COVIDSequelaeCovNCT04435327
Lung Damage Caused by SARS-CoV-2 Pneumonia (COVID-19)
An observational study of COVID and Pneumonia, Viral, run by University of Milano Bicocca at 1 site in Italy.
Trial summary
Pneumonia is a recurrent element of COVID-19 infection, it is often associated with development of respiratory failure and patients frequently need various degrees of oxygen therapy up to non invasive ventilation (NIV-CPAP) and invasive mechanical ventilation (IMV). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID, Pneumonia, Viral, Barotrauma
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 5 Oct 2020to 18 Mar 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with respiratory failure (P/F < 300) due to SARS-CoV-2 pneumonia
Who may be able to join
- Age ≥ 18 and ≤ 80 years
- Able to sign informed consent to participate in the study
- Real time PCR diagnosis od SARS-CoV-2 infection
- Hospital admission due to clinical/instrumental diagnosis of interstitial pneumonia
- Presence of acute respiratory failure (PaO2/FiO2 <300 mm Hg) at the moment of hospital admission
Who cannot join
- Severe renal failure defined as glomerular filtration rate (GFR) < 30 ml/min at hospital discharge
- Cardiovascular failure NYHA class IV (patient unable to perform any activity) at hospital discharge
- Active solid or hematological malignancies at hospital discharge
- Prior diagnosis of chronic obstructive pulmonary disease (COPD), pulmonary emphysema, pulmonary fibrosis, bronchiectasis associated or not associated to cystic fibrosis
- Pregnancy or breastfeeding
- Suspected bacterial or fungine pulmonary superinfection during hospital stay
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SequelaeCov: a Prospective Study on Lung Damage Caused by SARS-CoV-2 Pneumonia
Pneumonia is a recurrent element of COVID-19 infection, it is often associated with development of respiratory failure and patients frequently need various degrees of oxygen therapy up to non invasive ventilation (NIV-CPAP) and invasive mechanical ventilation (IMV).
Main purpose of this study is to evaluate with non invasive clinical instruments (pletysmography, Diffusion lung capacity for carbon monoxide -DLCO-, six minute walking test and dyspnea scores) and radiological tools (chest X-ray and chest CT scan) the development of medium-to-long term pulmonary sequelae caused by SARS-CoV-2 pneumonia.
Read the detailed description
SARS-CoV-2 related disease started in December 2019 in the Chinese city of Wuhan, rapidly spread and became an international health emergency.
Pneumonia is a frequent element of COVID-19, its pathogenic mechanisms are not entirely known and some patients develop various degrees of respiratory failure and need oxygen therapy up to NIV-CPAP) and IMV.
Some pathology studies in COVID-19 pneumonia show ARDS-like lesions associated to inflammatory reaction. It is known that pulmonary inflammatory damage can lead to fibrotic sequelae or to the development of pulmonary emphysema.
The main target of the study is to use non invasive methods (pletysmography, DLCO assessment, six minute walking test and dyspnea scores) and radiological tools (chest X-ray and chest CT scan) to identify pulmonary sequelae in patients hospitalised because of respiratory failure in COVID-19 pneumonia.
Study design: multicentre observational cohort study. Patients will be divided in three arms according to maximum ventilatory/oxygen support received during hospital stay:
- patients who received only oxygen therapy
- patients who received non invasive ventilation (NIV-CPAP)
- patients who received invasive mechanical ventilation (IMV)
All patients undergo a clinical evaluation at 6 months from hospital discharge (T1) and a second clinical evaluation at 12 months from hospital discharge (T2).
During (T1) patients undergo spirometry with pletysmography and DLCO assessment, six minute walking test, standard chest X-ray, arterial blood gas analysis if SaO2 < 93% in room air, dyspnea score and presence and extension of lung sounds at pulmonary auscultation.
During (T2) patients will undergo spirometry with pletysmography and DLCO assessment, six minute walking test, High Resolution CT scan (HRTC) of the thorax, arterial blood gas analysis if SaO2 < 93% in room air, dyspnea score and presence and extension of lung sounds at pulmonary auscultation).
