Clinical Features of COVID-19 Patients

Sponsor
San Salvatore Hospital of L'Aquila (Other)
Overall Status
Recruiting
CT.gov ID
NCT04815304
Collaborator
(none)
200
1
27
7.4

Study Details

Study Description

Brief Summary

The data were retrospectively collected during the first and the second wave of epidemic in COVID-19 patients with Severe Acute Respiratory Syndrome Coronavirus 2, at the moment of intensive care unit admission and during the in intensive care unit staying.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: peripheral lymphocytes subsets

Detailed Description

At the moment of intensive care unit admission and during the in intensive care unit staying, the following data were collected: peripheral lymphocyte subsets were measured by multiple-color flow cytometry, chest computed tomography and ultrasonography scans, arterial blood gas parameters (pH, partial pressure of carbon dioxide, partial pressure of oxygen, concentration of hydrogen carbonate, base excess, and arterial oxygen saturation), and pain assessed by using numeric rating scale.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Clinical Features of Severe Acute Respiratory Syndrome Coronavirus 2 Patients Admitted to the Intensive Care Units of Academic Hospital of L'Aquila (Italy)
Actual Study Start Date :
Mar 13, 2020
Anticipated Primary Completion Date :
May 28, 2022
Anticipated Study Completion Date :
Jun 13, 2022

Outcome Measures

Primary Outcome Measures

  1. Peripheral lymphocyte subsets [Change from date of hospitalization until the date of hospital discharge or date of death from any cause, whichever came first, assessed at 60 weeks]

    Peripheral lymphocyte subsets were measured by multiple-color flow cytometry,

Secondary Outcome Measures

  1. Chest computed tomography [From date of hospitalization until the date of hospital discharge or date of death from any cause, whichever came first, assessed every 10 days up to 60 weeks]

    A chest computed tomography performed to assess lung damage

  2. Chest ultrasonography [From date of hospitalization until the date of hospital discharge or date of death from any cause, whichever came first, assessed every day up to 60 weeks]

    Lung ultrasound score (sum of points in all 12 regions and ranges from 0 to 36; 0 points-presence of lung sliding with A lines or one or two isolated B lines; 1 point-moderate loss of lung aeration with three or four B lines (septal rockets); 2 points-severe loss of lung aeration with five or more B lines (glass rockets); and 3 points-presence of a hypoechoic poorly defined tissue characterized by consolidation)

  3. Pain assessment [From date of hospitalization until the date of hospital discharge or date of death from any cause, whichever came first, assessed every day up to 60 weeks]

    Pain assessed by using numeric rating scale (the 11-point numeric scale ranges from '0' representing one pain extreme [e.g. "no pain"] to '10' representing the other pain extreme [e.g. "pain as bad as you can imagine" or "worst pain imaginable])

  4. Upper airway damages [From date of hospitalization until the date of hospital discharge or date of death from any cause, whichever came first, assessed every day up to 60 weeks]

    Macroscopic and microscopic hypopharynx and larynx damages evaluated by video-laryngoscopy and light microscopy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • COVID-19 patients

  • Acute respiratory distress syndrome

  • needing of ventilatory support

Exclusion Criteria:
  • asymptomatic COVID-19 patients

  • few symptoms

  • mild symptoms

  • without needing of ventilatory support

Contacts and Locations

Locations

Site City State Country Postal Code
1 San Salvatore Academic Hospital L'Aquila Italy 67100

Sponsors and Collaborators

  • San Salvatore Hospital of L'Aquila

Investigators

  • Study Chair: Franco Marinangeli, MD, ASL 1 - Avezzano Sulmona L'Aquila

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emiliano Petrucci, Medical Doctor, San Salvatore Hospital of L'Aquila
ClinicalTrials.gov Identifier:
NCT04815304
Other Study ID Numbers:
  • 26100/21
First Posted:
Mar 25, 2021
Last Update Posted:
Aug 18, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2021