Multi-arm randomized trial, comparing the efficacy of therapeutic strategies for at home early treatment of mild or moderate COVID-19 (SARS-CoV-2 infection) patients on the reduction of the risk of disease worsening

Phase 1

• Conditions: Mild or moderate COVID-19 (Coronavirus Disease 19), not requiring hospitalization; MedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862; MedDRA version: 20.0Level: PTClassification code 10070255Term: Coronavirus test positiveSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-005890-29-IT
• Lead Sponsor: FONDAZIONE RICERCA TRASLAZIONALE (FORT)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-22
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 810

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>• Evaluate the frequency of nasopharyngeal swab positive patients at the end of the experimental treatment in the 3 treatment arms<br>• 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 Outcome Measures

Name	Time	Method
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