- Conditions
- COVID, Pneumonia, Viral, Barotrauma, Interstitial Lung Disease, Bronchiectasis Adult, Emphysema
- Medical subject headings
- Pneumonia, Viral, Barotrauma, Lung Diseases, Interstitial, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Oxygen therapy | Patients who were hospitalised due to COVID-19 pneumonia and received only oxygen support therapy. | |
| Non invasive ventilation (NIV/CPAP) | Patients who were hospitalised due to COVID-19 pneumonia and received non invasive ventilation (NIV/CPAP) as maximum support therapy | |
| Invasive ventilation | Patients who were hospitalised due to COVID-19 pneumonia and received invasive mechanical ventilation (IMV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Diffusion of Lung CO (DLCO, single breath technique)
Reduction below 80% of predicted values of DLCO
Measured: T1 at 6 months from discharge
Reduction of Diffusion of Lung CO (DLCO, single breath technique)
Reduction below 80% of predicted values of DLCO
Measured: T2 at 12 months from discharge
Secondary outcomes (42)
Alterations in 6 minute walking test (6MWT)
reduction in maximum distance walked
Measured: T1 at 6 months from discharge
Alterations in 6 minute walking test (6MWT)
reduction in maximum distance walked
Measured: T2 at 12 months from discharge
Alterations in 6 minute walking test (6MWT)
reduction in oxygen saturation nadir
Measured: T1 at 6 months from discharge
Alterations in 6 minute walking test (6MWT)
reduction in oxygen saturation nadir
Measured: T2 at 12 months from discharge
Alterations of pletismography
reduction of Forced Vital Capacity (FVC, %)
Measured: T1 at 6 months from discharge
Alterations of pletismography
reduction of Forced Vital Capacity (FVC, %)
Measured: T2 at 12 months from discharge
Alterations of pletismography
reduction of Forced Vital Capacity (FVC, L)
Measured: T1 at 6 months from discharge
Alterations of pletismography
reduction of Forced Vital Capacity (FVC, L)
Measured: T2 at 12 months from discharge
Alterations of pletismography
reduction of Vital Capacity (VC, %)
Measured: T1 at 6 months from discharge
Alterations of pletismography
reduction of Vital Capacity (VC, %)
Measured: T2 at 12 months from discharge
Alterations of pletismography
reduction of Vital Capacity (VC, L)
Measured: T1 at 6 months from discharge
Alterations of pletismography
reduction of Vital Capacity (VC, L)
Measured: T2 at 12 months from discharge
Alterations of pletismography
reduction of Forced Expiratory Volume in the 1st second (FEV1, L)
Measured: T1 at 6 months from discharge
Alterations of pletismography
reduction of Forced Expiratory Volume in the 1st second (FEV1, %)
Measured: T1 at 6 months from discharge
Alterations of pletismography
reduction of Forced Expiratory Volume in the 1st second (FEV1, L)
Measured: T2 at 12 months from discharge
Alterations of pletismography
reduction of Forced Expiratory Volume in the 1st second (FEV1, L%)
Measured: T2 at 12 months from discharge
Alterations of pletismography
reduction of Total Lung Capacity (TLC, L)
Measured: T1 at 6 months from discharge
Alterations of pletismography
reduction of Total Lung Capacity (TLC, %)
Measured: T1 at 6 months from discharge
Alterations of pletismography
reduction of Total Lung Capacity (TLC, L)
Measured: T2 at 12 months from discharge
Alterations of pletismography
reduction of Total Lung Capacity (TLC, %)
Measured: T2 at 12 months from discharge
Alterations of pletismography
alterations of Residual Volume (RV,%)
Measured: T1 at 6 months from discharge
Alterations of pletismography
alterations of Residual Volume (RV, L)
Measured: T1 at 6 months from discharge
Alterations of pletismography
alterations of Residual Volume (RV, L)
Measured: T2 at 12 months from discharge
Alterations of pletismography
alterations of Residual Volume (RV, %)
Measured: T2 at 12 months from discharge
Alterations of pletismography
increase of Specific Airway Resistance (sRAW) (absolute value)
