SARS-COV-2 PneumoniaNCT04605757
Long-term Evolution of Pulmonary Involvement of Novel SARS-COV-2 Infection (COVID-19): Follow the Covid Study
An observational study of SARS-COV-2 Pneumonia, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
In December 2019 the first case of human infection by a new coronavirus was identified, currently called SARS-COV-2 (Severe Acute Respiratory Syndrome - Coronavirus - 2), characterized by high contagiousness and the possibility of causing a severe acute respiratory distress syndrome from which its acronym derives and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-COV-2 Pneumonia
- What is being tested?
- Clinical, functional and radiological lung involvement evolution
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jul 2020to 30 Jul 2021
- 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: all patients with SARS-COV-2 pneumonia discharged from our Insitution (Respiratory and Critical Care Unit - S.Orsola-Malpighi University Hospital, Bologna, IT) or patients referred to our Clinic for the followup of SARS-COV-2 pneumonia after hospital stay.
Who may be able to join
- acute respiratory failure due to SARS-COV-2 pneumonia
- sign of informed consent
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Respiratory and Critical Care Unit - S.Orsola-Malpighi University Hospital
Bologna, 40138
Irene Prediletto, MD-Phd, +390512143253, irene.prediletto@aosp.bo.it
Stefano Nava, MD, FERS, +390512143253, stefano.nava@aosp.bo.it
About this study
Official title: Pulmonary Involvement of Novel SARS-COV-2 Infection (COVID-19): Long-term Impact and Predictors of Possible Lasting Damage: Follow the Covid Study
In December 2019 the first case of human infection by a new coronavirus was identified, currently called SARS-COV-2 (Severe Acute Respiratory Syndrome - Coronavirus - 2), characterized by high contagiousness and the possibility of causing a severe acute respiratory distress syndrome from which its acronym derives and which caused the state of a global pandemic in a few months. The most frequent clinical manifestation of COVID-19 is pneumonia, which in about 20% of cases results in acute respiratory failure. Very few studies have so far addressed the problem of clinical and functional recovery in these patients, most of them just before or after discharge and none specifically focused on patients admitted for ARF. Indeed most of these investigations were limited to a specific field such as symptoms, pulmonary function and radiological changes. There are no guidelines for the follow-up of COVID-19 patients, despite the British Thoracic Society (BTS) has published a guidance for scheduling post-hospitalization assessments.
Aim of this study is to describe the long term (6 to 12 months) evolution of lung involvement in patients discharged after an episode of ARF due to COVID-19, identifying possible factor associated to lasting clinical, functional or radiological abnormalities collecting data from hospital stay, 1-month after hospital discharge, 3-months after hospital discharge and 6-to-12-months after hospital discharge.
Read the detailed description
Coronaviruses are a family of viruses with marked tropism for the respiratory system, being able to cause heterogeneous pathological states in humans ranging from the common cold to more serious diseases such as Respiratory Syndrome severe acute respiratory syndrome (SARS). In December 2019 in Wuhan in China, the first case of human infection by a new coronavirus was identified, currently called SARS-COV-2 (Severe Acute Respiratory Syndrome - Coronavirus - 2), characterized by high contagiousness and the possibility of causing a severe acute respiratory distress syndrome from which its acronym derives and which caused the state of a global pandemic in a few months. The disease caused by the SARS-COV-2 virus is called COVID 19.
The most frequent clinical manifestation of COVID-19 is pneumonia, which in about 20% of cases results in acute respiratory failure requiring oxygen therapy or ventilatory support. sometimes resulting in a picture similar to that caused by acute respiratory distress syndrome (ARDS), found in 60-70% of patients admitted to intensive care. The pathogenesis of classical ARDS involves three phases of the disease: an exudative, a proliferative and a fibrotic phase, which occurs when the removal of alveolar collagen fails and leads to progressive pulmonary fibrosis. It is not known whether the long-term evolution of the COVID 19 disease could result in the establishment of a fibrotic phase similar to that predicted by the pathogenesis of classical ARDS, which would lead to a chronic ventilatory deficit similar to that of pulmonary interstitial diseases, with serious impact on quality of life and mortality.
