COVID-19 is a community acquired pneumonia caused by infection with a novel coronavirus, SARS
CoV2 and is a serious condition with high mortality in hospitalised patients, for which there
is no currently approved treatment other than supportive care. Urgent investigation of
potential treatments for this condition is required.
This protocol describes an overarching and adaptive trial designed to provide safety,
pharmacokinetic (PK)/ pharmacodynamic (PD) information and exploratory biological surrogates
of efficacy which may support further development and deployment of candidate therapies in
larger scale trials of COVID-19 positive patients receiving normal standard of care.
Given the spectrum of clinical disease, community based infected patients or hospitalised
patients can be included. Products requiring parenteral administration will only be
investigated in hospitalised patients. Patients will be divided into cohorts, a) community b)
hospitalised patients with new changes on a chest x-ray (CXR) or a computed tomography (CT)
scan or requiring supplemental oxygen and c) hospitalised requiring assisted ventilation.
Participants may be recruited from all three of these cohorts, depending on the experimental
therapy, its route of administration and mechanism of action. The relevant cohort(s) for any
given therapy will be detailed in the therapy-specific appendix.
Candidate therapies can be added to the protocol and previous candidates removed from further
investigation as evidence emerges. The trial will be monitored by an independent Data
Monitoring Committee (DMC) to ensure patient safety.
Each candidate cohort will include a small cohort of patients randomised to candidate therapy
or existing standard of care management dependent on disease stage at entry. Cohort numbers
will be defined in the protocol appendices.
This is a Phase IIa experimental medicine trial and as such formal sample size calculations
are not appropriate.