Measured: T1 at 6 months from discharge
Alterations of pletismography
increase of Specific Airway Resistance (sRAW) (%)
Measured: T1 at 6 months from discharge
Alterations of pletismography
increase of Specific Airway Resistance (sRAW) (absolute value)
Measured: T2 at 12 months from discharge
Alterations of pletismography
increase of Specific Airway Resistance (sRAW) (%)
Measured: T2 at 12 months from discharge
Alterations of pletismography
alterations of Motley Index (VR/CPT)
Measured: T1 at 6 months from discharge
Alterations of pletismography
alterations of Motley Index (VR/CPT)
Measured: T2 at 12 months from discharge
Alterations of pletismography
alterations of Tiffeneau Index (IT)
Measured: T1 at 6 months from discharge
Alterations of pletismography
alterations of Tiffeneau Index (IT)
Measured: T2 at 12 months from discharge
Alterations of Arterial Blood Gas Analysis
reduction of PaO2 mmHg
Measured: T1 at 6 months from discharge
Alterations of Arterial Blood Gas Analysis
reduction of PaO2 mmHg
Measured: T2 at 12 months from discharge
Alterations of Arterial Blood Gas Analysis
alteration of PaCO2 mmHg
Measured: T1 at 6 months from discharge
Alterations of Arterial Blood Gas Analysis
alteration of PaCO2 mmHg
Measured: T2 at 12 months from discharge
Abnormal Dyspnea Score
Modified Medical Research Council - mMRC > 0 (minimum 0, maximum 4; higher score means worse outcome)
Measured: T1 at 6 months from discharge
Abnormal Dyspnea Score
Modified Medical Research Council - mMRC > 0(minimum 0, maximum 4; higher score means worse outcome)
Measured: T2 at 12 months from discharge
Presence and extension of abnormal pulmonary lung sounds at auscultation
Presence and extension of abnormal pulmonary lung sounds at auscultation
Measured: T1 at 6 months from discharge
Presence and extension of abnormal pulmonary lung sounds at auscultation
Presence and extension of abnormal pulmonary lung sounds at auscultation
Measured: T2 at 12 months from discharge
Presence and extension of radiological alterations at chest X-ray
Presence and extension of radiological alterations at chest X-ray
Measured: T1 at 6 months from discharge
Presence and extension of radiological alterations at chest CT scan
Presence and extension of radiological alterations at chest CT scan
Measured: T2 at 12 months from discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start5 Oct 2020
- Primary completion31 Dec 2021
- Study completion18 Mar 2022
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 COVIDStudies 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435327
- Sponsor's protocol ID
- SequelaeCov
- Acronym
- SequelaeCov
- Status last verified
- Jan 2022
- First submitted
- 12 Jun 2020
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Faverio P, Luppi F, Rebora P, Busnelli S, Stainer A, Catalano M, Parachini L, Monzani A, Galimberti S, Bini F, Bodini BD, Betti M, De Giacomi F, Scarpazza P, Oggionni E, Scartabellati A, Bilucaglia L, Ceruti P, Modina D, Harari S, Caminati A, Valsecchi MG, Bellani G, Foti G, Pesci A. Six-Month Pulmonary Impairment after Severe COVID-19: A Prospective, Multicentre Follow-Up Study. Respiration. 2021;100(11):1078-1087. doi: 10.1159/000518141. Epub 2021 Aug 19.
PubMed 34515212
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SequelaeCov: a Prospective Study on Lung Damage Caused by SARS-CoV-2 Pneumonia
- ClinicalTrials.gov ID
- NCT04435327
- Acronym / sponsor ID
- SequelaeCov / SequelaeCov
- Conditions
- COVID, Pneumonia, Viral, Barotrauma, Interstitial Lung Disease, Bronchiectasis Adult, Emphysema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 18 Mar 2022 (actual)
- First posted
- 17 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.
Pneumonia is a recurrent element of COVID-19 infection, it is often associated with development of respiratory failure and patients frequently need various degrees of oxygen therapy up to non invasive ventilation (NIV-CPAP) and invasive mechanical ventilation (IMV).
