# Clinical platform trials for coronavirus (COVID-19) treatments

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/f78811fd-e006-4075-bdd0-6ec3905fb657
Type: Detailed Guide
Published: September 6, 2022
Updated: March 31, 2023

> The COVID-19 Antivirals and Therapeutics Taskforce, a joint initiative by the UK Department of Health and Social Care (DHSC) and the National Institute for Health and Care Research (NIHR), officially concluded its operations on March 31, 2023. This closure marks a shift toward the government’s long-term strategy of managing COVID-19 through integrated clinical research rather than emergency taskforce oversight. Under a regulatory framework facilitated by the Medicines and Healthcare products Regulatory Agency (MHRA), the taskforce established a UK-wide process to prioritize Urgent Public Health research. This infrastructure supported several major trial platforms, including RECOVERY, REMAP-CAP, and PANORAMIC, which successfully identified life-saving treatments such as dexamethasone and tocilizumab. Conversely, the trials provided critical evidence to discontinue the use of ineffective treatments like hydroxychloroquine and aspirin. Following the taskforce's dissolution, the DHSC continues to support clinical platforms across all trial phases to evaluate new therapeutic candidates. Required actions for research organizations include submitting proposals for promising treatments via the MHRA’s established clinical trial application guidance. Patients seeking to participate in ongoing research, such as the HEAL-COVID or STIMULATE-ICP trials for long-term recovery, are directed to the NIHR’s digital research portal for eligibility and enrollment information.

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Closure of the COVID-19 Antivirals and Therapeutics Taskforce on 31 March 2023 In line with the government’s strategy of living with COVID-19 , the COVID-19 Antivirals and Therapeutics Taskforce closed on 31 March 2023. Find out more about available COVID clinical research on the National Institute for Health and Care Research ( NIHR ) website. Find out more about COVID-19 treatments on the NHS website. About clinical trials Clinical trials are essential to finding new and improved methods of treating different diseases including coronavirus (COVID-19). Clinical trials allow us to understand whether new treatments: genuinely improve recovery and survival for patients who contract COVID-19 should be made available more widely in the NHS Phase 1 and 2 trials Phase 1 and 2 trials are early-stage trials involving small numbers of participants to ensure a treatment is safe to use and shows evidence of a benefit beyond the standard of care. Treatments that are found to be safe at this stage may then proceed to be tested in a phase 3 clinical trial. Phase 3 trials Phase 3 trials involve large numbers of patients and assess whether a treatment is effective enough to be used more widely in the NHS . Clinical platform trials for COVID-19 treatments in the UK The National Institute for Health and Care Research ( NIHR ) established a single UK -wide process to prioritise COVID-19 research as Urgent Public Health research early in the COVID-19 pandemic. The purpose was to: prevent duplication of effort ensure the UK is running large enough trials to get definitive answers to key questions The COVID-19 Antivirals and Therapeutics Taskforce worked with NIHR and other partners to horizon scan and monitor national and international developments in COVID-19 antivirals and therapeutics. The Department of Health and Social Care ( DHSC ) is continuing to support a series of national clinical trial ‘platforms’ across all phases of human trials and in a range of patient cohorts. These are assessing several therapeutic and prophylactic candidates, and are supported by the NIHR Clinical Research Network across the UK to identify and enrol patients. The trial platforms are co-ordinated in a streamlined manner so that treatments can move through phase 1, 2 and 3 trials. This provides a clear route for treatments to progress rapidly from small to large-scale trials to prove safety and efficacy in treating COVID-19. Individuals from research organisations can make proposals for promising COVID-19 treatments to be considered for addition to any of the UK clinical trial platforms. See the Medicines and Healthcare products Regulatory Agency’s guidance on clinical trials applications for coronavirus (COVID-19) . Each of the clinical trial platforms is assessing a range of potential COVID-19 treatments. Further information can be found on the individual trial websites. AGILE AGILE is a phase 1 and 2 clinical trial that aims to identify the