Long COVID call 2021 - Call specification

Key Features

• Focus of call is on helping and supporting non-hospitalised individuals with Long COVID
• Proposals on Therapies and Interventions, Management and Evaluation of Services, and Diagnostics particularly welcome, but other topics also eligible.
• Projects can be up to 24 months in duration, but shorter proposals are encouraged, and are expected to be designed to deliver rapid tangible outcomes 
• The deadline is 1pm 12 May 2021 (with EoI forms to be submitted by 1pm 05 May).

Background

While many people will make a full recovery following COVID-19 there is clear evidence that a significant proportion of individuals will continue to experience chronic symptoms.  These symptoms, or symptom clusters, are wide ranging lasting for months. These ongoing problems, commonly termed ‘Long COVID’, may be experienced by individuals regardless of how severe their COVID-19 infection was and irrespective of whether they were hospitalised.  

The NIHR and UKRI supported four research projects, via a joint funding call launched in November 2020, which will provide an evidence base to underpin the understanding of Long COVID.  The NIHR is now launching a subsequent UK-wide £20m funding call which is focussed on funding research which will help and support non-hospitalised individuals with Long COVID.

Scope

The call specification draws on recent publications and following advice from a specially-convened external Expert Group.

Proposals must focus on helping and supporting individuals, both adults and children, with Long COVID. Proposals should be distinct from research funded in NIHR's previous Long COVID call with UKRI and other calls, including the project UK evaluation of NHS support post-hospitalisation for COVID-19.  Applicants should clearly state how their proposed research addresses an explicit evidence gap and how the research adds value to the existing NIHR research portfolio. While this call is open to proposals on Long COVID, there are specific topics the NIHR wishes to address as a priority.

Individuals living with Long COVID are central to this call and as such patient and public involvement (PPI) is critical.  This should include engagement of participants in the co-production of research questions and their delivery, with consideration of representative participation including from under-served communities.

The specific topics of interest are listed below with example areas that proposals may wish to address.  Please note that the examples are not exhaustive lists and other areas will be considered.

This call is aiming to fund a range of proposals including stand-alone projects addressing specific topics but also larger collaborations which take a wider approach to a range of topics.

Therapies and Interventions

It is acknowledged that currently the understanding of the nature of Long COVID means it is challenging to identify potentially useful pharmaceutical interventions for research.  However, various drugs are currently being used to treat Long COVID patients and evidence is needed to understand how and whether these are effective.

Proposals which assess the effectiveness and cost effectiveness of interventions for improving outcomes for individuals with Long COVID. This could include a range of pharmaceutical and non-pharmaceutical therapies addressing physical and/or psychological aspects, including how they interact, and should include practical outcomes which focus on individuals e.g. return to work.  Specific examples could include:

• Rigorous assessments of interventions and therapies particularly those which are currently being used in practice or which could be repurposed.
• Assessment of movement therapy, nutritional approaches, and vitamin supplementation to help manage Long COVID.  Where appropriate, these approaches should be individualised and take into account subsets of Long COVID individuals and use appropriate objective measures.
• Evaluation of the COVID-19 vaccine programme on the impact of Long COVID, both at individual and population level.
• An approach to prioritising potential therapeutic candidates.
• Development of Core Outcome Sets (COS) of measures to be used in future trials.
• Assessment of rehabilitation programmes including both physical and psychological support.  This could include multidisciplinary team rehabilitation interventions.
• Assessment of interventions and therapies which may slow or prevent the onset/development of Long COVID.

Management and Evaluation of Services

Proposals which evaluate or provide evidence of the most effective and cost effective pathways and service management approaches, including healthcare, community and social care services.  Specific examples could include:

• Evaluation of existing and new health and care services/pathways, including remote delivery, to increase better outcomes for those with Long COVID.
• Natural experiment opportunities between different service configuration across England and between the four UK nations.
• Assessment of access to services, especially for vulnerable and under-served groups, including examining communication between clinicians and patients and its effect on access and uptake of services.
• Understanding more about how patients are living with and managing symptoms at home, in the community and in health/care services.
• Examining approaches to workforce skills in relation to how and where services are or should be delivered.
• Assessment and management of any potential deterioration of symptoms including the factors which may affect outcomes, for both adults and children.

