The West Midlands Research Response to COVID19

Study Name

Summary/Description

Study Website (where available)/Online info

ADAPT-SEPSIS

BiomArker-guided Duration of Antibiotic treatment in hospitalised PaTients with suspected Sepsis. This is an existing study within the NIHR CRN Portfolio and a UK-wide multi-centre randomised controlled trial, which aims to determine whether treatment protocols based on monitoring daily CRP (C-reactive protein) or PCT (procalcitonin) safely allow a reduction in duration of antibiotic therapy in hospitalised adult patients with suspected sepsis. The addition of recruitment of COVID-19 patients to ADAPT-Sepsis will address an area of unmet research need.

https://warwick.ac.uk/fac/sci/med/research/ctu/trials/adaptsepsis

CATALYST

A Birmingham-led drugs trial testing potential treatments for patients in hospital with COVID-19

https://www.research.uhb.nhs.uk/major-covid-19-drugs-trial-begins-in-birmingham/

CLARITY

Impact of bioLogic therapy on saRs-cov-2 Infection and immunity (CLARITY).

The impact of immunosuppressive and immunomodulatory treatment on SARS-CoV-2 infection and disease severity is unknown, but is a major concern for patients and clinicians. Inflammatory bowel disease (IBD) affects about 1% of the UK population and is usually treated with immunosuppressive drugs. This study aims to define the impact of immunosuppressive drug therapy and physical distancing strategies on SARS-CoV-2 seroprevalence within this patient group. Although this study will define risk in IBD patients, there are potentially important lessons to be learned for millions of patients across the UK with other immune mediated diseases treated with similar therapies.

 https://www.clarityibd.org/

COG-UK HOCI study  

Hospitals are recognised to be a major risk for the spread of infections despite the availability of protective measures. Under normal circumstances, staff may acquire and transmit infections, but the health impact of within hospital infection is greatest in vulnerable patients. For the novel coronoavirus that causes COVID-19, like recent outbreaks such as the SARS and Ebola virus, the risk of within hospital spread of infection presents an additional, significant health risk to healthcare workers. Infection Prevention and Control (IPC) teams within hospitals engage in practices that minimise the number of infections acquired within hospital. This includes surveillance of infection spread, and proactively leading on training to clinical and other hospital teams. There is now good evidence that genome sequencing of epidemic viruses such as that which causes COVID-19, together with standard IPC, more effectively reduces within hospital infection rates and may help identify the routes of transmission, than just existing IPC practice. It is proposed to evaluate the benefit of genome sequencing in this context, and whether rapid (24-48h) turnaround on the data to IPC teams has an impact on that level of benefit. The study team will ask participating NHS hospitals to collect IPC information as per usual practice for a short time to establish data for comparison. Where patients are confirmed to have a COVID-19 infection thought to have been transmitted within hospital, their samples will be sequenced with data fed back to hospital teams during the intervention phase. A final phase without the intervention may take place for additional information on standard IPC practice when the COVID-19 outbreak is at a low level nationwide.  

https://www.cogconsortium.uk/studies/

COPCOV

The aim of the study is to determine if hydroxychloroquine prophylaxis prevents symptomatic COVID-19 infection in front-line health care workers. The study is a double-blind, randomised, placebo-controlled trial that will be conducted in healthcare settings. After obtaining fully informed consent, they will recruit front-line healthcare workers, who can be followed up reliably for up to 5 months. 

https://www.copcov.org/

COVID-HEART: Demographic, multi-morbidity and genetic impact on myocardial involvement and its recovery from COVID-19: a UK national study

The aims of this study are to characterise the prevalence and extent of myocardial involvement from COVID-19 infection, and to assess recovery status at 6 months. Additionally this study aims to understand the impact of this on patient quality of life and functional capacity for a UK population.

N/A

COVID-19 National DiagnOstic Research and Evaluation Platform (CONDOR) FALCON

This is a phase 2/3, participant-blinded individually randomised controlled trial in adults and healthy children in the UK, administering either a single dose or two doses of ChAdOx1 nCoV-19 vaccine or a licensed MenACWY vaccine via IM injection. Adult volunteers aged at least 18 years, and healthy children aged 5–12 years (inclusive) will be recruited into this study.

https://www.condor-platform.org/condor_workstreams/falcon

GenOMICC

This aim of this study is to

• identify genetic variants within patients which are associated with susceptibility to and mortality from life-threatening infection

• Prioritise therapeutics targets which modulate the patient’s response to the infection

https://genomicc.org/

ISARIC

A UK-wide consortium of doctors and scientists committed to answering urgent questions about COVID-19 :

