Efficacy of the early use of corticotherapy in CoV-2 infection to prevent the progression of acute respiratory distress syndrome (ARDS)

Phase 1

• Conditions: MedDRA version: 23.0Level: PTClassification code 10084380Term: COVID-19 pneumoniaSystem Organ Class: 10021881 - Infections and infestations; COVID-19 Pneunomia (SARS-CoV-2); Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002186-34-ES
• Lead Sponsor: Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR).

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-22
• Last Update Posted: 13 September 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Age 18 - 80
2. Coronavirus-19 infection (SARS-CoV-2) demonstrated by nasopharyngeal smears PCR or any other biological sample
3. COVID-19 described as:
- Nasopharyngeal smear with SARS-CoV-2 positive PCR
- Lung infiltrates by radiography (or other imaging technique) consistent with pneumonia
- Puntuation of 3 or 4 in the WHO Ordinal Scale for Clinical Improvement for COVID-19
- One of the following criteria:
a) Ambient air oxygen saturation> 90 and <94%
b) Pa: FiO2 (partial pressure O2 / fraction of inspired O2)> 200 and =300 mmHg
c) Sa: FiO2 (O2 saturation measured with
pulse oximeter / inspired O2 fraction) =350
- All patients will receive standard treatment according to site guidelines (eg hydroxychloroquine), as long as there is no contraindication for it.
5. Informed consent (according to protocol instructions)
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1.Previous treatment with oral or intravenous corticosteroids for more than 5 days in a row or alternate days (6 previous months)
2.Treatment during the previous 12 months with biological drugs such as monoclonal antibodies including anti-TNFa, anti-interleukins, Interferons type I.
3.Any other contraindication for the use of individualized corticosteroid pulses according to the clinical criteria of the patient medical team.
4.Contraindications to treatment with methylprednisolone (limited to known hypersensitivity to the active substance and its excipients), as well as receiving treatment in a post-vaccination period (with live or live attenuated microorganism vaccines).
5.Patients with severe SDRA, defined as SaFi < 150.
6.Patients with chronic obstructive pulmonary disease requiring home oxygen.

Study & Design

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