Status:
WITHDRAWN
COVID-19 Algorithm Treatment at Home
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The newly recognised disease COVID-19 is caused by the Severe-Acute-Respiratory-Syndrome Coronavirus 2 (SARS-CoV-2), which rapidly spread globally in late 2019, reaching pandemic proportions. The clin...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05413642
Start Date
July 1 2023
End Date
February 6 2024
Last Update
February 14 2024
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