Platform Adaptive Randomised Trial for NEw and Repurposed Filovirus treatmentS (PARTNERS)
Filovirus disease: including Ebola disease, Marburg disease, and unspecified and emergent filovirus diseases.
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).
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
Not meeting the participant inclusion criteria