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

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001366-11-IE

Enrollment

100000

Registered

2020-04-17

Start date

2020-05-15

Completion date

Unknown

Last updated

2021-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Interventions

Trade Name: Gilvec Product Name: glivec Pharmaceutical Form: Tablet Trade Name: Infliximab Remicade Pharmaceutical Form: Powder and solvent for concentrate for solution for infusion Trade Name: Arte

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: o adults (age =18 years, which allows consent), o recently hospitalised (or already in hospital) with laboratory-confirmed COVID, o not expected to be transferred within 72 hours, o with, in the view of their doctors, no contra-indication to any potentially relevant study drug. 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

Exclusion criteria: Under 18 years of age Known allergy or contra-indications to any of the investigational products Anticipated transfer within 72 hours to a non-study hospital. Positive Pregnancy test

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary outcome is in-hospital mortality from any cause, and the primary analyses are of mortality in all randomised patients It is not expected that any of the treatments currently being tested will have a large effect on the risk of death, but if any had just a moderate effect and was widely practicable then this could avoid large numbers of deaths. ects of these anti-viral treatments on in-hospital mortality in moderate and in severe COVID;Secondary Objective: The major secondary outcomes are initiation of ventilation, and duration of hospital stay. The main safety analyses will be of reported SAEs and SUSARs possibly related to the treatment and SUSARs. ;Primary end point(s): The primary outcome is all-cause mortality, subdivided by severity of disease at the time of randomisation. The main secondary analyses will assess in-hospital mortality subdivided by initial respiratory support. Further secondary analyses will assess initiation of ventilation in lower-risk patients, and, separately, duration of hospital stay in lower-risk patients (A-B) and in higher-risk patients (C-F). ;Timepoint(s) of evaluation of this end point: At discharge from hospital or death.	—

Measure

Time frame

Main Objective: The primary outcome is in-hospital mortality from any cause, and the primary analyses are of mortality in all randomised patients It is not expected that any of the treatments currently being tested will have a large effect on the risk of death, but if any had just a moderate effect and was widely practicable then this could avoid large numbers of deaths. ects of these anti-viral treatments on in-hospital mortality in moderate and in severe COVID;Secondary Objective: The major secondary outcomes are initiation of ventilation, and duration of hospital stay. The main safety analyses will be of reported SAEs and SUSARs possibly related to the treatment and SUSARs. ;Primary end point(s): The primary outcome is all-cause mortality, subdivided by severity of disease at the time of randomisation. The main secondary analyses will assess in-hospital mortality subdivided by initial respiratory support. Further secondary analyses will assess initiation of ventilation in lower-risk patients, and, separately, duration of hospital stay in lower-risk patients (A-B) and in higher-risk patients (C-F). ;Timepoint(s) of evaluation of this end point: At discharge from hospital or death.

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Secondary

Measure	Time frame
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.	—

Countries

Australia, Canada, France, India, Ireland, Italy, Latvia, Lithuania, Norway, Portugal, Romania, Slovakia, Spain

Contacts

Public ContactChief Investigator

University College Cork

j.eustace@ucc.ie

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026