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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 30 May 2020

At a glance

  • Drugs Chloroquine (Primary) ; Hydroxychloroquine (Primary) ; Interferon beta (Primary) ; Lopinavir/ritonavir (Primary) ; Lopinavir/ritonavir (Primary) ; Remdesivir (Primary) ; Remdesivir (Primary)
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Acronyms SOLIDARITY
  • Most Recent Events

    • 31 Mar 2020 New trial record

Trial Overview

Purpose

The addition of treatment to the local standard of care reduces all-cause mortality in COVID-19 patients compared to the local standard of care alone.

Primary Endpoints

All-cause mortality, subdivided by the severity of disease at the time of randomization, measured using patient records throughout the study

Other Endpoints

The major secondary outcomes are duration of hospital stay and time to first receiving ventilation (or intensive care). Timepoint: At discharge or death. [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 100000

  • Sex male & female
  • Age Group ≥ 18 years; adult; elderly

Patient Inclusion Criteria

consenting adults (age ≥18) hospitalised with definite COVID-19, not already receiving any of the study drugs

Patient Exclusion Criteria

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

Trial Details

Identifiers

Identifier Owner
EudraCT2020-001366-11 European Clinical Trials Database
83971151 ISRCTN: Current Controlled Trials
0003361 -
Solidarity -

Trial Dates

  • Initiation Dates

    Actual : 01 Mar 2020

  • End Dates

    Planned : 25 Mar 2021

Other Details

  • Design multicentre; open; prospective; randomised
  • Phase of Trial Phase III
  • Location Argentina; Australia; Brazil; Canada; France; Germany; Honduras; India; Indonesia; Iran; Ireland; Israel; Italy; Kenya; Lebanon; Malaysia; Norway; Peru; Philippines; Qatar; Saudi Arabia; South Africa; Spain; Switzerland; Thailand
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
ChloroquinePrimary Drug Oral Pill, Tablet
HydroxychloroquinePrimary Drug Oral Pill, Tablet
Interferon betaPrimary Drug Parenteral Injection
Lopinavir/ritonavirPrimary Drug Nasogastric Solution
Lopinavir/ritonavirPrimary Drug Oral Pill, Tablet
RemdesivirPrimary Drug Intracavernous Infusion
RemdesivirPrimary Drug Intravenous Infusion

Adults (aged ≥18 years) recently hospitalized, or already in the hospital, with definite COVID-19 and, in the view of the responsible doctor, no contra-indication to any of the study drugs will be randomly allocated between five groups:
1. Local standard of care alone
OR local standard of care plus one of
2. Remdesivir (daily infusion for 10 days)
3. Chloroquine or hydroxychloroquine (two oral loading doses, then orally twice daily for 10 days)
4. Lopinavir + ritonavir (orally twice daily for 14 days)
5. Lopinavir + ritonavir ((orally twice daily for 14 days) plus interferon-beta (daily injection for 6 days)

Follow-up is until death or discharge from hospital.
Randomization is performed at one central global location through an online portal.
Drug Names: Remdesivir, chloroquine or hydroxychloroquine, lopinavir + ritonavir (Kaletra), interferon-beta

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
-
Multiple hospital sites (to be confirmed), World Health Organization Switzerland
Dr Ana Maria Henao Restrepo
Medical Officer HQ/RDB R&D Blue Print (HQ/HEO/RDB) World Health Organization HQ Geneva 1211 Switzerland +41 795130039 henaorestrepoa@who.int http://orcid.org/0000-0001-9910-7999
show details
Medical Officer Switzerland
SCREN-UICEC
profesor martin lagos s/n
Madrid
Postcode: 28040
Spain
Telephone: +349133030007360
Fax: +34913303515
fibucicec.hcsc@salud.madrid.org
show details
FIB-HCSC Spain

Centres

Centre Name Location Trial Centre Country
-
-
Argentina
-
-
Brazil
-
-
Canada
-
-
Germany
-
-
Honduras
-
-
India
-
-
Indonesia
-
-
Iran
-
-
Ireland
-
-
Israel
-
-
Italy
-
-
Kenya
-
-
Lebanon
-
-
Malaysia
-
-
Norway
-
-
Peru
-
-
Philippines
-
-
Qatar
-
-
Saudi-Arabia
-
-
South-Africa
-
-
Spain
-
-
Thailand
FIB-HCSC Madrid Spain
Medical Officer Geneva Switzerland
Multiple hospital sites (to be confirmed)
-
Switzerland
World Health Organization Geneva Switzerland

Trial History

Event Date Event Type Comment
30 May 2020 Other trial event Last checked against Eudra record. Updated 30 May 2020
23 Apr 2020 Other trial event Last checked against ISRCTN record. Updated 23 Apr 2020
14 Apr 2020 Other trial event New source identified and integrated (European Clinical Trials Database;EudraCT2020-001366-11) Updated 14 Apr 2020
31 Mar 2020 New trial record New trial record Updated 31 Mar 2020

References

  1. European Clinical Trials Database. Trial-Reg 2016;.

    Available from: URL: https://www.clinicaltrialsregister.eu
  2. ISRCTN: Current Controlled Trials. Trial-Reg 2016;.

    Available from: URL: http://www.controlled-trials.com
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