Main purpose of this study is to evaluate with non invasive clinical instruments (pletysmography, Diffusion lung capacity for carbon monoxide -DLCO-, six minute walking test and dyspnea scores) and radiological tools (chest X-ray and chest CT scan) the development of medium-to-long term pulmonary sequelae caused by SARS-CoV-2 pneumonia.
Detailed description
SARS-CoV-2 related disease started in December 2019 in the Chinese city of Wuhan, rapidly spread and became an international health emergency.
Pneumonia is a frequent element of COVID-19, its pathogenic mechanisms are not entirely known and some patients develop various degrees of respiratory failure and need oxygen therapy up to NIV-CPAP) and IMV.
Some pathology studies in COVID-19 pneumonia show ARDS-like lesions associated to inflammatory reaction. It is known that pulmonary inflammatory damage can lead to fibrotic sequelae or to the development of pulmonary emphysema.
The main target of the study is to use non invasive methods (pletysmography, DLCO assessment, six minute walking test and dyspnea scores) and radiological tools (chest X-ray and chest CT scan) to identify pulmonary sequelae in patients hospitalised because of respiratory failure in COVID-19 pneumonia.
Study design: multicentre observational cohort study. Patients will be divided in three arms according to maximum ventilatory/oxygen support received during hospital stay:
- patients who received only oxygen therapy
- patients who received non invasive ventilation (NIV-CPAP)
- patients who received invasive mechanical ventilation (IMV)
All patients undergo a clinical evaluation at 6 months from hospital discharge (T1) and a second clinical evaluation at 12 months from hospital discharge (T2).
During (T1) patients undergo spirometry with pletysmography and DLCO assessment, six minute walking test, standard chest X-ray, arterial blood gas analysis if SaO2 < 93% in room air, dyspnea score and presence and extension of lung sounds at pulmonary auscultation.
During (T2) patients will undergo spirometry with pletysmography and DLCO assessment, six minute walking test, High Resolution CT scan (HRTC) of the thorax, arterial blood gas analysis if SaO2 < 93% in room air, dyspnea score and presence and extension of lung sounds at pulmonary auscultation).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oxygen therapy | – | –Patients who were hospitalised due to COVID-19 pneumonia and received only oxygen support therapy. |
| Non invasive ventilation (NIV/CPAP) | – | –Patients who were hospitalised due to COVID-19 pneumonia and received non invasive ventilation (NIV/CPAP) as maximum support therapy |
| Invasive ventilation | – | –Patients who were hospitalised due to COVID-19 pneumonia and received invasive mechanical ventilation (IMV) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with respiratory failure (P/F < 300) due to SARS-CoV-2 pneumonia
Key inclusion criteria (5 listed)
- Age ≥ 18 and ≤ 80 years
- Able to sign informed consent to participate in the study
- Real time PCR diagnosis od SARS-CoV-2 infection
- Hospital admission due to clinical/instrumental diagnosis of interstitial pneumonia
- Presence of acute respiratory failure (PaO2/FiO2 <300 mm Hg) at the moment of hospital admission
Key exclusion criteria (6 listed)
- Severe renal failure defined as glomerular filtration rate (GFR) < 30 ml/min at hospital discharge
- Cardiovascular failure NYHA class IV (patient unable to perform any activity) at hospital discharge
- Active solid or hematological malignancies at hospital discharge
- Prior diagnosis of chronic obstructive pulmonary disease (COPD), pulmonary emphysema, pulmonary fibrosis, bronchiectasis associated or not associated to cystic fibrosis
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reduction of Diffusion of Lung CO (DLCO, single breath technique)
Time frame: T1 at 6 months from discharge
Reduction below 80% of predicted values of DLCO
Reduction of Diffusion of Lung CO (DLCO, single breath technique)
Time frame: T2 at 12 months from discharge
Reduction below 80% of predicted values of DLCO
42 secondary outcomes
Alterations in 6 minute walking test (6MWT)
Time frame: T1 at 6 months from discharge
