| Study name |
Outpatient treatment of COVID‐19 with early pulmonary corticosteroids as an opportunity to modify the course of the disease (TAC‐COVID‐19) |
| Methods |
Trial design: open (phase IV) RCT
Sample size: 200
Setting: outpatient
Language: Spanish, English
Number of centres: no information
Type of intervention (treatment/prevention): treatment |
| Participants |
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‐ray with mild‐moderate or normal alterations Verbal informed consent in front of witnesses, reflected in medical records
Exclusion criteria
Desaturation < 93% or PO2 < 62 Moderate‐severe dyspnoea 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 > 300 mg/mL (fasting or not) -
Other significant co‐morbidities:
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
|
| Interventions |
Details of intervention: prednisone
Treatment details of control group (e.g. dose, route of administration): concomitant therapy
Concomitant therapy: symptomatic treatment + hydroxychloroquine + azithromycin |
| Outcomes |
Primary study outcome: 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: admission after 30 days |
| Starting date |
19 April 2020 |
| Contact information |
María Jesús Coma: 0034610620180
Email: mjcoma@hubu.es |
| Notes |
Recruitment status: ongoing
Prospective completion date: 3‐month estimated duration of trial
Date last update was posted: 20 April 2020
Sponsor/funding: Dra Ana Pueyo Bastida, Hospital Universitario de Burgos |
