Anti-inflammatory Drug Algorithm for COVID-19 Home Treatment (COVER3)
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:
Subjects with early mild/moderate symptoms of COVID-19*, who start the treatment without waiting results of a nasopharyngeal swab, if any**
* 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 with or without comorbidities that bring the patients 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/m2)
- 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.
In the context of a pragmatic design, novel therapeutic options including monoclonal antibodies or antiviral medications that are expected to become part of every day clinical practice will be allowed, without restriction, in both treatment arms. Thus they are expected to be similarly distributed among patients allocated to the recommended treatment approach or to standard of care group. This should avoid any risk of bias related to an unbalanced distribution of these medications between treatment arms. Moreover, sensitivity analyses including or not including patients receiving these medications will allow to assess whether and to what extent they will have an impact (if any) on study findings.
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