Alterations in 6 minute walking test (6MWT)
Time frame: T2 at 12 months from discharge
Alterations in 6 minute walking test (6MWT)
Time frame: T1 at 6 months from discharge
Alterations in 6 minute walking test (6MWT)
Time frame: T2 at 12 months from discharge
Alterations of pletismography
Time frame: T1 at 6 months from discharge
Alterations of pletismography
Time frame: T2 at 12 months from discharge
Alterations of pletismography
Time frame: T1 at 6 months from discharge
Alterations of pletismography
Time frame: T2 at 12 months from discharge
Alterations of pletismography
Time frame: T1 at 6 months from discharge
Alterations of pletismography
Time frame: T2 at 12 months from discharge
Alterations of pletismography
Time frame: T1 at 6 months from discharge
Alterations of pletismography
Time frame: T2 at 12 months from discharge
Alterations of pletismography
Time frame: T1 at 6 months from discharge
Alterations of pletismography
Time frame: T1 at 6 months from discharge
Alterations of pletismography
Time frame: T2 at 12 months from discharge
Alterations of pletismography
Time frame: T2 at 12 months from discharge
Alterations of pletismography
Time frame: T1 at 6 months from discharge
Alterations of pletismography
Time frame: T1 at 6 months from discharge
Alterations of pletismography
Time frame: T2 at 12 months from discharge
Alterations of pletismography
Time frame: T2 at 12 months from discharge
Alterations of pletismography
Time frame: T1 at 6 months from discharge
Alterations of pletismography
Time frame: T1 at 6 months from discharge
Alterations of pletismography
Time frame: T2 at 12 months from discharge
Alterations of pletismography
Time frame: T2 at 12 months from discharge
Alterations of pletismography
Time frame: T1 at 6 months from discharge
Alterations of pletismography
Time frame: T1 at 6 months from discharge
Alterations of pletismography
Time frame: T2 at 12 months from discharge
Alterations of pletismography
Time frame: T2 at 12 months from discharge
Alterations of pletismography
Time frame: T1 at 6 months from discharge
Alterations of pletismography
Time frame: T2 at 12 months from discharge
Alterations of pletismography
Time frame: T1 at 6 months from discharge
Alterations of pletismography
Time frame: T2 at 12 months from discharge
Alterations of Arterial Blood Gas Analysis
Time frame: T1 at 6 months from discharge
Alterations of Arterial Blood Gas Analysis
Time frame: T2 at 12 months from discharge
Alterations of Arterial Blood Gas Analysis
Time frame: T1 at 6 months from discharge
Alterations of Arterial Blood Gas Analysis
Time frame: T2 at 12 months from discharge
Abnormal Dyspnea Score
Time frame: T1 at 6 months from discharge
Abnormal Dyspnea Score
Time frame: T2 at 12 months from discharge
Presence and extension of abnormal pulmonary lung sounds at auscultation
Time frame: T1 at 6 months from discharge
Presence and extension of abnormal pulmonary lung sounds at auscultation
Time frame: T2 at 12 months from discharge
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 4 May 2022.
- Results publication: PubMed 34515212Faverio P, Luppi F, Rebora P, Busnelli S, Stainer A, Catalano M, Parachini L, Monzani A, Galimberti S, Bini F, Bodini BD, Betti M, De Giacomi F, Scarpazza P, Oggionni E, Scartabellati A, Bilucaglia L, Ceruti P, Modina D, Harari S, Caminati A, Valsecchi MG, Bellani G, Foti G, Pesci A. Six-Month Pulmonary Impairment after Severe COVID-19: A Prospective, Multicentre Follow-Up Study. Respiration. 2021;100(11):1078-1087. doi: 10.1159/000518141. Epub 2021 Aug 19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COVID and Pneumonia, Viral, run by University of Milano Bicocca at 1 site in Italy.
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 5 inclusion and 6 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 4 May 2022. 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 Italy. 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?
Reduction of Diffusion of Lung CO (DLCO, single breath technique) (time frame: T1 at 6 months from discharge). 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?
On the ClinicalTrials.gov record for NCT04435327, 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 4 May 2022.