However, it is not well-known whether SARS-COV-2 pneumonia causes restitutio ad integrum or whether it can induce persistent parenchymal alterations and lung function abnormalities.
Very few studies have so far addressed the problem of clinical and functional recovery in these patients, most of them just before or after discharge and none specifically focused on patients admitted for ARF. Indeed most of these investigations were limited to a specific field such as symptoms, pulmonary function and radiological changes.There are no guidelines for the follow-up of COVID-19 patients, despite the British Thoracic Society (BTS) has published a guidance for scheduling post-hospitalization assessments.
Aim of this study, spontaneous,observational, both prospectic and retrospective, is to describe the long term (6 to 12 months) evolution of lung involvement in patients discharged after an episode of ARF due to COVID-19, identifying possible factor associated to lasting clinical, functional or radiological abnormalities.
Investigators will collect clinical, functional and radiological parameters during:
- the hospital stay due to COVID-19 (H);
- the 1-month after hospital discharge followup visit (V1);
- the 3-months after hospital discharge followup visit (V2);
- the 6-to-12-months after hospital discharge followup visit, performed for study subjects that at V2 show clinical and/or functional and/or radiological abnormalities due to sequelae of COVID-19 (V3).
For data analysis, all variables will be analyzed using descriptive method. Continuous variables will be presented as means, standard deviation, median and respective minimum and maximum values; the discrete or nominal variables will be expressed as frequencies and relative percentages. Subgroup analysis will be performed using X- 2 test or Fischer test when appropriate; parametric variables not normally distributed will be analyzed by Kruskal-wallis non-parametric test. Association between two or more parameters will be calculate with Spearman Correlation. p <0.05 values will be considered statistically significant.
This study was approved by the Local Ethic Committee.
- Conditions
- SARS-COV-2 Pneumonia
- Being tested
- Clinical, functional and radiological lung involvement evolution
- Keywords
- SARS-COV-2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical, functional and radiological lung involvement evolutionOther
Observational / Clinical, functional and radiological long term evolution of SARS-COV-2 lung involvement
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute respiratory failure due to SARS-COV-2 | Patients admitted to hospital with acute respiratory failure due to SARS-COV-2 infection causing pneumonia Receives: Other: Clinical, functional and radiological lung involvement evolution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term evolution of clinical involvement due to SARS-COV-2 pneumonia / symptoms
For long term clinical evolution of SARS-COV-2 pneumonia Investigators will evaluate the presence or absence of each of the following symptoms (yes/no respectively for presence/absence):
- dyspnea,
- fatigue,
- cough,
- fever,
- thoracic pain,
- nausea,
- diarrhea,
- dysgeusia. The presence of each of these symptoms will be collected at the time of the hospital stay due to COVID-19 (H) and at 1-month after hospital discharge followup visit (V1); at 3-months after hospital discharge followup visit (V2); at 6-to-12-months after hospital discharge followup visit (V3). V3 will be performed for study subjects that at V2 show clinical and/or functional and/or radiological abnormalities due to sequelae of COVID-19.
Differences in terms of presence and type of each symptoms between H, V1, V2 and V3 will be evaluated.
Measured: from hospital stay to 6-to-12 months after hospital discharge for SARS-COV-2 pneumonia.
Long term evolution of clinical involvement due to SARS-COV-2 pneumonia / respiratory rate
For long term clinical evolution of SARS-COV-2 pneumonia Investigators will collect respiratory rate (RR, breaths/minute) of study subjects collected during the hospital stay due to COVID-19 (H); at V1, V2and V3. Difference in RR between H, V1, V2 and V3 will be evaluated.