safe dosage for new COVID-19 treatments, and determine whether each treatment shows evidence of a benefit beyond the standard NHS care in small patient numbers. RECOVERY The RECOVERY trial is the world’s largest randomised controlled clinical trial for COVID-19 treatments, having recruited over 39,000 participants in its first year of running. Participants in this trial are patients who have been admitted to hospital with moderate to severe COVID-19. Treatments that are found to be effective in RECOVERY will be made available in the NHS to treat those with severe COVID-19 in hospital. RECOVERY+ The RECOVERY+ trial is an extension of the larger phase 3 trial platform RECOVERY . RECOVERY+ is a phase 2 trial testing promising COVID-19 treatments for hospitalised patients. Treatments that are successful in phase 2 trials as part of RECOVERY+ will be rapidly considered for addition to the phase 3 trials in RECOVERY to prove safety and efficacy in large patient numbers. REMAP-CAP REMAP-CAP is an international phase 3 trial testing treatments in patients with severe COVID-19 infection in intensive care units. Treatments that are found to be effective in REMAP-CAP will be made available in the NHS to reduce mortality and accelerate recovery in COVID-19 patients. PRINCIPLE PRINCIPLE is a phase 3 trial testing treatments in the community. The PRINCIPLE trial is investigating treatments that could prevent mild COVID-19 infection from becoming more serious, and participants in this trial are COVID-19 patients who have not been admitted to hospital. If a treatment is found to be effective in PRINCIPLE, it will be made available in NHS primary care to improve health outcomes and reduce the number of patients who need to be admitted to hospital. PROTECT-V PROTECT-V is a phase 3 trial testing prophylactic interventions for COVID-19 in vulnerable renal and immunocompromised patients. It aims to test their effectiveness at reducing infections at events such as regular hospital check-ups or dialysis appointments. Any treatment found to be effective as part of this platform will improve COVID-19 treatment for this vulnerable cohort of the population. HEAL-COVID HEAL-COVID is a phase 3 trial testing potential treatments to determine whether they can improve the longer-term outcomes for patients who have been discharged from hospital after recovering from COVID-19. This is part of the DHSC ’s effort to not only ensure that patients survive but return to full health post-COVID. STIMULATE-ICP STIMULATE-ICP (symptoms, trajectory, inequalities and management: understanding long COVID to address and transform existing integrated care pathways) is a phase 3 trial that is currently being set up at University College London Hospitals NHS Trust. It will be the largest long COVID trial to date, recruiting more than 4,500 people with the condition. It will test the effectiveness of existing drugs to treat long COVID by measuring the effects of 3 months’ treatment, including on people’s symptoms, mental health and outcomes such as returning to work. It will also assess the use of MRI scans to help diagnose potential organ damage, as well as enhanced rehabilitation through an app to track their symptoms. PANORAMIC PANORAMIC is a UK -wide study sponsored by the University of Oxford and funded by the NIHR to find out in which people new community-based antiviral treatments for COVID-19 reduce the need for hospital admission and improve outcomes. How to take part in a clinical trial Find out if you’re eligible to take part in a clinical trial on the NIHR ’s Be Part of Research website . There were a number of ground-breaking clinical trial results obtained through our national clinical trials infrastructure during the pandemic. These ensured that UK patients were able to access treatments as soon as they became available. Results of trials to date: effective and ineffective treatments In June 2020, the RECOVERY trial identified dexamethasone as the world’s first effective treatment for COVID-19 . Since then, there have been positive findings on tocilizumab from the REMAP-CAP and RECOVERY trials . Effective treatments Table 1: summary of treatments that have been found to be effective in treating COVID-19, as part of the UK clinical trial platforms Date Treatment Trial Patient cohort Further guidance 6 October 2022 Molnupiravir PANORAMIC Non-hospitalised patients Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes (PANORAMIC): preliminary analysis 3 March 2022 Baricitinib NIHR press release: RECOVERY trial shows baricitinib reduces deaths in COVID-19 hospitalised patients RECOVERY Hospitalised patients RECOVERY trial press release: New RECOVERY trial result – baricitinib reduces