COVID-19 studies

Covid 19

Nationally prioritised and/or expedited studies open at Southampton

 

See the National Institute for Health Research (NIHR) list of all national priority studies here.

RECOVERY

Full title: Randomised evaluation of COVID-19 therapy

Comparison of existing HIV treatment (Lopinavir-Ritonavir) and antiinflammatory steroid (dexamethasone) in treating COVID-19.

Local PI: Dr Sophie Fletcher
Contact: thea.sass@uhs.nhs.uk or 023 8120 8141

Trial website: www.recoverytrial.net 

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REMAP-CAP

Full title: A Randomised, Embedded, Multi-factorial, Adaptive Platform Trial for Community-Acquired Pneumonia

 

A multi-centre international adaptive platform trial of critically ill patients with community acquired pneumonia, including COVID-19. It has multiple domains to evaluate multiple interventions simultaneously, including antivirals and immunomodulators, and will also evaluate potential interactions.

Local PI: Dr Ahilanandan Dushianthan
Contact: COVID19Research@uhs.nhs.uk

Trial website: www.remapcap.org

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COV0001: Oxford COVID-19 vaccine trial (phase 1/2)

Full title: A phase I/II study to determine efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in UK healthy adult volunteers

The study will enable to assess if healthy people can be protected from COVID-19 with this new vaccine called ChAdOx1 nCoV-19. It will also give us valuable information on safety aspects of the vaccine and its ability to generate good immune responses against the virus.

Local PI: Prof Saul Faust

COV0002: Oxford-AstraZeneca vaccine trial (phase 2/3)

Full title: A phase 2/3 study to determine the efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19

This study will enable us to assess how well people of all ages can be protected from COVID-19 with this new vaccine called ChAdOx1 nCoV-19. It will also give us valuable information on safety aspects of the vaccine and its ability to generate good immune responses against the virus.

Local PI: Prof Saul Faust

COVAC1 vaccine trial

Full title: A first-in-human clinical trial in healthy young and elderly adults to assess the safety, immunogenicity and exploratory evaluation of efficacy of a self-amplifying ribonucleic acid (saRNA) vaccine encoding the S glycoprotein of SARS-CoV-2, the causative agent of COVID-19 (COVAC1)

 

This is the first-in-human trial of LNP-nCoVsaRNA vaccine in healthy adults, to be performed in three parts. It is planned to enrol at least 140 subjects into Parts 1 and 2 per-protocol analysis set.

It is expected (providing no adverse safety signal is detected during this trial) that a sample size of 140 per-protocol participants completing this protocol will provide an immunogenicity and safety data set sufficient to support the initiation of a larger Pivotal Efficacy Trial.

Local PI: Prof Saul Faust

NOVAVAX vaccine trial

Full title: A Phase 3, Randomised, Observer-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1™ Adjuvant in Adult Participants 18-84 Years of Age in the United Kingdom

Local PI: Prof Saul Faust

ENSEMBLE 2: Janssen vaccine trial

Full title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older

Local PI: Prof Saul Faust

VLA2001: Valneva vaccine trial

Full title: A phase I/II randomized, two parts, dose-finding study to evaluate the safety, tolerability and immunogenicity of an inactivated, adjuvanted SARS-CoV-2 virus vaccine candidate (VLA2001), against COVID-19 in healthy subjects

Local PI: Prof Saul Faust

PROVENT vaccine trial

Full title: A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Pre-exposure Prophylaxis of COVID-19

Local PI: Prof Saul Faust

STORM CHASER vaccine trial

Full title: A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Post-exposure Prophylaxis of COVID-19

Local PI: Prof Saul Faust

 

ACCORD

Full title: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID 19 in Hospitalised Patients

There are currently no approved therapeutic agents available to treat coronaviruses such as severe acute respiratory syndrome coronavirus 2 (SARS CoV 2), the causative agent of COVID 19 disease, and there is an urgent public health need for rapid development of such interventions.

This adaptive platform study is designed to rapidly assess multiple candidate agents as treatments for COVID 19. 

Six potential drugs will initially enter the programme, with the first three of these beginning Phase 2 studies, which assess how well they work and their safety. Those showing promise will be fed into UK's large-scale COVID-19 studies such as the RECOVERY trial.

Local PI: Prof Tom Wilkinson
Contact: accord@uhs.nhs.uk

Find out more: www.accord-trial.org/

ISARIC

Full title: Clinical Characterisation Protocol for Severe Emerging Infection

This study is designed for the rapid, coordinated clinical investigation of patients with confirmed novel coronavirus infection. The study has been designed to maximize the likelihood that as much data as possible is collected and shared rapidly in a format that can be easily aggregated, tabulated and analysed across many different settings globally. The study is designed to have some level of flexibility in order to ensure the broadest acceptance.