Measured: from hospital stay to 6-to-12 months after hospital discharge for SARS-COV-2 pneumonia.
Long term evolution of functional involvement due to SARS-COV-2 pneumonia - blood gas exchange parameters/partial pressure of oxygen and partial pressure of carbon monoxide
Investigators will collect:
- partial pressure of oxygen [paO2, mmHg],
- partial pressure of carbon monoxide [paCO2 mmHg], emerged from blood gas exchange analysis performed during H, V1, V2 and V3. For each parameter (paO2, paCO2) the difference between value at H, V1,V2 and V3 will be evaluated.
Measured: from hospital stay to 6-to-12 months after hospital discharge for SARS-COV-2 pneumonia
Long term evolution of functional involvement due to SARS-COV-2 pneumonia - blood gas exchange parameters/ ph
Investigators will collect:
- ph [absolute value], emerged from blood gas exchange analysis performed during H, V1, V2 and V3. Difference between pH value at H, V1,V2 and V3 will be evaluated.
Measured: from hospital stay to 6-to-12 months after hospital discharge for SARS-COV-2 pneumonia
Long term evolution of functional involvement due to SARS-COV-2 pneumonia - blood gas exchange parameters/ oxygen saturation
Investigators will collect:
- oxygen saturation [SatO2, in %]), emerged from blood gas exchange analysis performed during H, V1, V2 and V3. Difference between SatO2 value at H, V1,V2 and V3 will be evaluated.
Measured: from hospital stay to 6-to-12 months after hospital discharge for SARS-COV-2 pneumonia
Long term evolution of functional involvement due to SARS-COV-2 pneumonia - blood gas exchange parameters: P/F ratio
Investigators will collect:
- P/F ratio (ratio between the measured paO2 and fraction of inspired oxygen ratio) expressed in absolute ratio; emerged from blood gas exchange analysis performed during H, V1, V2 and V3. Difference between P/F ratio value at H, V1,V2 and V3 will be evaluated.
Measured: from hospital stay to 6-to-12 months after hospital discharge for SARS-COV-2 pneumonia
Long term evolution of functional involvement due to SARS-COV-2 pneumonia - pulmonary function tests/ forced expiratory volume in the first second; forced vital capacity; total lung capacity; residual volume
Investigators will consider the following parameters:
- forced expiratory volume in the first second [FEV1,expressed in % of predicted value];
- forced vital capacity [FVC, expressed in % of predicted value];
- total lung capacity [TLC, expressed in % of predicted value];
- residual volume [RV, expressed in % of predicted value]; collected through pulmonary function tests performed at V1, V2 and V3. For each parameter (FEV1, FVC, TLC, RV) the difference between value at V1,V2 and V3 will be evaluated.
Measured: from 1 month after hospital discharge for SARS-COV-2 pneumonia to 6-to-12 months after hospital discharge
Long term evolution of functional involvement due to SARS-COV-2 pneumonia - pulmonary function tests/ FEV1/FVC ratio and RV/TLC ratio
Investigators will consider the following parameters:
- FEV1/FVC absolute ratio;
- RV/TLC absolute ratio; collected through pulmonary function tests performed at V1, V2 and V3. For each parameter (FEV1/FVC, RV/TLC) the difference between value at V1,V2 and V3 will be evaluated.
Measured: from 1 month after hospital discharge for SARS-COV-2 pneumonia to 6-to-12 months after hospital discharge
Long term evolution of functional involvement due to SARS-COV-2 pneumonia - diffusing capacity of carbon monoxide
Investigators will consider diffusing capacity of carbon monoxide (DLCO), expressed in % of the predicted value collected during V1, V2 and V3. Differences in terms of DLCO values between V1, V2 and V3 will be calculated.