deaths in patients hospitalised with COVID-19 17 September 2021 Ronapreve DHSC press release: Thousands of patients to benefit from life-saving COVID-19 treatment RECOVERY Hospitalised patients who have not mounted an antibody response against COVID-19 16 June 2021 REGEN-COV RECOVERY Hospitalised patients with severe COVID-19 who are seronegative (that is, have not mounted a natural antibody response) RECOVERY trial press release: RECOVERY trial finds Regeneron’s monoclonal antibody combination reduces deaths for hospitalised COVID-19 patients who have not mounted their own immune response 12 April 2021 Inhaled budesonide PRINCIPLE press release: asthma drug budesonide shortens recovery time in non-hospitalised patients with COVID-19 PRINCIPLE COVID-19 patients in the community who are 65 and over or 50 and over with an underlying health condition COVID-19 therapeutic alert for inhaled budesonide 11 February 2021 Tocilizumab NIHR press release: RECOVERY trial shows tocilizumab reduces deaths in patients hospitalised with COVID-19 RECOVERY Tocilizumab results press release Hospitalised patients who are receiving oxygen and are hypoxic DHSC press release: Thousands more NHS patients to get life-saving COVID-19 treatment 7 January 2021 Tocilizumab and sarilumab NIHR press release: arthritis drugs effective in improving survival in sickest COVID-19 patients REMAP-CAP Press release: reduced mortality for sickest COVID-19 patients Patients in intensive care DHSC press release: NHS patients to receive life-saving COVID-19 treatments that could cut hospital time by 10 days COVID-19 therapeutics alert for IL6 inhibitors 16 June 2020 Dexamethasone NIHR press release: first drug to reduce mortality in hospitalised patients with respiratory complications of COVID-19 found RECOVERY Dexamethasone results press release Hospitalised patients requiring oxygen or ventilator support DHSC press release: world-first coronavirus treatment approved for NHS use by government COVID-19 therapeutic alert for corticosteroids NICE prescribing briefing WHO guidance on corticosteroids Ineffective treatments Robust clinical trials are critical to building an evidence base of what does and does not work. It is of equal importance to reach conclusions on the ineffectiveness of potential COVID-19 treatments in order to deliver the best possible care to patients. Table 2: summary of treatments that have been found to be ineffective in treating COVID-19, as part of the UK clinical trial platforms Date Treatment Trial Patient cohort 22 November 2022 Apixaban HEAL-COVID Blood thinning drug to treat recovery from severe COVID-19 is not effective Hospitalised patients 8 June 2021 Aspirin RECOVERY RECOVERY trial finds aspirin does not improve survival for patients hospitalised with COVID-19 Hospitalised patients 5 March 2021 Colchicine RECOVERY RECOVERY trial closes recruitment to colchicine treatment for patients hospitalised with COVID-19 Hospitalised patients 25 January 2021 Doxycycline NIHR press release: PRINCIPLE trial finds no benefit from antibiotics, azithromycin and doxycycline for COVID-19 patients PRINCIPLE PRINCIPLE trial finds antibiotics azithromycin and doxycycline not generally effective treatments for COVID-19 Patients aged over 65 (or over 50 with an underlying health condition) in the community 25 January 2021 Azithromycin NIHR press release: PRINCIPLE trial finds no benefit from antibiotics, azithromycin and doxycycline for COVID-19 patients PRINCIPLE University of Oxford press release: PRINCIPLE trial finds antibiotics azithromycin and doxycycline not generally effective treatments for COVID-19 Patients aged over 65 (or over 50 with an underlying health condition) in the community 15 January 2021 Convalescent plasma RECOVERY+ Convalescent plasma results press release Hospitalised patients 11 January 2021 Convalescent plasma NIHR press release: studies find no evidence of convalescent plasma benefit for hospitalised COVID-19 patients REMAP-CAP Press release: international trial of SARS-CoV-2 convalescent plasma pauses enrolment of critically ill COVID-19 patients Patients in intensive care units 22 December 2020 Heparin REMAP-CAP Severely ill patients in intensive care units requiring oxygen support 14 December 2020 Azithromycin NIHR press release: RECOVERY trial shows no clinical benefit from azithromycin for hospitalised patients RECOVERY Azithromycin results press release Hospitalised patients 29 June 2020 Lopinavir/ritonavir RECOVERY Lopinavir-ritonavir results press release Hospitalised patients 5 June 2020 Hydroxychloroquine RECOVERY Hydroxychloroquine results press release Hospitalised patients Further information Funded research into COVID-19 ( NIHR )