An international randomised trial of additional treatments for COVID-19 in hospitalised patients who are all receiving the local standard of care

Phase 1

• Conditions: COVID-19; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001366-11-IT
• Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-20
• Last Update Posted: 29 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100000

Inclusion Criteria

consenting adults (age =18) hospitalised with definite COVID-19, not already receiving any of the study drugs
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 500

Exclusion Criteria

known allergy or contra-indications to investigational products
anticipated transfer within 72 hours to a non-study hospital.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this core protocol is to compare the effects on major outcomes in hospital of the local standard of care alone versus the local standard of care plus one of four alternative anti-viral agents. <br><br>The primary objective of this large international randomised trial is to provide reliable estimates on any effects of these anti-viral treatments on in-hospital mortality in moderate and in severe COVID;Secondary Objective: The secondary objectives are to assess any effects of these anti-viral treatments on hospital duration and receipt of ventilation or intensive care, and to identify any serious adverse reactions.;Primary end point(s): The primary outcome is all-cause mortality, subdivided by severity of disease at the time of randomisation.;Timepoint(s) of evaluation of this end point: At discharge or death.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The major secondary outcomes are duration of hospital stay and time to first receiving ventilation (or intensive care).;Timepoint(s) of evaluation of this end point: At discharge or death.