Associated organisationsUniversity of Birmingham · University of OxfordEurope PMC affiliations are not treated as award recipients or mapped locations.
Funding£1.5M
PeriodAug 2020 — Dec 2021
In plain English
AI plain-English summary
A single injection of a common arthritis drug, given at home, could keep COVID-19 patients out of hospital. The drug is adalimumab, an anti-inflammatory medicine that blocks a protein called TNFα, which drives the dangerous immune overreaction seen in severe COVID-19. Most COVID-19 treatments are given late in the illness, often after a patient is already hospitalised. This trial tests whether giving the drug early, in community settings, can prevent progression to respiratory failure or death. The study uses a "hospital at home" model—teams of doctors and nurses delivering high-intensity care in patients' own homes, with point-of-care diagnostics. This approach mirrors healthcare systems in low- and middle-income countries, so the results could directly inform treatment delivery there. If successful, adalimumab could become a cheap, widely available, injectable therapy that reduces the need for oxygen, ventilation, and intensive care. The trial is a randomised dose-ranging study, meaning it will also identify the most effective dose. It addresses a pressing gap: the lack of proven treatments that can be delivered outside hospitals, early in the disease course.
View original technical description
While the first wave of COVID-19 is passing, we have yet to identify effective treatments. Most treatments have been used late in the illness. There is a pressing need to identify treatments delivered in community settings that avoid hospital admission. Novel immunomodulatory treatments have a well understood safety profile but are not suitable for studies such as Principle which rely on remote assessment. Hospital at home is a developing networ; teams of consultant physicians and nurses deliver high intensity care in community settings, commonly using point of care diagnostics. This provides a suitable framework for evaluation of novel therapies. This approach has parallels with healthcare systems employed in low and middle income countries and so the results will directly inform the delivery of interventions in these settings. Multiple strands of evidence identify TNFa as an important mediator of the hyperinflammatory state that is associated with poor outcome. Early intervention with anti-TNF therapy has the potential to substantially mitigate its effects and improve outcomes. Adalimumab is an established subcutaneous anti-TNF therapy. We propose a randomised dose ranging study in community settings to establish whether it can mitigate progression to respiratory failure (requirement for oxygen, non invasive and invasive ventilation) or death.
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