Long-term Evolution of Pulmonary Involvement of Novel SARS-COV-2 Infection (COVID-19): Follow the Covid Study

NCT04605757 | Unknown

• 1 other identifier: 714/2020/Oss/AOUBo
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

SARS-COV-2 Pneumonia

Keywords

SARS-COV-2

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  from hospital stay to 6-to-12 months after hospital discharge for SARS-COV-2 pneumonia.

Study Arms (1)

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

Other: Clinical, functional and radiological lung involvement evolution

Interventions

Clinical, functional and radiological lung involvement evolution OTHER

Observational / Clinical, functional and radiological long term evolution of SARS-COV-2 lung involvement

Patients with acute respiratory failure due to SARS-COV-2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• acute respiratory failure due to SARS-COV-2 pneumonia
• sign of informed consent

You may not qualify if:

• none

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Respiratory and Critical Care Unit - S.Orsola-Malpighi University Hospital

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Interventions

Functional Status

Intervention Hierarchy (Ancestors)

Activities of Daily Living; Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

Irene Prediletto, MD-PhD

CONTACT

+390512143253; irene.prediletto@aosp.bo.it

Stefano Nava, MD

CONTACT

+390512143253; stefano.nava@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stefano Nava, Professor of Respiratory Medicine/ Alma Mater Studiorum University of Bologna (IT)- Director of Respiratory and Critical Care Unit/ S.Orsola-Malpighi University Hospital, Bologna (IT)

Study Record Dates

• First Submitted: October 11, 2020
• First Posted: October 28, 2020
• Study Start: July 30, 2020
• Primary Completion: April 30, 2021
• Study Completion: July 30, 2021
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)