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Research into the longer term effects of COVID-19 in non-hospitalised individuals - Call scope

 

Contents

There is now increasing medical evidence and patient testimony showing that a small but significant minority of people who contract and survive COVID-19 report chronic symptoms ranging from breathlessness, chronic fatigue, 'brain fog', anxiety and stress for months after initially falling ill.[1],[2],[3] These ongoing problems, commonly termed ‘Long COVID’, may be experienced by patients regardless of how severe their COVID-19 infection was and irrespective of whether they were hospitalised. NHS England has recently launched a plan to support ‘Long COVID’ patients in the community.

The NIHR and UK Research and Innovation (UKRI) are jointly funding major studies to characterise acute and longer term disease in hospitalised patients, for example the UK-wide ISARIC-4C and Post hospitalisation COVID-19 (PHOSP-COVID) study

The NIHR and UKRI are now launching a UK-wide further joint research call of up to £20 million to fund ambitious and comprehensive research into understanding, mitigating and addressing the longer term, physical and mental health effects, of COVID-19 in non-hospitalised individuals.

Projects are expected to start early in the New Year and may be funded for up to 3 years in the first instance.

Scope

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

Proposals are invited which address the causes (biological and environmental), mechanisms and management of the longer term physical and mental health effects of COVID-19 infection as well as reducing health inequalities in non-hospitalised individuals. In addition, proposals may wish to draw upon the learnings from other conditions/syndromes that might have some similar symptoms encountered by ‘Long COVID’ (e.g. stroke, multiple sclerosis, CFS/ME, PTSD etc.) and their management.

However, gaining a greater insight into the sequalae, their pathogenesis and/or management of ‘Long COVID’ must remain the primary objective. While the scope of the funding call is on the longer term biological and health impacts of COVID-19, proposals may also wish to capture/consider societal factors and demographic characteristics that influence these outcomes, and any downstream social and economic effects (e.g. returning to work, impacts on carers).

Example areas that the research may address include, but are not limited to:

  • Determining whether ‘Long COVID’ is a distinct syndrome or a set of syndromes
  • Identifying whether an identifiable subgroup of symptoms exists
  • Determining the prevalence of ‘LongCOVID’
    • Understanding factors that increase or diminish the risk of ‘LongCOVID’; this might include viral titre, age, gender, ethnicity, socioeconomic status or comorbidities
      • Comparison with other cohorts e.g. seasonal influenza
    • Understanding the trajectory and how people experience ‘Long COVID’ over time including any biological, social and/or ecological interactions that impact on the severity of symptoms  
  • Determining the pathogenesis of ‘Long COVID’
  • Developing and assessing the effectiveness of approaches to reduce the risk of ‘Long COVID’ and/or interventions and therapies to address its impacts.
  • Management of ‘Long COVID’ in primary care and social care settings

Funding approach

This call is looking to fund two or three ambitious and comprehensive proposals and a small number of study extensions which take a holistic approach through either:

  • extending existing studies/platform/population resources, including data linkage activities, with justification for clear added value to these established activities
  • establishing new large scale collaborative research programmes, which include other disciplines, cohorts and data sources where possible and appropriate, including those already supported by UKRI/NIHR COVID-19 funding (see a full list of jointly funded studies).

The call is not looking to fund small-scale standalone projects focusing on discrete areas.

Where possible, research platforms/cohorts should be designed in such a way that they can also support intervention assessment, either as part of original plans or in due course.

Proposals should also consider the lived experiences of those suffering with the effects of COVID-19 and include plans for patient and public involvement (PPI). This should include engagement of participants in the co-production of research questions and their delivery, with consideration of representative participation including from social care, under served and less frequently heard communities.

Please note that the Funders recognise that proposed research may be based on preliminary findings and/or require further partnership/consortium development. Proposals are recommended to consider adaptive design and/or consortium development approaches, supported by provision of risk management strategies/milestones to manage research/consortium refinement along the time course.

The Funders are however keen to see studies start as soon as possible in the New Year in order to include the current wave of COVID-19 infections.

