COVID-19 Algorithm Treatment at Home (COVER-HOME)
COVID-19
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19 treatment at home, Early symptoms, Hospitalization, Anti-inflammatory drugs
Eligibility Criteria
Inclusion Criteria:
- Male and female adult (≥18 years old)
Subjects with early mild/moderate symptoms of COVID-19*, who start the treatment without waiting results of a nasopharyngeal swab**
* Influenza-like syndrome, (i.e. flu, cough, myalgias/arthralgias or other painful symptoms, fever, gastrointestinal symptoms), no dyspnea, SpO2 >94%, or asthenia,ageusia/dysgeusia, anosmia, or MEWS 0 to 3.
** Nasopharyngeal swab should be performed soon after the onset of symptoms possibly related to SARS-CoV-2
- Subjects without known comorbidities in their previous medical history
- Subjects with known comorbidities that bring them at high risk of COVID-19 progression (heart disease, hypertension, asthma or lung disease, diabetes, chronic kidney disease, stroke or neurological problems, weakened immune system - e.g. receiving chemotherapy -, and self-reported obesity or body-mass index of at least 30 kg/sqm)
- Informed consent
Exclusion Criteria:
- Subjects who require immediate hospital admission because of severe COVID-19 symptoms at onset according to family doctor's assessment (MEWS score 5, and/or septic shock, multiorgan failure)
- Known hypersensitivity or allergy to any medication under investigation
- Specific contraindications to the use of each recommended drugs according to their summary of product characteristics and the clinical judgment of family doctor
- Legal incapacity, limited legal incapacity, intellectual disability, uncooperative attitude or any other evidence that the patient will not be able to understand the study aims and procedures
- Pregnancy* (*Patient with childbearing potential will be included according to the pragmatic design of the study)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
'Recommended algorithm' cohort
Usual care
COVID-19 patients treated at home by their family doctors according to the proposed recommendations
COVID-19 patients treated at home by their family doctors according to their usual clinical practice expected to be in accordance with AIFA recommendations