Measured: from 1 month after hospital discharge for SARS-COV-2 pneumonia to 6-to-12 months after hospital discharge
Long term evolution of functional involvement due to SARS-COV-2 pneumonia - six minute walking test distance
Investigators will consider 6 minute walking test [6MWT] distance, expressed in meters collected during V1, V2 and V3. Differences in terms of 6MWT distance between V1, V2 and V3 will be calculated.
Measured: from 1 month after hospital discharge for SARS-COV-2 pneumonia to 6-to-12 months after hospital discharge.
Long term evolution of functional involvement due to SARS-COV-2 pneumonia - presence of desaturation during six minute walking test
Investigators will consider the presence (yes/no) of desaturation at 6MWT (defined as a difference > 3% between baseline SatO2% and minimum SatO2% during test) collected during V1, V2 and V3. Differences in terms of presence of desaturation at 6MWT between V1, V2 and V3 will be calculated.
Measured: from 1 month after hospital discharge for SARS-COV-2 pneumonia to 6-to-12 months after hospital discharge.
long term evolution of radiological involvement due to SARS-COV-2 pneumonia
For long term radiological evolution of SARS-COV-2 pneumonia Investigators will consider:
- presence [yes/no] of consolidation and/or ground-glass opacities at chest X-ray and high resolution computed tomography (HRCT) of the lungs,
- presence/absence [yes/no] of lung abnormalities in lung ultrasound (LUS) evaluation, collected each during H, V1, V2 and V3. Differences between H,V1,V2 and V3 for each characteristics will be described.
Measured: from hospital stay to 6-to-12 months after hospital discharge for SARS-COV-2 pneumonia.
Secondary outcomes (1)
identifying possible factors associated to the persistency of clinical, functional and radiological long term lung involvement due to COVID-19
To identify possible factors associated or correlated to the persistency of clinical and/or functional and/or radiological long term lung involvement due to SARS-COV-2 pneumonia at V1, V2, V3, primary outcome measurements will be stratified according to:
- the presence [yes/no] of comorbidities (cardiovascular, chronic obstructive pulmonary disease, asthma, immunological disorders, solid cancer, hematological malignancy, diabetes mellitus, immunodepression);
- age (expressed in years, age≥60 versus age<60 years);
- sex (male versus female);
- hospital stay duration (expressed in days);
- acute respiratory failure duration (expressed in days); of study subjects.
Measured: from hospital stay to 6-to-12 months after hospital discharge for SARS-COV-2 pneumonia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start30 Jul 2020
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-COV-2 PneumoniaStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Stefano Nava, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605757
- Sponsor's protocol ID
- 714/2020/Oss/AOUBo
- Status last verified
- Jan 2021
- First submitted
- 11 Oct 2020
- Last updated
- 12 Jan 2021
- 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 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Involvement of Novel SARS-COV-2 Infection (COVID-19): Long-term Impact and Predictors of Possible Lasting Damage: Follow the Covid Study
- ClinicalTrials.gov ID
- NCT04605757
- Acronym / sponsor ID
- 714/2020/Oss/AOUBo
- Conditions
- SARS-COV-2 Pneumonia
- Keywords
- SARS-COV-2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 28 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.
In December 2019 the first case of human infection by a new coronavirus was identified, currently called SARS-COV-2 (Severe Acute Respiratory Syndrome - Coronavirus - 2), characterized by high contagiousness and the possibility of causing a severe acute respiratory distress syndrome from which its acronym derives and which caused the state of a global pandemic in a few months. The most frequent clinical manifestation of COVID-19 is pneumonia, which in about 20% of cases results in acute respiratory failure. Very few studies have so far addressed the problem of clinical and functional recovery in these patients, most of them just before or after discharge and none specifically focused on patients admitted for ARF. Indeed most of these investigations were limited to a specific field such as symptoms, pulmonary function and radiological changes. There are no guidelines for the follow-up of COVID-19 patients, despite the British Thoracic Society (BTS) has published a guidance for scheduling post-hospitalization assessments.
