COVID-19
Conditions
Interventions
Trade Name: Dacortin
Pharmaceutical Form: Capsule
INN or Proposed INN: Prednisone
CAS Number: NA
Current Sponsor code: NA
Other descriptive name: PREDNISONE
Sponsors
Dra Ana Pueyo Bastida
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to explore the effectiveness and safety of oral corticosteroids (prednisone) in the treatment of early stage SARS-Cov-2 pneumonia in patients who do not yet meet hospital admission criteria.;Secondary Objective: Not applicable;Primary end point(s): referral from a Primary Care health professional, will be evaluated when they present symptoms of low respiratory tract, persistent cough, dyspnea, tightness in the chest, or for reappearance of fever, worsening or lack of improvement, after several days of previous clinic (general malaise, fever, upper tract symptoms, diarrhoea...). In the Emergency Department, the established triage and action procedure will be performed, which includes confirmation of the infection by PCR or determination of Ag (as established by the health authorities). Patients with a confirmed diagnosis of infection in previous days, and who have not received other treatment that is not symptomatic, will also be included. Variables to be determined include: auscultation, O2 saturation and/or blood gas and Chest x-ray, CBC, including inflammation markers and blood biometrics, ECG. Depending on the results: If the patient is an admission subsidiary, he is not included in the study. If the patient can be managed on an outpatient basis, meets all the criteria for inclusion and none for exclusion, data will be taken from the data collection sheet by the person responsible, verbal informed consent will be requested in front of witnesses and recorded in the medical record, and treatment will be assigned according to 1:1 randomization (established by order of inclusion). Group 1. Symptomatic treatment (paracetamol 1 g on demand) + Hydroxychloroquine + Azithromycin x 5 days Group 2. Symptomatic treatment + Hydroxychloroquine + Azithromycin + Prednisone The main result is admission after 30 days. Secondary outcomes are 30-day ICU admission and hospital stay. The safety variable will be the occurrence of outbre | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Spain
Contacts
Public ContactMaría Jesús Coma
Research Unit
Outcome results
None listed