• 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?

https://isaric4c.net/

MERMAIDS

This is a phase 2/3, participant-blinded individually randomised controlled trial in adults and healthy children in the UK, administering either a single dose or two doses of ChAdOx1 nCoV-19 vaccine or a licensed MenACWY vaccine via IM injection. Adult volunteers aged at least 18 years, and healthy children aged 5–12 years (inclusive) will be recruited into this study. Advertisements will be used to recruit volunteers.

https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/mermaids-ari/

Neo-Natal Complications of COVID-19

This is a national surveillance programme using the standard British Paediatric Surveillance Unit (BPSU) approach. This study will run alongside and be cross-linked with the maternal surveillance study run through the United Kingdom Obstetric Surveillance System (UKOSS - see below) which is already in progress. Observational study- will collect information about newborn babies who have coronavirus or who are born to mothers who have.

 N/A

PANCOVID

The aim of this study is to understand the natural history of COVID-19 in pregnancy, in order to guide treatment and prevention during the outbreak.

https://pan-covid.org/

(PHOSP-COVID) Post-hospitalisation COVID-19 study: a national consortium to understand and improve long-term health outcomes

The COVID-19 pandemic has had a major impact on the UK’s health, social care and economy. The long-term sequelae of COVID-19 after discharge from hospital in both those with and without comorbidities are unknown. A comprehensive patient-centred holistic study is required to determine the chronic health and health economic sequelae of COVID-19 infection in post-hospitalisation survivors. This will define demographic, clinical and molecular biomarkers of the susceptibility and inform our understanding of the impact of interventions during the acute illness. These insights will guide consequent in-depth studies to inform precision medicine in at risk groups by directing new clinical trials and care for current and future post-COVID-19 patients.

https://phosp.org/

PRINCIPLE

Aims to find out whether selected treatments given to people at higher risk of becoming more ill when they are infected with COVID-19 can help reduce the need for hospitalisation and the length of stay required, helping people recover quicker and with fewer complications. The trial is recruiting participants through GP practices across the UK. 

https://www.phctrials.ox.ac.uk/principle-trial

REALIST

The REALIST trial plans to test if treatment with a preparation of MSCs, called REALIST ORBCEL-C, can improve outcomes in patients with Acute Respiratory Distress Syndrome

https://www.hra.nhs.uk/covid-19-research/approved-covid-19-research/227090/

RECOVERY

Aims to identify treatments that may be beneficial for adults hospitalised with confirmed COVID-19. *Open to children from 9/5/20 

https://www.recoverytrial.net/

RECOVERY- Respiratory Support

Compare the effectiveness of three ventilation methods;

• Continuous positive airway pressure (CPAP): this treatment applies mild to high air pressure on a continuous basis through a tightly fitted face mask. It keeps the airways continuously open in people who are able to breathe normally on their own, but need help keeping their airway clear.

• High flow nasal oxygen (HFNO): this is a way of giving humidified (moistened) and warmed oxygen through tubes into the nose. The oxygen is delivered very quickly to help patients who have low oxygen levels and find breathing on their own difficult.

• Standard care: standard treatment will involve oxygen delivered via a normal face mask or tubes in the nose.

https://warwick.ac.uk/fac/sci/med/research/ctu/trials/recovery-rs

REMAP-CAP

This is an international randomised controlled trial, looking at the effect a number of different drugs has on those with significant community-acquired pneumonia.   It is targeted towards those who are in ICU

https://www.remapcap.org/

SIREN

This study aims to find out whether healthcare workers who have evidence of prior COVID-19, detected by antibody assays (positive antibody tests), compared to those who do not have evidence of infection (negative antibody tests) are protected from future episodes of infection.

https://snapsurvey.phe.org.uk/siren/

 STOP COVID-19

The overall objective of the study is to evaluate the clinical efficacy of Brensocatib compared to placebo on top of standard care in adult patients hospitalised with COVID-19.

 N/A

TACTIC

TACTIC plans to recruit patients at an early stage in the disease course, aiming for a timepoint where the patient is experiencing early infection and starting to show mild pulmonary complications. The purpose is to prevent organ damage and reduce the need to transfer to ICU and ventilation. T

https://www.nihr.ac.uk/news/tactic-new-national-trial-launched-to-find-covid-19-treatment/24851

UKOSS

COVID-19 in Pregnancy

https://www.npeu.ox.ac.uk/ukoss/current-surveillance/covid-19-in-pregnancy