Lancashire Clinical Trials Unit

STIMULATE-ICP is a pragmatic, multi-centre, cluster randomised trial of an integrated care pathway. The project has a nested, Phase III, open label, adaptive platform randomised drug trial in individuals with Long COVID.

STIMULATE-ICP is a pragmatic cluster (primary care network-level)-randomised trial aiming to evaluate integrated care pathway combinations with early, supported investigation (multi-organ MRI with Coverscan™ and clinical decision support) and enhanced rehabilitation (Living with COVID Recovery™), compared with usual care (Usual Investigations and Your COVID Recovery™ self-management), recruiting more than 4500 adults with suspected Long COVID at referral.

In a nested, patient-level adaptive platform, Phase III drug trial, the trial aims to investigate Colchicine vs. Rivaroxaban vs. Famotidine plus Loratadine in combination versus standard of care, with the option to test further drugs using an adaptive platform.

The trial will be assessing the efficacy of a 12- week treatment on symptoms, mental health, return to work and other important outcome measures.

Long COVID is a new disease or syndrome, and mechanisms of disease and potential mechanisms of new treatments need to be analysed. Baseline blood samples will be taken from all willing participants in the study to allow our team to look at the underlying disease processes. This will involve standard clinical tests (e.g., haematology and biochemistry) as well as looking at research areas such as genomics. Samples will be stored to develop a biobank for use by the broader global research community in the largest study of long COVID patients to-date.