Mild or moderate COVID-19 (Coronavirus Disease 19), not requiring hospitalization MedDRA version: 23.0 Level: LLT Classification code 10053983 Term: Corona virus infection System Organ Class: 100000004862 MedDRA version: 20.0 Level: PT Classification code 10070255 Term: Coronavirus test positive System Organ Class: 10022891 - Investigations
Conditions
Interventions
Product Name: Paracetamolo
Product Code: [Paracetamolo]
Pharmaceutical Form: Tablet
INN or Proposed INN: PARACETAMOLO
Current Sponsor code: Paracetamolo
Other descriptive name: Paracetamol
Concentrati
Sponsors
FONDAZIONE RICERCA TRASLAZIONALE (FORT)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age from 35 to 80 years 2. Confirmed SARS-CoV-2 infection, (evidence of infection obtained by COVID-19 swab test prior to consent signing is accepted) 3. Patients with mild / moderate symptoms with at least fever and / or painful manifestations such as headache, muscle aches, sore throat, and in addition vomiting and/or diarrhea. 4. Signing informed consent 5. For female patients: statement of menopausal status or absence of pregnancy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 570 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 240
Exclusion criteria
Exclusion criteria: 1. Age less than 35 years old 2. 80 years old in the year of enrollment 3. Clinical condition requiring steroid therapy 4. Mechanical ventilation needed 5. Pregnancy and breastfeeding 6. Severe electrolyte imbalances 7. History of ventricular cardiac arrhythmias 8. Known renal insufficiency (CcCl <30 mL / min or patient on CCRT, haemodialysis or peritoneal dialysis) 9. Oncological, haemato-oncological, haematological and / or hepatic disease 10. Retinal disease, or hearing loss 11. Mental illness 12. Skin disorders (including skin rash, dermatitis, psoriasis) 13. Patients already on anticoagulant treatment with high / low molecular weight heparins or other parenteral anticoagulants 14. Patients at high venous thromboembolic risk according to the Padua score already on prophylaxis with low molecular weight heparin or unfractionated heparin 15. Patients with indications for treatment with oral anticoagulants 16. Patients on chronic treatment with non-steroidal anti-inflammatory drugs (NSAIDs) 17. Patients being treated with antivirals 18. Patients treated with monoclonal antibodies with direct action on cytokines 19. Patients being treated with chloroquine / hydroxychloroquine 20. Intolerance to study drugs 21. Immunosuppressive therapy in progress or in the last month. 22. Patients with severe hepatocellular insufficiency 23. Patients with ulcerative colitis or Crohn's disease 24. Patients with increased bleeding risk: • Congenital and acquired haemorrhagic diseases • Thrombocytopenia (<25,000 / mm3) • Bleeding in progress • Previous heparin thrombocytopenia 25. Women of childbearing age who do not use contraceptives 26. Participation in other interventional or observational clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Identify the most suitable therapeutic scheme to reduce the risk of disease progression towards respiratory failure in paucisymptomatic patients affected by SARS-CoV-2 infection treated at home;Secondary Objective: • Assess the frequency of hospitalizations in the 3 treatment arms • Evaluate the frequency of nasopharyngeal swab positive patients at the end of the experimental treatment in the 3 treatment arms • Compare safety and tolerability associated with therapeutic regimens proposed in paucisymptomatic patients with SARS-CoV-2 infection treated at home; for patients on treatment with heparins, evaluate the onset of vascular disorders;Primary end point(s): Percentage of patients with worsening of disease symptoms and signs 5-10 (±2) days after initiation of therapy (baseline), i.e. transition from mild to moderate or severe or critical disease, or from moderate to severe disease criticism.;Timepoint(s) of evaluation of this end point: 5 and 10 (±2) days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Percentage of patients hospitalized within 5 and 10 (±2) days of the start of therapy (baseline) in the 3 treatment arms; • Percentage of patients positive for nasopharyngeal swab at 10 (± 2) days from the start of treatment; • Grade 2-5 treatment-related adverse events (moderate, severe, very severe related events and deaths), serious adverse events or treatment discontinuation due to toxicity in the 3 treatment arms (safety and tolerability);Timepoint(s) of evaluation of this end point: 5 and 10 (±2) days; 10 (±2) days; 15 days | — |
Countries
Italy
Contacts
Public ContactClinical Operations
Clinical Research Technology
Outcome results
None listed