Aim of this study is to describe the long term (6 to 12 months) evolution of lung involvement in patients discharged after an episode of ARF due to COVID-19, identifying possible factor associated to lasting clinical, functional or radiological abnormalities collecting data from hospital stay, 1-month after hospital discharge, 3-months after hospital discharge and 6-to-12-months after hospital discharge.
Detailed description
Coronaviruses are a family of viruses with marked tropism for the respiratory system, being able to cause heterogeneous pathological states in humans ranging from the common cold to more serious diseases such as Respiratory Syndrome severe acute respiratory syndrome (SARS). In December 2019 in Wuhan in China, the first case of human infection by a new coronavirus was identified, currently called SARS-COV-2 (Severe Acute Respiratory Syndrome - Coronavirus - 2), characterized by high contagiousness and the possibility of causing a severe acute respiratory distress syndrome from which its acronym derives and which caused the state of a global pandemic in a few months. The disease caused by the SARS-COV-2 virus is called COVID 19.
The most frequent clinical manifestation of COVID-19 is pneumonia, which in about 20% of cases results in acute respiratory failure requiring oxygen therapy or ventilatory support. sometimes resulting in a picture similar to that caused by acute respiratory distress syndrome (ARDS), found in 60-70% of patients admitted to intensive care. The pathogenesis of classical ARDS involves three phases of the disease: an exudative, a proliferative and a fibrotic phase, which occurs when the removal of alveolar collagen fails and leads to progressive pulmonary fibrosis. It is not known whether the long-term evolution of the COVID 19 disease could result in the establishment of a fibrotic phase similar to that predicted by the pathogenesis of classical ARDS, which would lead to a chronic ventilatory deficit similar to that of pulmonary interstitial diseases, with serious impact on quality of life and mortality.
However, it is not well-known whether SARS-COV-2 pneumonia causes restitutio ad integrum or whether it can induce persistent parenchymal alterations and lung function abnormalities.
Very few studies have so far addressed the problem of clinical and functional recovery in these patients, most of them just before or after discharge and none specifically focused on patients admitted for ARF. Indeed most of these investigations were limited to a specific field such as symptoms, pulmonary function and radiological changes.There are no guidelines for the follow-up of COVID-19 patients, despite the British Thoracic Society (BTS) has published a guidance for scheduling post-hospitalization assessments.
Aim of this study, spontaneous,observational, both prospectic and retrospective, is to describe the long term (6 to 12 months) evolution of lung involvement in patients discharged after an episode of ARF due to COVID-19, identifying possible factor associated to lasting clinical, functional or radiological abnormalities.
Investigators will collect clinical, functional and radiological parameters during:
- the hospital stay due to COVID-19 (H);
- the 1-month after hospital discharge followup visit (V1);
- the 3-months after hospital discharge followup visit (V2);
- the 6-to-12-months after hospital discharge followup visit, performed for study subjects that at V2 show clinical and/or functional and/or radiological abnormalities due to sequelae of COVID-19 (V3).
For data analysis, all variables will be analyzed using descriptive method. Continuous variables will be presented as means, standard deviation, median and respective minimum and maximum values; the discrete or nominal variables will be expressed as frequencies and relative percentages. Subgroup analysis will be performed using X- 2 test or Fischer test when appropriate; parametric variables not normally distributed will be analyzed by Kruskal-wallis non-parametric test. Association between two or more parameters will be calculate with Spearman Correlation. p <0.05 values will be considered statistically significant.
This study was approved by the Local Ethic Committee.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute respiratory failure due to SARS-COV-2 | – | Other: Clinical, functional and radiological lung involvement evolutionPatients admitted to hospital with acute respiratory failure due to SARS-COV-2 infection causing pneumonia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients with SARS-COV-2 pneumonia discharged from our Insitution (Respiratory and Critical Care Unit - S.Orsola-Malpighi University Hospital, Bologna, IT) or patients referred to our Clinic for the followup of SARS-COV-2 pneumonia after hospital stay.