Eligibility

Academic Principal Investigators applying for this call must be hosted by a UK institution which is eligible for UKRI funding. Applications from small and medium sized enterprises (SMEs; including start-up or ‘spin-out’ companies), government arms length bodies, and NHS organisations (including NHS Trusts and NHS Foundation Trusts), and equivalent UK authorities are also acceptable in alignment with NIHR funding policies, where these organisations are the lead applicant. An SME is defined as an organisation registered in the UK, with 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. Awards to UK-based, non-SME commercial entities will be also considered.

Specialist services or expertise may be brought into the team through consultancy or sub-contract arrangements, however, appropriate justification must be provided. Sub-contractors and collaborators (who are partners in the bid but not directly funded by it) may be based outside of the UK.

Applicants should consider whether and how international linkage could help deliver/validate research objectives. Researchers from overseas research organisations providing important local engagement and context are permissible as Co-Investigators on proposals where appropriately justified, but it is expected that the majority of efforts will be focused on and be undertaken in the UK. Other overseas researchers may be Co-Investigators, if they provide necessary expertise/access to resources not available in the UK.

Research institutes, including UKRI Units/Institutes, for which the Research Councils have established a long-term involvement as major funder are also eligible for this call.

Funding available

Up to £20m will be available for this call. The size of grants will vary according to the needs of each proposal but will need to provide a robust case for value for money.

Requested costs for UK based researchers should be 80% of full economic costs (fEC) and, where relevant, for overseas researchers should be 100% of direct costs only. Funded projects in academia will be subject to standard UKRI Ts&Cs for fEC research grants. In line with NIHR funding policy this call will cover 100% direct costs for SME and NHS trusts (across the whole of the UK).

NIHR funding for NHS Trusts and SMEs, where they are the lead applicant, will be subject to a research contract which sets out a revenue sharing approach (see an example contract for NHS trusts and an example contract for SMEs). Contractual terms for awards provided to UK-based, non-SME commercial entities will be agreed on a case-by-case basis between NIHR and the applicant. 

There are no set rules on the split between collaborators, however, as the contracted organisation, the lead applicant will receive funding payments and would be required to distribute to co-applicants/contractors where applicable. Awards issued to NHS organisations through this initiative will be eligible for Research Capability Funding.

How to apply

Applicants must submit an online application via the NIHR Central Commissioning Facility Research Management System. To assist the funders in preparing for peer review research teams should submit an Expression of Interest (EoI) by 02 December by emailing it to: ccf-ncov@nihr.ac.uk. EoIs should be not more than 2 sides of A4 and should be top level and provide the underlying objectives and identify lead and key partners.

A Word version of the online form is available 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 CCF RMS will be accepted, however information can be copied from the Word template into the online application form.

Please note that successful applicants will be required to return their award acceptance within five working days of receipt, together with an invoice, from their Administering Authority. Failure to comply with these requirements could result in forfeiture of the award.

Evaluation process

Proposals will be reviewed firstly by the UKRI/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 an Expert Funding Committee, who will make recommendations on outcome to UKRI and DHSC. Applicants will not have an opportunity to respond to Panel 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 submissions will include:

  • The potential for the proposal to have an impact within the period of the award and to provide a unique value-added research against the call scope and a contribution relative to existing activity  
  • Access to required resources
  • Applicant expertise and experience
  • Partnership: including strength and clarity of collaborations and opportunities provided
  • 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 institution/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.

Key call dates

Stage

Date

Call launch

12 November 2020

Expression of Interest (EoI) submissions

02 December 2020

Call close

09 December 2020

Notification of outcome and project start

End of January 2021

 

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.

Other Information

The information collected throughout the application and assessment process will be used to support the peer review process and inform our funding decisions, for the management and monitoring of awards, and the evaluation of the funding programme.

Proposal information is treated confidentially and in line with our privacy notice, UKRI fEC Grants Terms and Conditions and our guidance on the Use of Grant Proposal and Training Grant Information. Information relating to proposals may be shared, on a confidential basis, across DHSC/NIHR and UKRI councils, and with other organisations to support the national and international coordination of research to combat COVID-19 and to seek funding contributions from third parties.

References

[1] Tony Blair Institute for Global Change. Long Covid: Reviewing the Science and Assessing the Risk. 5 October 2020.

[2] NIHR Evidence. Living with COVID-19. Themed review, 15 October 2020.

[3] Royal Society. Urgent need for more research to understand Long Covid. 28 October 2020.