Local PI: Dr Ahilanandan Dushianthan
Contact: COVID19Research@uhs.nhs.uk

ImmunoCOVID

Online questionnaire monitoring coronavirus infection children and adults vulnerable to infection.

Local PI: Dr Hans de Graaf

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SARS-CoV-2 infection

A randomised double-blind placebo-controlled trial to determine the safety and efficacy of inhaled SNG001 (IFN-β1a for nebulisation) for the treatment of patients with confirmed SARS-CoV-2 infection.

Local PI: Prof Tom Wilkinson

What's the STORY

Prevalence of viral antibodies in the child-age population (0 – 24 years) through analysis of routine blood samples, expanding to include COVID-19.

Local PI: Prof Saul Faust

Study website: whatsthestory.web.ox.ac.uk

GenOMICC

Full title: Genetics of susceptibility and mortality in critical care

Susceptibility to COVID-19 is almost certainly, in part, genetic. GenOMICC can find the genes that cause susceptibility, which may help us to prioritise treatments to respond to the global crisis. GenOMICC was designed for this crisis. Since 2016, the open, global GenOMICC collaboration has been recruiting patients with emerging infections, including COVID-19. All patients with confirmed COVID-19 in critical care are eligible for GenOMICC.

 

Local PI: Dr Rebecca Cusack

UKOSS: Pandemic Influenza in Pregnancy

Full title: Maternal and Perinatal Outcomes of Pandemic Influenza in Pregnancy

The study will use the UK Obstetric Surveillance System (UKOSS) to collect information about all pregnant women admitted to hospital who are confirmed to have the virus infection. Specifically, the study will describe incidence, management and outcomes of COVID-19 in pregnancy and identify factors associated with better outcomes for women and their babies.

Local PI: Dr Nazia Irsnad

DIAMONDS Search

Full title: Diagnosis and Management of Febrile Illness using RNA Personalised Molecular Signature Diagnosis

The overall aim of DIAMONDS is to design new diagnostic tests that can tell quickly and accurately what illness a patient has when they come to hospital with common symptoms such as fever. It is recruiting children and adults of all ages with suspected and proven COVID-19.  

Local PI: Prof Saul Faust

Remdesivir for the Treatment of SARS-CoV2 (CoV) Infection

The primary objective of this study is to provide expanded access of RDV for the treatment of SARS-CoV2 infection.

Local PI: Dr Ahilanandan Dushianthan

RECOVERY-Supportive Care

Full title: Ventilation Strategies in COVID-19; CPAP, High-flow, and standard care

This trial will look at three different approaches to providing ventilatory support to patients suspected or confirmed COVID-19, all of which are currently in use in clinical practice at present;

  • High Flow Nasal Oxygen (HFNO)

  • Continuous Positive Airway Pressure (CPAP)

  • standard care involving regular oxygen therapy

We will see which is more effective in relation to survival of patients and intubation.

Local PI: Dr David Land

COVIPOC (closed)

Biofire rapid diagnostics in COVID-19.

Local PI: Dr Tristan Clark

Other COVID-19 studies at Southampton

The COVID-19 resilience project

Online survey researching the impact of COVID-19 on the NHS workforce to guide psychological support for staff.

You can participate if you are an NHS clinical member of staff, whose job role involves direct patient contact and care provision. 

Take part: is.gd/covid19_resilience_project

Find out more: sites.manchester.ac.uk/covid19-resilience-project/

Psychological impact of COVID- 19

An online questionnaire exploring the psychological impact of the coronavirus, its effect on our emotions, behaviour and wellbeing.

The aim of this survey is to better understand how the coronavirus and the impact the current lockdown is having on our day to day lifestyle. We hope to find out what is helpful for people during this time and also what may be causing some people to be affected more than others in terms of their wellbeing.

Anyone over the age of 16 with access to be able to complete this online questionnaire, which takes takes around 15 minutes to fill in, can take part.

Take part: southernhealthnhs.fra1.qualtrics.com/jfe/form/SV_6h8XB1eTTWvkspn

Understanding impacts of COVID-19 restrictions on young people

A study engaging young people in Southampton and surounding areas about their experiences and concerns under lock down measures, to identify and develop solutions that support their wellbeing, mental and physical health.

Local PI: Prof Mary Barker

Examining T cell responses in virus infection (ExCel)

A study looking at blood and tissue samples from patients who are known to have a viral infection to help us better understand how the immune system works. The purpose of this project is to improve our knowledge of how the immune system works in lung diseases.

Local PI: Dr Serena Chee

Public Health England Seroepidemiology Programme 2020 + COVID-19 Response

Ongoing study measuring prevalence of viral antibodies in the population through analysis of routine blood samples, expanding to include COVID-19.