Key inclusion criteria (2 listed)
- acute respiratory failure due to SARS-COV-2 pneumonia
- sign of informed consent
Key exclusion criteria (1 listed)
- none
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, functional and radiological lung involvement evolutionObservational / Clinical, functional and radiological long term evolution of SARS-COV-2 lung involvement | Other | Patients with acute respiratory failure due to SARS-COV-2 |
Primary outcome
Long term evolution of clinical involvement due to SARS-COV-2 pneumonia / symptoms
Time frame: from hospital stay to 6-to-12 months after hospital discharge for SARS-COV-2 pneumonia.
For long term clinical evolution of SARS-COV-2 pneumonia Investigators will evaluate the presence or absence of each of the following symptoms (yes/no respectively for presence/absence): * dyspnea, * fatigue, * cough, * fever, * thoracic pain, * nausea, * diarrhea, * dysgeusia. The presence of each of these symptoms will be collected at the time of the hospital stay due to COVID-19 (H) and at 1-month after hospital discharge followup visit (V1); at 3-months after hospital discharge followup visit (V2); at 6-to-12-months after hospital discharge followup visit (V3). V3 will be performed for study subjects that at V2 show clinical and/or functional and/or radiological abnormalities due to sequelae of COVID-19. Differences in terms of presence and type of each symptoms between H, V1, V2 and V3 will be evaluated.
Long term evolution of clinical involvement due to SARS-COV-2 pneumonia / respiratory rate
Time frame: from hospital stay to 6-to-12 months after hospital discharge for SARS-COV-2 pneumonia.
For long term clinical evolution of SARS-COV-2 pneumonia Investigators will collect respiratory rate (RR, breaths/minute) of study subjects collected during the hospital stay due to COVID-19 (H); at V1, V2and V3. Difference in RR between H, V1, V2 and V3 will be evaluated.
Long term evolution of functional involvement due to SARS-COV-2 pneumonia - blood gas exchange parameters/partial pressure of oxygen and partial pressure of carbon monoxide
Time frame: from hospital stay to 6-to-12 months after hospital discharge for SARS-COV-2 pneumonia
Investigators will collect: * partial pressure of oxygen [paO2, mmHg], * partial pressure of carbon monoxide [paCO2 mmHg], emerged from blood gas exchange analysis performed during H, V1, V2 and V3. For each parameter (paO2, paCO2) the difference between value at H, V1,V2 and V3 will be evaluated.
Long term evolution of functional involvement due to SARS-COV-2 pneumonia - blood gas exchange parameters/ ph
Time frame: from hospital stay to 6-to-12 months after hospital discharge for SARS-COV-2 pneumonia
Investigators will collect: - ph [absolute value], emerged from blood gas exchange analysis performed during H, V1, V2 and V3. Difference between pH value at H, V1,V2 and V3 will be evaluated.
Long term evolution of functional involvement due to SARS-COV-2 pneumonia - blood gas exchange parameters/ oxygen saturation
Time frame: from hospital stay to 6-to-12 months after hospital discharge for SARS-COV-2 pneumonia
Investigators will collect: - oxygen saturation [SatO2, in %]), emerged from blood gas exchange analysis performed during H, V1, V2 and V3. Difference between SatO2 value at H, V1,V2 and V3 will be evaluated.
Long term evolution of functional involvement due to SARS-COV-2 pneumonia - blood gas exchange parameters: P/F ratio
Time frame: from hospital stay to 6-to-12 months after hospital discharge for SARS-COV-2 pneumonia
Investigators will collect: - P/F ratio (ratio between the measured paO2 and fraction of inspired oxygen ratio) expressed in absolute ratio; emerged from blood gas exchange analysis performed during H, V1, V2 and V3. Difference between P/F ratio value at H, V1,V2 and V3 will be evaluated.
