Comparative efficacy of therapeutic strategies for at home early treatment of mild or moderate COVID-19 patients on the reduction of the risk of disease worsening:A multi-stage multi-arm adaptive randomized cluster trial - Early Treatment of COVID-19 infection – The ETC study

FONDAZIONE RICERCA TRASLAZIONALE (FORT)0 sites810 target enrollmentMarch 22, 2021

Overview

No summary available.

Registry

who.int

Start Date

March 22, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

FONDAZIONE RICERCA TRASLAZIONALE (FORT)

•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

•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