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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: 18 Aug 2020

At a glance

  • Drugs Interferon beta-1a (Primary) ; Remdesivir (Primary)
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Acronyms SOLIDARITY
  • Most Recent Events

    • 18 Aug 2020 According to a Faron Pharmaceuticals media release, in July, WHO took the decision to remove the hydroxychloroquine and lopinavir/ritonavir treatment arms from the trial due to insufficient evidence of benefit. This leaves IFN beta-1a and remdesivir as the only two drugs remaining in the trial, subject to WHO announcing further new compounds for inclusion.
    • 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
CTRI2020-04-024773 Clinical Trials Registry - India
EudraCT2020-001366-11 European Clinical Trials Database
IRCT20200405046953N1 Iranian Registry of Clinical Trials
83971151 ISRCTN: Current Controlled Trials
0003361 -
ERC0003361 -
ISRCTN83971151 -

Organisations

  • Affiliations Faron Pharmaceuticals

Trial Dates

  • Initiation Dates

    Actual : 01 Mar 2020

  • End Dates

    Planned : 25 Mar 2021

Other Details

  • Design multicentre; open; parallel; 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
Interferon beta-1aPrimary Drug Intravenous Injection
RemdesivirPrimary Drug Intracavernous 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. Interferon-beta 1a (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, interferon-beta 1a

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
18 Aug 2020 Other trial event According to a Faron Pharmaceuticals media release, in July, WHO took the decision to remove the hydroxychloroquine and lopinavir/ritonavir treatment arms from the trial due to insufficient evidence of benefit. This leaves IFN beta-1a and remdesivir as the only two drugs remaining in the trial, subject to WHO announcing further new compounds for inclusion. Updated 26 Aug 2020
04 Aug 2020 Other trial event New source identified and integrated Iranian Registry of Clinical Trials (IRCT20200405046953N1) Updated 04 Aug 2020
30 Jul 2020 Other trial event New source identified and integrated(Clinical Trials Registry - India;CTRI2020-04-024773). Updated 30 Jul 2020
30 Jul 2020 Other trial event Last checked against Eudra record. Updated 30 Jul 2020
29 Jul 2020 Other trial event Last checked against ISRCTN record. Updated 29 Jul 2020
27 Jul 2020 Other trial event Recruitment completion is expected on 28 Feb 2021, according to ISRCTN: Current Controlled Trials. Updated 29 Jul 2020
27 Apr 2020 Other trial event According to a Faron Pharmaceuticals media release, the Company will donate supplies of its investigational intravenous (IV) interferon (IFN) beta-1a for 2,000 patients in the World Health Organization's (WHO) Solidarity trial. Updated 31 Aug 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. Faron Pharmaceuticals. Faron Pharmaceuticals Oy- Traumakine update. Media-Rel 2020;.

    Media Release
  3. ISRCTN: Current Controlled Trials. Trial-Reg 2016;.

    Available from: URL: http://www.controlled-trials.com
  4. Iranian Registry of Clinical Trials. Trial-Reg 2016;.

    Available from: URL: http://www.irct.ir/
  5. Clinical Trials Registry - India. Trial-Reg 2016;.

    Available from: URL: http://ctri.nic.in/
  6. Faron Pharmaceuticals. Traumakine to be a part of WHO's Solidarity trial investigating potential COVID-19 treatments. Media-Rel 2020;.

    Media Release
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