SE OF CORTICOSTEROIDS IN PATIENTS WITH SARS-COV2 CORONAVIRUS INFECTIO

Phase 1

• Conditions: SARS-CoV-2 infection (COVID-19); MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001934-37-ES
• Lead Sponsor: IDIVAL Instituto de Investigación Sanitaria Valdecilla

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-08
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

- Patients admitted to hospital with Covid-19, confirmed by microbiological tests or compatible clinical manifestations, with exclusion of other infections.
- Age: 18-85 years old.
- Time of evolution: more than 7 days since the beginning of symptoms.
- Evidence of inflammation, defined by: Lung infiltrates + Gas exchange disturbance: PaO2 < 65 or Sat<93% (breathing air), or PAFI <300, or SAFI <440, or BCRSS =2 + Elevated biomarkers: PCR >15, or DD>800, or Ferritin >1000, or IL6>20
- Absence of bacterial infection or other disease that explains the lung disorder.
- Verbal informed consent, which will be recorded in history.
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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

- Refusal to participate
- Pregnancy
- Established indication for mechanical ventilation, non-invasive ventilation or ICU admission
- Immunosuppression
- Chronic renal failure on dialysis

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of early anti-inflammatory treatment with corticosteroids in patients who are in a phase of the disease in which viral replication has already been limited, but there is a marked systemic inflammatory response.;Secondary Objective: To evaluate the safety of early anti-inflammatory treatment with corticosteroids;Primary end point(s): Combination of death, ICU stay or non-invasive ventilation (NIV).;Timepoint(s) of evaluation of this end point: At the time of discharge or death

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Individual components of the primary variable.<br>- Clinical-gasometric impairment after the test intervention (defined as: (a) PaO2/FIO2<250; or (b) shock); or (c) worsening of qSOFA or BCRSS indices).<br>- Change in SOFA score (comparison at time of inclusion and at 4 days).<br>- Length of hospital stay.<br>- Use of biological anti-inflammatories.;Timepoint(s) of evaluation of this end point: At the time of discharge or death