Measured: 4 month
Respiratory symptom
the existence of respiratory symptoms, defined by dyspnea, cough, sputum, haemoptysis, chest pain, sign of right ventricular failure, sleep disorders or a 6-minute walk test value <80% of theoretical, at 4 month after COVID- 19 pneumonia
Measured: 4 month
Bronchial or ventilatory anomalies
the existence of persistent bronchial or ventilatory anomalies at 4 months, defined on current respiratory function tests (plethysmography, forced oscillometry test, diaphragmatic explorations, measurement of exhaled NO)
Measured: 4 month
Persistent respiratory anomalies
Persistent respiratory anomalies at 4 months will be evaluated at 12 months of the acute episode by an appropriate paraclinical assessment : mechanism of the alteration of gas exchanges, Respiratory symptom and bronchial or ventilatory anomalies will be evaluated
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start28 May 2020
- Primary completion1 Jul 2021
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, ViralStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elise Noël-Savina, MD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422613
- Sponsor's protocol ID
- RC31/20/0181
- Acronym
- PULCO-19
- Status last verified
- Oct 2021
- First submitted
- 5 Jun 2020
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Noel-Savina E, Viatge T, Faviez G, Lepage B, Mhanna LT, Pontier S, Dupuis M, Collot S, Thomas P, Idoate Lacasia J, Crognier L, Bouharaoua S, Silva Sifontes S, Mazieres J, Prevot G, Didier A. Severe SARS-CoV-2 pneumonia: Clinical, functional and imaging outcomes at 4 months. Respir Med Res. 2021 Nov;80:100822. doi: 10.1016/j.resmer.2021.100822. Epub 2021 Apr 28.
PubMed 34242974
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Persistent Pulmonary Abnormalities Following COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04422613
- Acronym / sponsor ID
- PULCO-19 / RC31/20/0181
- Conditions
- Pneumonia, Viral
- Keywords
- COVID-19, Respiratory Function Tests, Pulmonary Gas Exchange : Respiratory Tract Diseases, Pulmonary Embolism, Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 28 May 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 9 Jun 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.
Severe Acute Respiratory Syndrome (SARS) SARS-CoV-2, name of the Coronavirus Group of international Committee on taxonomy of viruses, is an emerging virus from the family of coronaviridae, responsible for the COVID-19 pandemic. This infection can progress to viral pneumonia, and in 3% of cases up to acute respiratory distress syndrome (ARDS) which conditions the prognosis of the disease.
Due to its unusual clinical presentation with a risk of sudden deterioration on the 8th day as a result of possible hyperinflammatory response, the respiratory impairment of COVID is unique and many questions remain unanswered concerning its evolution once the acute phase has passed. Knowledge of the evolution of pulmonary involvement, particularly in patients requiring hospitalization, can help reduce the morbidity linked to the persistent abnormalities identified by establishing early therapeutic management. It can also provide a better understanding of the mechanisms of pulmonary involvement in the acute phase. Current data regarding the acute phase of COVID-19 suggest that persistent abnormalities remain distant from this infection at all levels of the respiratory system: gas exchange, perfusion, ventilatory mechanics, and interstitial lung disease.
The main objective is to characterize persistent gas exchange anomalies 4 months after documented COVID-19 pneumonia, resulting in oxygen desaturation and requiring hospitalization.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| characterization of pulmonary damage | Experimental | Diagnostic Test: pulmonary anomalies 4 months after documented COVID-19 pneumoniaThis clinical trial will be characterized the pulmonary damage after COVID-19 pneumonia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient with COVID-19 pneumonia
- Positive PCR for COVID-19 on respiratory sample (saliva, nasopharyngeal, bronchial, tracheal aspiration or LBA)
- Having required hospitalization in the pulmonology service, intensive care in pneumology or resuscitation service at the Toulouse University Hospital
- Saturation <94% in ambient air at diagnosis
- Patient having a chest CT-scan proving pneumonia during his hospitalization
Key exclusion criteria (8 listed)
- Patient hospitalized for pneumonia not documented by a chest CT-scan
- Patient with negative COVID PCR
- Patient known before the episode of COVID-19 pneumonia for a respiratory or cardiac pathology which can lead in itself to an alteration of gas exchanges
- Patient under curators / guardianship
- Pregnant patient
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 |
|---|---|---|
| pulmonary anomalies 4 months after documented COVID-19 pneumoniaCharacterization of pulmonary damage with a complete pulmonary assessment 4 months after COVID-19 pneumonia, | Diagnostic test | characterization of pulmonary damage |
Primary outcome
Alteration of the DLCO
Time frame: 4 month
Alteration of the DLCO test defined by a corrected DLCO value <70% of theoretical and / or desaturation in the 6 Minute Walk Test (loss of 4% or more of SpO2)
7 secondary outcomes
Mechanism of the alteration of gas exchanges
Time frame: 4 month
Measurement on lung volumes
Time frame: 4 month
mechanism of the alteration of gas exchanges by chest scan
Time frame: 4 month
mechanism of the alteration of gas exchanges by scintigraphy
Time frame: 4 month
Respiratory symptom
Time frame: 4 month
Bronchial or ventilatory anomalies
Time frame: 4 month
Persistent respiratory anomalies
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Results publication: PubMed 34242974Noel-Savina E, Viatge T, Faviez G, Lepage B, Mhanna LT, Pontier S, Dupuis M, Collot S, Thomas P, Idoate Lacasia J, Crognier L, Bouharaoua S, Silva Sifontes S, Mazieres J, Prevot G, Didier A. Severe SARS-CoV-2 pneumonia: Clinical, functional and imaging outcomes at 4 months. Respir Med Res. 2021 Nov;80:100822. doi: 10.1016/j.resmer.2021.100822. Epub 2021 Apr 28.
- 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.
Elise Noël-Savina, MD principal investigator
University Hospital of Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulmonary anomalies 4 months after documented COVID-19 pneumonia in people with Pneumonia, Viral, run by University Hospital, Toulouse at 1 site in France.
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 28 Nov 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Alteration of the DLCO (time frame: 4 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04422613, which also lists 1 linked publication.
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 Nov 2025.