Clinical Features of COVID-19 Patients

Covid19 Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04815304
• Other study ID #: 26100/21
• Status: Completed
• Start date: March 13, 2020
• Est. completion date: November 13, 2023

Study information

• Verified date: November 2023
• Source: San Salvatore Hospital of L'Aquila
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 13, 2023
• Est. primary completion date: October 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• COVID-19
• Covid19
• Hypoventilation
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome
• Ventilatory Failure

Intervention

Diagnostic Test:
• peripheral lymphocytes subsets
The data were collected during the first and the second wave of epidemic in COVID-19 patients with acute respiratory distress syndrome. At the moment of hospitalization, 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 (lung ultrasound score, diaphragmatic thickness and motion), arterial blood gas analysis 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. Macroscopic and microscopic hypopharynx and larynx damages were also evaluated by video-laryngoscopy and light miscoscopy.

Locations

Country	Name	City	State
Italy	San Salvatore Academic Hospital	L'Aquila

Sponsors (1)

Lead Sponsor	Collaborator
San Salvatore Hospital of L'Aquila

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral lymphocyte subsets	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	Chest computed tomography	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
Secondary	Chest ultrasonography	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
Secondary	Pain assessment	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
Secondary	Upper airway damages	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