OUTPATIENT TREATMENT OF COVID-19 WITH EARLY PULMONARY CORTICOSTEROIDS AS AN OPPORTUNITY TO MODIFY THE COURSE OF THE DISEASE

Phase 1

• Conditions: COVID-19; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001622-64-ES
• Lead Sponsor: Dra Ana Pueyo Bastida

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-20
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

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

Inclusion Criteria

- Age 18 to 75.
- Both sexes
- Diagnosis of SARS-CoV-2 infection, by PCR and/or Ac (IgM+) and/or Ag test - Clinical diagnosis of pulmonary involvement (respiratory symptoms +/- pathological auscultation +/- O2 desaturation) + Chest X with mild-moderate or normal alterations. - Verbal informed consent in front of witnesses, reflected in medical records.
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

- Desaturation <93% or PO2 < 62
- Moderate-severe dyspnea or significant respiratory or general deterioration that makes admission advisable.
- Chest x-ray with multifocal cotton infiltrates.
- Insulin-dependent diabetes with poor control or glycaemia in the emergency analysis greater than 300 mg/ml (fasting or not).
- Other significant comorbidities: severe renal failure CrCl < 30 ml/min; cirrhosis or chronic liver disease, poorly controlled hypertension.
- Heart rhythm disturbances (including prolonged QT).
- Severe immunosuppression (HIV infection, long-term use of immunosuppressive agents); cancer.
- Pregnant or lactating women
- Use of glucocorticoids for other diseases
- Unwilling or unable to participate until the study is complete - Participate in another study
- Allergy or intolerance to any of the study drugs (Prednisone, Azithromycin or Hydroxychloroquine)
- Taking any of the drugs being tested within 7 days of being included in the study - Non-suppressible drugs with risk of QT prolongation or significant interactions.

Study & Design

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