Completed Lungs & Breathing Infection & Immunity

AVID-CC Adalimumab for COVID19 in community care

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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Researchers

Daniel Lasserson (EPMC Awardee)Duncan Richards (EPMC Awardee)Jonathan Cook (EPMC Awardee)Marc Feldmann (EPMC Awardee)Matthew Rowland (EPMC Awardee)

Related Research

Grants with similar aims, by meaning.

PROphylactic TrEatment of COVID in Care Homes Trial (PROTECT-CH)
An International Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Outpatients in Early Stages of COVID-19
Agile CST-2: A Randomized, Multicentre, Seamless, Adaptive, Phase I/II Platform Study to Determine the optimal dose, Safety and Efficacy of EIDD-2801 (molnupiravir) for the Treatment of COVID-19
Multi-arm trial of Inflammatory Signal Inhibitors for COVID-19 (MATIS)
A Randomised, Multicentre, Seamless, Adaptive Phase Ib/II Platform Trial to Determine the recommended Phase II dose and Evaluate the Safety and Efficacy of ALG-097558 as monotherapy and in combination with Remdesivir for the Treatment of mild-to-moderate COVID-19 disease

Original classification

Therapeutics Accelerator

Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.