EARLY TREATMENT OF PNEUMONIA COVID-19 WITH GLUCOCORTICOIDS.RANDOMIZED CONTROLLED CLINICAL TRIA

Phase 1

• Conditions: CoVid-19 pneumonia in early inflammatory phase (stage II).; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001827-15-ES
• Lead Sponsor: AVARRABIOMED - FUNDACIÓN MIGUEL SERVET

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

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

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Age =18 years.
• Diagnosis of SARS-CoV-2 pneumonia by reverse transcriptase polymerase chain reaction (RT-PCR) in nasopharyngeal or sputum smears according to the recommendations of the Ministry of Health.
• Duration of symptoms = 7 days.
• At least one of the following: C-reactive protein (PCR)> 60 mg / L or interleukin 6 (IL-6)> 40 pg / mL or ferritin> 1000 µg / L.
• Acceptance of 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 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54

Exclusion Criteria

• Allergy or contraindication to the drugs under study.
• Respiratory failure data: SpO2 <90% (in ambient air) or PaO2 <60 mmHg (in ambient air) or PaO2 / FiO2 <300 mmHg.
• Need for glucocorticoids or immunosuppressants (including biological ones) with another indication.
• Decompensated diabetes mellitus.
• Uncontrolled hypertension.
• Psychotic or manic disorder.
• Active cancer.
• Pregnancy or lactation.
• Clinical or biochemical suspicion (procalcitonin> 0.5 ng / mL) of active infection other than SARS-CoV-2.
• Out-of-hospital management patient.
• Conservative or palliative management patient.
• Participation in another clinical trial.
• Any important and uncontrolled medical, psychological, psychiatric, geographic or social problem that contraindicates the patient's participation in the trial or that does not allow adequate follow-up and adherence to the protocol and evaluation of the study results.

Study & Design

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