Clinical Features of COVID-19 Patients

NCT04815304 | Completed DMC

• 1 other identifier: 26100/21
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Acute Respiratory Distress Syndrome; Ventilatory Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

• 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

• 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

Interventions

peripheral lymphocytes subsets DIAGNOSTIC_TEST

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.

Also known as: Chest computed tomography, Chest ultrasonography scan, arterial blood gas analysis, pain

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• COVID-19 patients
• Acute respiratory distress syndrome
• needing of ventilatory support

You may not qualify if:

• asymptomatic COVID-19 patients
• few symptoms
• mild symptoms
• without needing of ventilatory support

Sponsors & Collaborators

• San Salvatore Hospital of L'Aquila: lead

Study Sites (1)

San Salvatore Academic Hospital

L’Aquila, 67100, Italy

Location

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome; Hypoventilation

Interventions

Blood Gas Analysis; Pain Measurement

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques; Neurologic Examination; Physical Examination

Study Officials

• Franco Marinangeli, MD

  ASL 1 Avezzano Sulmona L'Aquila

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 25, 2021
• Study Start: March 13, 2020
• Primary Completion: October 28, 2023
• Study Completion: November 13, 2023
• Last Updated: November 27, 2023

Record last verified: 2023-11

Locations

IT (1)