The Society has been a long-term supporter of many of these studies which are now at the forefront of UK research against COVID-19 and is incredibly proud of both the pro-active and reactive research being undertaken by its Directors of Research.
Please assist where you can with this vital research and sign up to participate in any study possible to ensure this research continues.
The ISARIC 4C
The ISARIC 4C 4C (Coronavirus Clinical Characterisation Consortium) group is a leading consortium of professionals focused on improving our understanding of COVID-19. They are focussed on answering the following questions:
- How long are people infectious, and what body fluids are infectious?
- What puts people at higher risk of severe illness?
- What is the best way to diagnose the disease?
- Who should we treat early with drugs, and which drugs cause harm?
- Does the immune system in some patients do more harm than good?
- What other infections (such as pneumonia or flu) happen at the same time?
The UK needs a coordinated response to answer these questions as quickly as possible. Over the past nine years the Consortium have been preparing for a major outbreak, such as COVID-19, worldwide and the team deployed immediately and has been collecting data and samples since the first cases were reported in the UK.
You can find out more here. (https://isaric4c.net/)
Funding
ISARIC 4C is funded by a grant from UKRI (MRC) with a total value of £5.9 million to JK Baillie (PI), University of Edinburgh; MG Semple, University of Liverpool; and P Openshaw, Imperial College London (co-leads).
GenOMICC
Dr Kenneth Baillie - Intensive Care Society Director of Research
Professor Danny MacAuley - Intensive Care Society Director of Research
Genetic study, consent needed
GenOMICC (MRC/DHSC/FEAT/ICS/Wellcome-funded) is a UK-wide ICU study to identify variants underlying genetic susceptibility to critical illness with COVID-19, which may help identify new targets for treatment and mechanisms of disease. This study was funded in 2014 and was recruiting across the UK before the pandemic hit.
GenOMICC is now an NIHR urgent public health study and all COVID-19 patients are eligible to participate. So far there are 115 critical care units already signed up and we would encourage those who are yet to do so participate in this trial as soon as possible - https://genomicc.org/
RECOVERY – respiratory support
Professor Danny MacAuley - Intensive Care Society Director of Research
Randomised Evaluation of COVID-19 Therapy (MRC/DHSC-funded) is a trial of widely available, high-priority interventions, among confirmed COVID-19 cases requiring hospital admission, to determine effect on likelihood of death or requirement for invasive ventilation. Interventions will be added and removed over time as needed. Given the unprecedented impact COVID-19 will have on the health of the population, even small clinical benefits may be of significant benefit. Designed to give individual patients the best chance of getting an effective therapy. To do this we need GCP-trained research nurses to support front-line clinical staff recruiting patients.
RECOVERY-RS is a multi-centre, pragmatic clinical trial evaluating the use of CPAP and/or high flow nasal oxygenation to prevent intubation and reduce mortality. Uncertainty about the effectiveness of CPAP/HFNO in COVID-19 have led to conflicting guidance on the use of these interventions.
Since the trial was commissioned by the CMO’s office and is supported by the Intensive Care Society it has been made an urgent Public Health research priority (issued on 13 April, 2020).
The trial is seeking to recruit 4000 patients with acute respiratory impairment (FiO2 >0.4 and SpO2 < 94%). Sites may choose to enrol in one or both arms of the trial (CPAP versus standard care, HFNO versus standard care or CPAP versus HFNO versus standard care).
For more information and to sign up to participate in this trial please click the link: http://www.isrctn.com/ISRCTN16912075
REMAP-CAP: a platform trial for severely ill patients with COVID-19
Professor Anthony Gordon - Intensive Care Society Director of Research
REMAP-CAP (www.remapcap.org embed link) is an international adaptive platform trial specifically designed to be employed in a pandemic to evaluate multiple interventions simultaneously in critically ill patients. In the UK the trial is being led by Tony Gordon in conjunction with ICNARC. It has received UHP badging by the CMOs office and is listed as one of the UK’s prioritised platform trials.
Designed to generate answers quickly
REMAP-CAP can recruit easily. The bedside clinician can enrol patients in minutes. The trial is a Bayesian adaptive platform trial, generating answers to many questions rapidly.
- The platform is multi-factorial: each patient can be randomised to multiple treatments.
- It uses frequent interim analyses: a question is concluded as soon as there is sufficient information to support a conclusion. Analysis can occur every week.
- It detects superiority, inferiority, or equivalence of interventions within the platform.
- Additional interventions are added, as required, based on availability and external evidence.
- By assigning patients to 'recipes' of treatments, only a few patients receive no active therapy.
Current treatments:
REMAP-CAP will study, on an open-label basis:
- Antiviral therapy (no antiviral, lopinavir/ritonavir (Kaletra), hydroxychloroquine and the combination of both).
- Corticosteroid strategy (no steroid, fixed 7 days, only while in septic shock).
- Immune modulation (no modulator, interferon-beta, anakinra, and interleukin 6 inhibitors are being added).
- Convalescent plasma is being added (led by Manu Shankar-Hari & David Menon with NHSBT).
- Other interventions are in development.
The platform can evaluate interactions, for example, do steroids work only when an active antiviral is administered?
Designed to improve outcome for participants
The platform uses response adaptive randomisation. After each interim analysis, the weighting of randomisation is modified so that patients are more likely to receive those interventions that are performing best.
The protocol design has now been published.
If your ICU would like to sign up please contact: [email protected].