SHARE

Full title: How to support children with cancer and their parents during the COVID-19 outbreak?: understanding experiences, information and support needs, and decision-making.

This study aims to:

  • explore experiences, information and support needs and decision-making

  • explore how these change over time as the situation with COVID-19 evolves

  • evaluate whether online intervention iHOPE to support families helps reduce anxiety and stress

 

To take part in the SHARE study survey, parents should visit https://cclg.uk/COVID-parent-survey and children and young people should visit https://cclg.uk/COVID-CYP-survey

Local PI: Dr Juliet Gray (CI: Prof Sophie-Anne Darlington)
Contact: SHARE.study@soton.ac.uk

Investigating and forecasting the impact of COVID-19 in Emergency Departments

To evaluate the impact of Covid-19 on the operations of Emergency Departments. Answering questions such as: at what times of day are the ED busiest with COVID-19 cases.

Local PI: Dr Michael Kiuber

COVID-19 Emergency Response Assessment (CERA)

The CERA study will aim to understand the evolving and cumulative effects of working during the COVID-19 outbreak on the psychological health of those physicians working in the Emergency Department during the pandemic wave of the 2020 UK outbreak.

Local PI: Dr Peter Ellis

Germ Defence

Full title: Rapid co-design, implementation and evaluation of a digital behaviour change intervention to improve hand hygiene and limit spread of the COVID-19 outbreak

Project to evaluate how the existing digital public health intervention Germ Defence can be very rapidly adapted and optimised for the changing needs of an infection outbreak, using novel participatory-co-design methods.

Local PI: Prof Lucy Yardley

COVID-PCD

Full title: COVID-19 infections in people with Primary Ciliary Dyskinesia

International longitudinal survey of COVID-19 infections in people with Primary Ciliary Dyskinesia.

Local PI: Prof Jane Lucas

COVSurf

Full title: A clinical trial of bovactant (Alveofact ®) for the Treatment of moderate to severe COVID-19

To assess improvement in oxygenation and pulmonary ventilation in patients with COVID-19 after treatment with the surfactant Alveofact ®.

Local PI: Dr Ahilanandan Dushianthan

UK Coronavirus Cancer Monitoring Project

The aims of this project are to ensure adequate cancer care is being delivered where required across the country and to assess the impact on cancer patients.

Local PI: Prof Ellen Copson

SafeFit

Full title: Virtual clinics to deliver universal interventions to maintain and improve mental and physical health in people with cancer who are following solcial distancing guidance: a COVID-19 targeted trial

Aims to investigate whether the promotion of these interventions delivered via virtual clinics in socially distanced people with cancer can improve physical and psychological function and self-efficacy to self-manage. We are also aiming to evaluate health economics.

Local PI: Prof Sandy Jack

The GOOD-Night COVID study

Full title: GOOD nasal irrigation and gargling to halt transmission of COVID-19 to care-home-based vulnerable Individuals

A cluster randomised trial of saline rinse and mouth gargle at the onset of viral upper respiratory tract symptoms in healthy participants in care home residents and care home carers.

Local PI: Dr Thomas Daniels

Pregnancy and Neonatal Outcomes in COVID-19

Aims to better understand some specific research questions as to how COVID-19 affects early pregnancy, fetal growth, prematurity and virus transmission to the baby.

Local PI: Dr Alex Kermack

Characterisation of a novel ACE-2 transcript in nasal epithelium

Characterisation of a novel ACE-2 transcript in nasal epithelium.

Local PI: Prof Jane Lucas

WRAPPED
Full title: Women's Responses to Adjustment in Product Placement and its Effects on Diet

Interviews with participants to find out about their shopping experiences during the pandemic.

Local PI: Prof Janis Baird

Neonatal Complications of Coronavirus Disease (COVID-19) Study
This study will collect information about newborn babies who have coronavirus or who are born to mothers who have coronavirus.

Local PI: Dr Mark Johnson

CovEMERALD
Full title:  Can can early Eye Movement Desensitisation and Reprocessing intervention improve psychological outcome following Covid-19 critical illness: a feasibility trial

Local PI: Dr Rebecca Cusack

REALIST
Full title: Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration (REALIST) trial: An open label dose escalation phase 1 trial followed by a randomised, double-blind, placebo-controlled phase 2 trial
The aim of this study is to conduct a phase 1 and a phase 2 clinical trial of human umbilical cord derived CD362 enriched MSCs, (REALIST ORBCEL-C cells), in patients with ARDS.

Local PI: Dr Ahilanandan Dushianthan

Monitoring skin health of clinical staff wearing PPE during COVID-19 pandemic

Monitoring skin health of clinical staff wearing PPE during COVID-19 pandemic.