Diagnostics

• Assessment of proportional diagnostics including what is the appropriate range and repetition of tests leading to appropriate and cost-effective outcomes.
• Different approaches, including Bayesian approach, to understand the usefulness of various diagnostic tests and how these link to actual outcomes.

General principles

In addition to the above topics and questions, proposals should consider the following, where appropriate:

• Proposals are encouraged to address the variety of settings that individuals with Long COVID may be in such as primary care, secondary care, social care, community care, care homes, domestic settings, and specialised services.
• Proposals should consider the range of workforce staff and carers who are or could support the management of Long COVID, including GPs, community nurses, physiotherapists, occupational therapists, social care workforce, unpaid carers, parents as carers, patient/peer support groups etc.
• Proposals should include appropriate and practical outcomes which focus on individuals and could include quality of life, daily activities, return to work, educational attainment etc.
• The use of existing cohorts could be appropriate but generating new cohorts is also encouraged.
• Inclusion of under-served and seldom heard groups including vulnerable groups, those with complex needs, Black, Asian and Minority Ethnic (BAME) communities, prison populations etc as well as consideration of wider inequalities and socioeconomic factors.
• Where appropriate, learning and understanding from other conditions which may have some similar symptoms is encouraged e.g. Chronic fatigue syndrome (CFS)/Myalgic encephalomyelitis (ME), other Post-viral syndromes etc.
• Innovative and efficient designs which lead to swift outcomes are welcome.

Eligibility

Principal Investigators hosted at an eligible UK organisation is eligible to apply.  This includes universities, NHS organisations (including NHS Trusts and NHS Foundation Trusts), Small and Medium Enterprises [1] (including start-up or ‘spin-out’ companies), government arms length bodies, and equivalent UK authorities are also acceptable in alignment with NIHR funding policies.  Awards to UK-based, non-SME commercial entities will also be considered.  Specialist services or expertise may be brought into the team through consultancy or sub-contract arrangements, however, appropriate justification must be provided. The involvement of international collaborators is permitted where appropriate justification is provided.

How to Apply

Applicants must submit an online application via the PMO RMS.  To assist the funders in preparing for peer review research teams should submit an Expression of Interest (EoI) by 1pm on 05 May.  

A Word version of the online application form will be made available at call launch and can be used to assist research teams developing an application.  Please note the Word form cannot be submitted as an application. Only applications submitted online via the PMO RMS will be accepted, however information can be copied from the Word template into the online application form.

Key call dates

Evaluation process

Proposals will be reviewed firstly by the NIHR office for fit to scope and eligibility.  Eligible applications within scope of the call will then be reviewed by external peer reviewers.  These reviews will then be used by a Funding Committee, potentially with a triage process, who will make recommendations on outcomes to NIHR. Applicants will not have an opportunity to respond to Committee comments in instances where feedback is provided, except where clarifications and/or changes are required as part of the award process.

Key assessment criteria for the proposals will include:

• The potential for the proposal to have an impact on helping and supporting individuals with Long COVID and the timeframe in which this will occur
• How the proposal provides unique value-added research against the call scope and a contribution relative to existing activity    
• Meaningful involvement of patients, carers and the public throughout the lifecycle of the research from proposal development, design to delivery and dissemination of the research
• Access to required resources
• Applicant expertise and experience
• Design and feasibility of project plan
• Quality and appropriateness of the project management structure
• Governance arrangements
• Value for money.

The decisions of the Committee will not be open to appeal and the funders reserve the right to amend the application process.

Ethics and governance

The funders do not require ethics permissions and regulatory approvals to be in place when an application is submitted. If an application is successful, it is the responsibility of the host organisation/company to ensure that the appropriate ethics approval(s) has been obtained and that no research requiring such approval is initiated before it has been granted.

Contact information

For general and scientific queries relating to the call, including queries relating to the administrative process of applying, please contact ccf-nCoV@nihr.ac.uk.

References

[1] SME is defined as registered in the UK, have a staff headcount no greater than 250 and annual turnover no greater than €50 million (including start-up or spin-out companies). Companies must be registered on Companies House prior to being eligible for funding.