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

Dra Ana Pueyo Bastida0 个研究点目标入组 200 人开始时间: 2020年4月20日最近更新: 2020年9月28日

适应症

试验速览

暂无简介。

•- 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

•- 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.

发起方

Dra Ana Pueyo Bastida