Status:
WITHDRAWN
Anti-inflammatory Drug Algorithm for COVID-19 Home Treatment
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Collaborating Sponsors:
Prime Care Physicians
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The newly recognised disease COVID-19 is caused by the Severe-AcuteRespiratory-Syndrome Coronavirus 2 (SARS-CoV-2), which rapidly spread globally in late 2019, reaching pandemic proportions. The clini...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05249790
Start Date
February 24 2022
End Date
February 24 2022
Last Update
November 29 2024
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