Long term evolution of functional involvement due to SARS-COV-2 pneumonia - pulmonary function tests/ forced expiratory volume in the first second; forced vital capacity; total lung capacity; residual volume
Time frame: from 1 month after hospital discharge for SARS-COV-2 pneumonia to 6-to-12 months after hospital discharge
Investigators will consider the following parameters: * forced expiratory volume in the first second [FEV1,expressed in % of predicted value]; * forced vital capacity [FVC, expressed in % of predicted value]; * total lung capacity [TLC, expressed in % of predicted value]; * residual volume [RV, expressed in % of predicted value]; collected through pulmonary function tests performed at V1, V2 and V3. For each parameter (FEV1, FVC, TLC, RV) the difference between value at V1,V2 and V3 will be evaluated.
Long term evolution of functional involvement due to SARS-COV-2 pneumonia - pulmonary function tests/ FEV1/FVC ratio and RV/TLC ratio
Time frame: from 1 month after hospital discharge for SARS-COV-2 pneumonia to 6-to-12 months after hospital discharge
Investigators will consider the following parameters: * FEV1/FVC absolute ratio; * RV/TLC absolute ratio; collected through pulmonary function tests performed at V1, V2 and V3. For each parameter (FEV1/FVC, RV/TLC) the difference between value at V1,V2 and V3 will be evaluated.
Long term evolution of functional involvement due to SARS-COV-2 pneumonia - diffusing capacity of carbon monoxide
Time frame: from 1 month after hospital discharge for SARS-COV-2 pneumonia to 6-to-12 months after hospital discharge
Investigators will consider diffusing capacity of carbon monoxide (DLCO), expressed in % of the predicted value collected during V1, V2 and V3. Differences in terms of DLCO values between V1, V2 and V3 will be calculated.
Long term evolution of functional involvement due to SARS-COV-2 pneumonia - six minute walking test distance
Time frame: from 1 month after hospital discharge for SARS-COV-2 pneumonia to 6-to-12 months after hospital discharge.
Investigators will consider 6 minute walking test [6MWT] distance, expressed in meters collected during V1, V2 and V3. Differences in terms of 6MWT distance between V1, V2 and V3 will be calculated.
Long term evolution of functional involvement due to SARS-COV-2 pneumonia - presence of desaturation during six minute walking test
Time frame: from 1 month after hospital discharge for SARS-COV-2 pneumonia to 6-to-12 months after hospital discharge.
Investigators will consider the presence (yes/no) of desaturation at 6MWT (defined as a difference > 3% between baseline SatO2% and minimum SatO2% during test) collected during V1, V2 and V3. Differences in terms of presence of desaturation at 6MWT between V1, V2 and V3 will be calculated.
long term evolution of radiological involvement due to SARS-COV-2 pneumonia
Time frame: from hospital stay to 6-to-12 months after hospital discharge for SARS-COV-2 pneumonia.
For long term radiological evolution of SARS-COV-2 pneumonia Investigators will consider: * presence [yes/no] of consolidation and/or ground-glass opacities at chest X-ray and high resolution computed tomography (HRCT) of the lungs, * presence/absence [yes/no] of lung abnormalities in lung ultrasound (LUS) evaluation, collected each during H, V1, V2 and V3. Differences between H,V1,V2 and V3 for each characteristics will be described.
1 secondary outcome
identifying possible factors associated to the persistency of clinical, functional and radiological long term lung involvement due to COVID-19
Time frame: from hospital stay to 6-to-12 months after hospital discharge for SARS-COV-2 pneumonia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- 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.
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 SARS-COV-2 Pneumonia, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 2 inclusion and 1 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 12 Jan 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irene Prediletto, MD-PhD (+390512143253, irene.prediletto@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term evolution of clinical involvement due to SARS-COV-2 pneumonia / symptoms (time frame: from hospital stay to 6-to-12 months after hospital discharge for SARS-COV-2 pneumonia.). The study lists 12 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 12 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.