Clinical trials are the gold standard when evaluating the potential of a novel treatment. A standard that should not be compromised during a pandemic. However undertaking clinical studies during a pandemic is challenging, as we need to understand how many people will be infected and where these infections will take place. The situation is made more complex by the fact that COVID-19 is a novel disease. There is limited understanding of the natural history of the disease, which makes it difficult to choose how effectiveness of a treatment should be assessed.
We are working closely with clinical experts, to utilise efficient (adaptive) trial designs to evaluate possible treatment options for COVID-19. Key to our work is having the opportunity to dismiss insufficiently promising treatments quickly, and at the same time, allow early decisions about positive effects to be made early as well. We are also exploring multiple treatments within one trial.
The three main trials we are involved in are:
A national clinical trial which aims to identify treatments that may be beneficial for people hospitalised with suspected or confirmed COVID-19.
A new clinical trial platform that has been launched specifically to test new COVID-19 treatments, faster than ever before.
A large “platform” trial that will test several treatments intended to reduce the spread of COVID-19 within care homes, and reduce the risks of hospitalisation and death. A trial platform allows multiple treatments to be tested in parallel with results analysed regularly.
This platform aims to identify treatments that may be beneficial for people discharged from hospital after recovering from COVID-19 (Long-COVID).
Find out more:
- Podcast: NIHR Podcast with Thomas Jaki on the AGILE initiative and the advantages and challenges of Platform Trials
- The AGILE Clinical Trial Platform
- Randomised Evaluation of COVID-19 Therapy (RECOVERY Trial)
Full Publications List
N Engl J Med. 2020 May 7;382(19):1787-1799. doi: 10.1056/NEJMoa2001282. Epub 2020 Mar 18. PMID: 32187464
Cunniffe NG et al. How achievable are COVID-19 clinical trial recruitment targets? A UK observational cohort study and trials registry analysis. BMJ Open. 2020. 10:e044566. PMID:33020111
Clin Trials. 2020 Oct;17(5):472-482. Epub 2020 Jul 16. PMID: 32674594
Ewings S et al. Practical recommendations for implementing a Bayesian adaptive phase I design during a pandemic. BMC Medical Research Methodology. 2022 Jan. https://doi.org/10.1186/s12874-022-01512-0
Trials. 2020 Jun 19;21(1):544. PMID: 32560744
Griffiths GO et al. AGILE: a seamless phase I/IIa platform for the rapid evaluation of candidates for COVID-19 treatment: an update to the structured summary of a study protocol for a randomised platform trial letter. Trials. 2021; 22: 487. PMID: 34311777
Khoo S et al. Optimal dose and safety of molnupiravir in patients with early SARS-CoV-2: a Phase I, open-label, dose-escalating, randomized controlled study. J Antimicrob Chemother. 2021 Nov 12;76(12):3286-3295. PMID: 34450619
Machiwenyika JMT et al. Trajectories of vital signs in patients with Covid-19. Resuscitation. 2021 May;162:449-450. PMID: 33609606
. 2021 Dec;9(12):1419-1426. PMID: 34672950Colchicine in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet Respir Med
RECOVERY Collaborative Group. Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial. Lancet. 2021 May 29;397(10289):2049-2059. PMID: 34000257
RECOVERY Collaborative Group. Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet. 2021 May 1;397(10285):1637-1645. PMID: 33933206
RECOVERY Collaborative Group. Azithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet. 2021 Feb 13;397(10274):605-612. PMID: 33545096
RECOVERY Collaborative Group. Dexamethasone in Hospitalized Patients with Covid-19. N Eng J Med. 2021 Feb 25;384(8):693-704. PMID: 32678530
N Engl J Med. 2020 Oct 8. PMID: 33031652Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19.
Lancet. 2020 Oct 5:S0140-6736(20)32013-4. PMID: 33031764
Walker et al. An Open Label, Adaptive, Phase 1 Trial of High-Dose Oral Nitazoxanide in Healthy Volunteers: An Antiviral Candidate for SARS-CoV-2. Clin Pharmacol Ther. 2021 Oct 26;10.1002/cpt.2463. PMID: 34699618
Trials. 2020 May 24;21(1):422. PMID: 32448345
Lancet. 2020 May 16;395(10236):1569-1578. Epub 2020 Apr 29. PMID: 32423584
BMJ Open. 2020 Nov 5;10(11):e043634. PMID: 33154065et al. Ensuring that COVID-19 research is inclusive: guidance from the NIHR INCLUDE project.