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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001366-11-ES

Enrollment

100000

Registered

2020-03-26

Start date

2020-03-27

Completion date

Unknown

Last updated

2021-03-08

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

Conditions

COVID-19

Interventions

Product Name: Remdesivir Pharmaceutical Form: Lyophilisate for solution for infusion INN or Proposed INN: REMDESIVIR Current Sponsor code: REMDESIVIR Other descriptive name: REMDESIVIR Concentration u

Eligibility

Sex/Gender

All

Inclusion criteria

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 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2000

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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. 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.	—

Measure

Time frame

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. 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.

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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

Ireland, Italy, Latvia, Lithuania, Portugal, Romania, Slovakia, Spain

Contacts

Public ContactSCREN-UICEC

FIB-HCSC

fibucicec.hcsc@salud.madrid.org+349133030007360

Outcome results

None listed

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