SOLIDARITY PARTNERS trial
| ISRCTN | ISRCTN30355388 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30355388 |
| Secondary identifying numbers | Pan_filo_5.0 |
- Submission date
- 03/10/2024
- Registration date
- 04/10/2024
- Last edited
- 24/10/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
Some filoviruses are dangerous to humans and can make people very sick or cause them to die. Two diseases caused by them – Ebola and Marburg – have caused outbreaks in countries in Africa. When these outbreaks happen they can cause lots of damage in communities, and cause problems for the country like children being out of school and businesses closing. It is hard to know exactly when and where outbreaks will happen next. This makes it hard to develop treatments to fight them. The best way to find out if a drug works and is safe is to run a clinical trial. People agree to take part and some are given the vaccine or treatment. What they receive is decided at random (like tossing a coin) to ensure that the results are reliable. All participants are followed up to check for side effects and to find out what happens to them. The World Health Organization is organizing this clinical trial for filoviruses. It is called the SOLIDARITY PARTNERS trial and is focused on finding the best treatments for filoviruses.
Who can participate?
Patients of any age who have been admitted to a hospital or treatment unit for treatment of Ebola disease, Marburg disease, and unspecified and emergent filovirus diseases.
What does the study involve?
Participants in the study will have information collected about how they are feeling, what medications they are taking, and the results of any blood test (including Ebola or Marburg tests, malaria tests, liver and kidney tests, and if they are women - pregnancy tests that their doctors have ordered. A computer will then allocate participants at random (like rolling a die) to one (or sometimes more) of the study medicines. Neither the participant nor their doctors can choose which of these treatments will be allocated. Participants will then be given the study medicines. Participants will have some extra blood tests taken. These will be on the day they arrive, on days 3, 5, 7, 10, 13 and 16 of their stay (if they are still in the treatment unit) and on the day of discharge. Participants will then be followed up around day 28 and day 60 after entering the study. Pregnant women will be followed up to collect information on their and their baby’s health.
What are the possible benefits and risks of being in the study?
It is unknown if any of the treatments being tested will have additional benefits, so the study treatment may or may not help participants personally, but this study should help future patients. The study drugs may have side effects. The study team will monitor for side effects. Taking blood samples may cause soreness, bleeding or bruising where the needle went in.
Where is the study run from?
The study is being run by doctors from the World Health Organization and the Ministry of Health in countries affected by filovirus outbreaks.
When is the study starting and how long is it expected to run for?
February 2023 to December 2030
Who is funding the study?
The World Health Organisation.
Who is the main contact?
Prof Peter Horby, peter.horby@ndm.ox.ac.uk
Contact information
Scientific
Pandemic Sciences Institute, Nuffield Department of Medicine, University of Oxford
Old Road Campus, Roosevelt Drive.
Oxford
OX3 7BN
United Kingdom
 ORCID ID |
0000-0002-3948-0756 |
|---|---|
| Phone | +44 1865 270000 |
| amanda.rojek@ndm.ox.ac.uk |
Public
World Health Organisation, 20 Avenue Appia.
Geneva
CH-1211
Switzerland
| ORCID ID |
0000-0001-9910-7999 |
|---|---|
| Phone | +41 22 791 21 11 |
| henaorestrepoa@who.int |
Principal Investigator
CHUK MOH, KK Avenue 04
Kigali
KK 17
Rwanda
| Phone | +250788317487 |
|---|---|
| dturatsinzeh2001@yahoo.fr |
Scientific
Pandemic Sciences Institute, Nuffield Department of Medicine, University of Oxford
Old Road Campus, Roosevelt Drive.
