treatment with inhaled corticoids in patients with covid-19 and pneumonia

Phase 1

• Conditions: COVID19; Therapeutic area: Diseases [C] - Virus Diseases [C02]; MedDRA version: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 100000004862

• Registration Number: EUCTR2020-001616-18-ES
• Lead Sponsor: Fundació Clinic per a la Recerca Biomèdica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-20
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1.COVID19
2.Age >18 and <80
3.Admitted for pneumonia (status #3 and #4 OMS scale)
4.Informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1.Pregnancy
2.Contraindications for inhaled corticoids therapy
3.Participating in another intervention trial on COVID19
4. Current treatment with inhaled or systemic corticosteroids

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Check whether adding Inhaled corticoids (budesonide) reduces or not the risk of ARDS and improves prognosis in COVID19 patients admitted with pneumonia;Secondary Objective: •Assess the effect of IC in the duration of hospital stay<br>•Complications during admittance<br>•Circulating levels of systemic inflammation markers<br>•Mortality at 30 and 90 days after hospital discharge;Primary end point(s): proportion of subjects with therapeutic failure.<br>Is a composite outcome: patients requiring mechanical ventilation, high flow oxygenotherapy, receiving systemic corticoids and/or anti IL1 , anti IL-6 and/or dying for any cause;Timepoint(s) of evaluation of this end point: Day 15 after initiating treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1- Clinical evolution (discharge, ARDS, death, ICU refusal)<br>2- Temperature heart rate, blood pressure, PaO2/FiO2 <br>3-Systemic biomarkers <br>4- Duration of hospital stay<br>5- Complications during admittance (infectious, CV, metabolic, others)<br>6- Mortality for any cause<br>7- vital status<br>8- changes in clinical status (OMS 7 point scale);Timepoint(s) of evaluation of this end point: 1- admission, day 3, day 7 and discharge<br>2- admission, day 3, day 7 and discharge<br>3-admission, day 3, day 7 and discharge<br>4- at discharge<br>5- at discharge<br>6- at exitus<br>7- at exitus, day +30 and day +90 (if applicable)<br>8- day 3, day 7, day 15 and discharge