Clinical Features of COVID-19 Patients

November 23, 2023 updated by: Emiliano Petrucci, San Salvatore Hospital of L'Aquila

Clinical Features of Severe Acute Respiratory Syndrome Coronavirus 2 Patients Admitted to the Intensive Care Units of Academic Hospital of L'Aquila (Italy)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • L'Aquila, Italy, 67100
        • San Salvatore Academic Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The data were collected during the first and the second wave of epidemic in COVID-19 patients with acute respiratory distress syndrome

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral lymphocyte subsets
Time Frame: 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,
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chest computed tomography
Time Frame: 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
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
Chest ultrasonography
Time Frame: 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)
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 assessment
Time Frame: 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])
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
Upper airway damages
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Salvatore Hospital of L'Aquila

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2020

Primary Completion (Actual)

October 28, 2023

Study Completion (Actual)

November 13, 2023

Study Registration Dates

First Submitted

March 19, 2021

First Submitted That Met QC Criteria

March 23, 2021

First Posted (Actual)

March 25, 2021

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26100/21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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