Clinical Features of COVID-19 Patients

Completed

• Conditions: Ventilatory Failure; Acute Respiratory Distress Syndrome; Covid19

• Registration Number: NCT04815304
• Lead Sponsor: San Salvatore Hospital of L'Aquila

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.

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 Timeline

• Study Start: 2020-03-13
• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-23
• Study First Posted: 2021-03-25
• Primary Completion: 2023-10-28
• Status Verified: 2023-11
• Study Completion: 2023-11-13
• Last Update Submitted: 2023-11-23
• Last Update Posted: 2023-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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 \[e.g. "pain as bad as you can imagine" or "worst pain imaginable\])
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)

Trial Locations

Locations (1)

San Salvatore Academic Hospital; 🇮🇹 L'Aquila, Italy