SOLIDARITY PARTNERS trial
| ISRCTN | ISRCTN30355388 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30355388 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Pan_filo_5.0 |
| Sponsors | World Health Organization, Ministry of Health |
| Funder | World Health Organization |
- Submission date
- 03/10/2024
- Registration date
- 04/10/2024
- Last edited
- 17/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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 2024
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
Level 1, Big Data Institute, Old Road Campus
Oxford
OX3 7LF
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
Level 1, Big Data Institute, Old Road Campus
Oxford
OX3 7LF
United Kingdom
| ORCID ID |
0000-0002-9822-1586 |
|---|---|
| Phone | +447785604877 |
| peter.horby@ndm.ox.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multi-country multi-outbreak randomized adaptive platform trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Platform Adaptive Randomised Trial for NEw and Repurposed Filovirus treatmentS (PARTNERS) |
| Study acronym | SOLIDARITY PARTNERS |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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(s) |
All-cause mortality measured using patient medical records at 28 days following randomisation |
| Key secondary outcome measure(s) |
Time (days) to Filovirus RNA <LLOQ (lower limit of quantitation) measured using real time reverse transcription-polymerase chain reaction within 28 days following randomisation |
| Completion date | 29/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Lower age limit | 0 Days |
| Upper age limit | 110 Years |
| Sex | All |
| Target sample size at registration | 500 |
| Total final enrolment | 5 |
| Key inclusion criteria | 1. Admitted to a hospital or treatment unit for treatment of filovirus disease 2. Positive Filovirus RT-PCR (or neonate aged 7 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 |
| Key exclusion criteria | Not meeting the participant inclusion criteria |
| Date of first enrolment | 15/10/2024 |
| Date of final enrolment | 29/12/2024 |
Locations
Countries of recruitment
- Rwanda
Study participating centre
Kigali
KK 17
Rwanda
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/11/2025: The following changes were made to the study record:
1. Contact details updated.
2. The completion date was changed from 01/03/2031 to 29/12/2024.
3. Total final enrolment added.
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.