Local PI: Miss Kay Mitchell

REACT
Full title: REACT observational study of COVID19A Longitudinal Cohort Study to Facilitate Better Understanding and Management of SARS-CoV-2 from admission to discharge across all levels of care

Local PI: Prof Tom Wilkinson

FALCON

Full title: Facilitating AcceLerated Clinical validation Of Novel diagnostics for COVID-19

Aims: 

(1) To determine the diagnostic accuracy of novel commercially supplied IVDs for active infection with SARS-CoV-2 

(2) To determine the accuracy of novel commercially supplied IVDs for monitoring the development of antibodies against SARS-CoV-2.

Local PI: Dr Robert Crouch

INFLAME

Full title: Identification of Novel Factors Leading to Activated Macrophage Expansion in COVID19 and related conditions to guide targeted intervention

This project aims to undertake a high-resolution analysis of previous cases of COVID19 infection to determine from all available clinical data recorded over the timeline of admission, who might benefit best from specific interventions designed to target a hyper inflammatory response in this condition.

Local PI: Dr Mike Arden-Jones

SIREN

Full title: Impact of detectable anti-SARS-COV2 on the subsequent incidence of COVID-19 in healthcare workers

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.

Local PI: Dr Eleri Wilson-Davies

PHOSP-COVID

Full title: Post-hospitalisation COVID-19 study: a national consortium to understand and improve long-term health outcomes

All patients who are admitted to UK recruiting hospital sites will be invited following discharge with clinical suspected COVID-19. Research data will be collected according to a Research Tier system:
Tier 1: Clinical data only, healthcare records, ‘left-over’ clinical samples, saliva kit for DNA
Tier 2: Extended data obtained from additional research procedures and samples.
Tier 3: Research-specific recall for additional procedures and sampling including semi-structured interviews.

Local PI: Dr Mark Jones 

CLARITY

Full title: Impact of biologic and immunomodulatory therapy on sars-cov-2 infection and immunity in patients with inflammatory bowel disease

This study will provide an evidence base for safer prescribing of immunomodulator and biologic drugs in the COVID-19 era and inform public health policy regarding physical distancing measures, and future vaccination strategies.

Local PI: Dr Fraser Cumming

SynAIRgen

Full title: A randomised, double-blind, placebo-controlled, Phase III trial to determine the efficacy and safety of inhaled SNG001 for the treatment of patients hospitalised due to moderate COVID-19

Local PI: Prof Tom Wilkinson

Pregnancy and Neonatal Outcomes in COVID-19

To better understand some specific research questions as to how COVID-19 affects early pregnancy, fetal growth, prematurity and virus transmission to the baby the researchers will construct a registry of women with suspected and confirmed COVID-19.

Local PI: Dr Alex Kermack

CHEETAH

Full title: Home ophthalmology assessment to allow for future social distancing

To determine the statistical strength and / or presence or absence of correlation between the iPAD-based visual acuity assessment procedure in comparison to clinic-based visual acuity assessment. To explore through a quantitative questionnaire the possible feasibility and utility of home-based visual acuity assessment. 

Local PI: Dr Daniel Osborne

UK Coronavirus Cancer Monitoring Project

The aims of this project are to ensure adequate cancer care is being delivered where required across the country and to assess the impact on cancer patients.

Local PI: Prof Ellen Copson

Personal Respirator Southampton (PeRSo)

Personal Resiprator Southampton (PeRSo) Personal protective equipment (PPE) to be worn by frontline NHS staff exposed to risk of COVID-19 infection, without interruption for several hours, delivering clean HEPA filtered air into a face mask.

Local PI: Prof Paul Elkington

City-wide testing project

Full title: Feasibility study for city-wide testing using saliva based LAMP testing

We will conduct a pilot project to inform a demonstration programme to examine the effectiveness of a weekly population screening programme for Covid-19 on a city-wide level to find, isolate and provide care for infected cases as needed, enabling the city’s population to lead near normal lives.

Local PI: Prof Keith Godfrey

COVID-19: exploring messaging and support for young people

To understand how the pandemic is affecting young people’s lives, their mental health and well-being and eating habits and physical activity behaviours. To develop resources to support young people maintain well-being, eat well, keep active and adhere to government guidelines during the pandemic. 3. To disseminate insights from young people to local and national government and youth organisations.

Local PI: Prof Mary Barker

ENACT-IG

Full title: Enabling New Approaches to Clinical Treatments (Information Governance)

 

This project aims to: 
• clarify the ethical and legal framework, necessary approvals and appropriate protections of privacy for a series of clinical and research use cases. 
• assess a representative public view about (a) appropriate use of their data and protections that need to be in place (b) how their consent to such uses might best be ascertained.  
• identify current changes in community perceptions around clinical data use in view of the COVID-19 pandemic.

 

Local PI: Prof Anneke Lucassen