Oxford
OX3 7BN
United Kingdom
| ORCID ID |
0000-0002-9822-1586 |
|---|---|
| Phone | +447785604877 |
| peter.horby@ndm.ox.ac.uk |
Study information
| Study design | Multi-country multi-outbreak randomized adaptive platform trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Laboratory, Medical and other records |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Platform Adaptive Randomised Trial for NEw and Repurposed Filovirus treatmentS (PARTNERS) |
| Study acronym | SOLIDARITY PARTNERS |
| Study hypothesis | To identify the effect of included therapies on all-cause mortality at 28 days after randomisation in patients admitted to a healthcare facility with filovirus disease. |
| Ethics approval(s) |
1. Approved 30/09/2024, National Ethics Committee of the Republic of Rwanda (Ministry of Health, P.O. Box 83, Kigali, NA, Rwanda; +250 2 55 10 78 84; info@rnecrwanda.org), ref: 117/RNEC/2024 2. Approved 01/12/2023, World Helth Organization Ethics Review Committee (20 Avenue Appia, Geneva, CH-1211, Switzerland; +41-22-7912111; henaorestrepoa@who.int), ref: CERC.0196 |
| Condition | Filovirus disease: including Ebola disease, Marburg disease, and unspecified and emergent filovirus diseases. |
| Intervention | This is a multi-country, multi-outbreak randomised adaptive platform trial of potential treatments for filovirus disease. This includes Ebola disease, Marburg disease, and unspecified and emergent filovirus diseases. The treatment comparisons included are determined by expert consultations convened by WHO. There are three treatment domains: 1. Monoclonal antibody 2. Small molecule antiviral 3. Host directed therapies The specific drug in each domain varies according to the particular filovirus. As a platform adaptive trial, the included agents may vary throughout the trial as new agents or new data become available. Randomisation is at 1:1 allocation between the ‘supportive care plus a candidate therapeutic’ and ‘supportive care with no additional treatment’ groups. A fully factorial design is used for each domain, so more than one independent randomisation can be undertaken simultaneously for a participant (one randomisation per domain, depending on the availability of candidate therapeutics in each domain). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Initial agents are remdesivir (small molecule antiviral) and MBP091 (monoclonal antibody specific for Marburg virus disease). |
| Primary outcome measure | All-cause mortality measured using patient medical records at 28 days following randomisation |
| Secondary outcome measures | Time (days) to Filovirus RNA <LLOQ (lower limit of quantitation) measured using real time reverse transcription-polymerase chain reaction within 28 days following randomisation |
| Overall study start date | 02/02/2023 |
| Overall study end date | 01/03/2031 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Lower age limit | 0 Days |
| Upper age limit | 110 Years |
| Sex | Both |
| Target number of participants | 500; Ideally, each comparison should be sufficiently large to provide good power (e.g. 90% power to achieve 2P=0.01) to detect a proportional reduction in mortality of at least one third. This may require randomisation of several hundred patients in each comparison. For example, if mortality in the reference arm was 50%12,18,19, randomisation of around 520 participants in a single comparison would give more than 90% power at 2P=0.01 to detect a proportional reduction in mortality of one-third and more than 80% power at 2P=0.05 to detect a smaller (but still useful) reduction in mortality of one-quarter. |
| Participant inclusion criteria | 1. Admitted to a hospital or treatment unit for treatment of filovirus disease 2. Positive Filovirus RT-PCR (or neonate aged seven days or younger born to a woman with acute laboratory-confirmed Filovirus Disease) 3. No medical history that might, in the opinion of the attending clinician, put the patient at significant risk if enrolled in the trial (e.g. known allergy to a study drug) 4. Not known to have been enrolled in this protocol previously |
| Participant exclusion criteria | Not meeting the participant inclusion criteria |
| Recruitment start date | 15/10/2024 |
| Recruitment end date | 31/12/2030 |
Locations
Countries of recruitment
- Rwanda
Study participating centre
Kigali
KK 17
Rwanda
Sponsor information
Research organisation
20 Avenue Appia
Geneva
CH-1211
Switzerland
| Phone | +41 22 791 21 11 |
|---|---|
| henaorestrepoa@who.int | |
| Website | https://www.who.int/about/contact-us |
"ROR" |
https://ror.org/01f80g185 |
Government
P.O. Box 84
Kigali
NA
Rwanda
| Phone | +250 577458 |
|---|---|
| info@moh.gov.rw | |
| Website | http://www.moh.gov.rw/ |
|
"ROR" |
https://ror.org/05prysf28 |
Funders
Funder type
Research organisation
Private sector organisation / International organizations
- Alternative name(s)
- منظمة الصحة العالمية, 世界卫生组织, Всемирная организация здравоохранения, Organisation mondiale de la Santé, Organización Mundial de la Salud, WHO, 世卫组织, ВОЗ, OMS
- Location
- Switzerland
Results and Publications
| Intention to publish date | 31/12/2031 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the study will be available on request from Prof Peter Horby, peter.horby@ndm.ox.ac.uk |
Editorial Notes
24/10/2024: The recruitment start date was changed from 14/10/2024 to 15/10/2024.
03/10/2024: Study's existence confirmed by the National Ethics Committee of the Republic of Rwanda.
