Open studies

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

Summary: Overview

All patients who are admitted to UK recruiting hospital sites will be invited to join the study following discharge from hospital with clinician suspected COVID-19.

Research data will be collected according to a Research Tier system to enable collection of data and samples to be tailored according to centre capacity and specific research questions to be addressed (Figure 1 and Figure 3):

Tier 1: Clinical data only, healthcare records, ‘left-over’ clinical samples, saliva kit for DNA if no follow-up clinic visit within 6 months
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. Recruitment to external research studies requiring additional consent.

The clinical pathway in Figure 1 describes a clinical framework nationally, but we envisage at least 10 centres (Appendix 2 Pg40) will provide enhanced clinical data capture to enable a more comprehensive clinical cohort. See Table 1 for example of the core and individualised data to be captured clinically and for Tier 2 research. For the latter, this could involve a research visit at 3 months and 1 year. Where patients are discharged from clinical follow up at 3 months, we have embedded a research visit at one year.

Full title: HElping Alleviate the Longer-term consequences of COVID-19(HEAL-COVID): a national platform trial

Summary: COVID-19 is the disease caused by SARS-CoV-2. Despite unprecedented public health measures, SARS-CoV-2 has rapidly spread across the world. Though much is now known about the virus and the short-term effects of the disease it causes; the longer-term complications associated with COVID-19 are only starting to become apparent. We do not yet have full information on longer-term outlook from COVID-19, but as many as 1 in 4 survivors still experience significant symptoms some weeks after the initial illness and 1 in 10 die within the first 3 months. This study will assess several different treatments that may be of benefit in reducing or preventing the complications that patients with COVID-19 are reporting after their acute illness.

HEAL-COVID is a large platform clinical trial designed to assess whether several different treatments are better than the current “standard of care” (the best available evidence-based treatment). In practice, this means the study will be flexible enough to include new treatments not specified at the start of the trial as our understanding of COVID-19 changes.

Participants will be recruited from hospitals in the UK. Adults, with SARS-COV-2 infection associated disease, hospitalised with an expected hospital discharge within 5 days will be eligible to participate in the study. Participants will be randomly assigned to one of the study treatments or standard of care and will be followed up for 12 months. Information will be collected from their routinely collected health records (mortality and subsequent hospitalisations) to minimise the burden on study participants, alongside collection of remotely entered patient reported data (online portal or smartphone app) and quality of life assessments.

The trial is funded by the National Institute of Health Research (NIHR).

Full title: Clinical Characterisation Protocol for Severe Emerging Infection

Summary: Infectious disease is the single biggest cause of death worldwide. New infectious agents, such as the SARS, MERS and other novel coronavirus, novel influenza viruses, viruses causing viral haemorrhagic fever (e.g. Ebola), and viruses that affect the central nervous system (CNS) such as TBEV require investigation to understand pathogen biology and pathogenesis in the host. Even for known infections, resistance to antimicrobial therapies is widespread, and treatments to control potentially deleterious host responses are lacking. In order to develop a mechanistic understanding of disease processes, such that risk factors for severe illness can be identified and treatments can be developed, it is necessary to understand pathogen characteristics associated with virulence, the replication dynamics and in-host evolution of the pathogen, the dynamics of the host response, the pharmacology of antimicrobial or host-directed therapies, the transmission dynamics, and factors underlying individual susceptibility. The work proposed here may require sampling that will not immediately benefit the participants. It may also require analysis of the host genome, which may reveal other information about disease susceptibility or other aspects of health status. This study, while not a study of a medicine, may involve additional procedures (some minimally invasive), the retention of genetic material, collection of personal data and additional follow up. The ISARIC consortium is keen that this protocol serve as a generic template for adoption of this study in other countries and similar studies in the future. ISARIC also intend that this protocol and supporting documents can be used to support or run alongside future intervention studies. For these reasons we aim to fulfil the standards of consent required by Medicines for Human Use (Clinical Trials) Regulations 2004 and NHS NPSA NRES Guidance for Researchers & Reviewers (May 2009). This protocol as now amended is designed to enrol patients with proven infection by Influenza A/H5N1, A/H7N9, MERS-CoV, SARS-CoV-2, viral haemorrhagic fever, TBEV, any infection on the PHE/DHSC high consequence infection list (see PHE website), and any other pathogen of public health interest as yet unspecified.

Full title: Randomised Evaluation of COVID-19 Therapy (RECOVERY)

Summary:

Background: In early 2020, as this protocol was being developed, there were no approved treatments for COVID-19, a disease induced by the novel coronavirus SARS-CoV-2 that emerged in China in late 2019.

A range of potential treatments have been suggested for COVID-19 but nobody knows if any of them will turn out to be more effective in helping people recover than the usual standard of hospital care which all patients will receive. The RECOVERY Trial will begin by testing some of these suggested treatments.

Studies in follow up

Closed to recruitment – in follow up.

The EMBARC European Bronchiectasis Registry.