An international randomised trial of additional treatments for COVID-19 inhospitalised 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-RO
• Lead Sponsor: Ministry of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-22
• Last Update Posted: 25 April 2022

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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 800

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<br>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<br>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<br>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.