Phase IIa randomised placebo-controlled trial cross over design of GB-0669 therapy in patients with hematologic malignancy, B-cell depletion and symptomatic or asymptomatic SARS-CoV2 infection

In late 2019 a novel coronavirus-induced disease (COVID-19) emerged in humans in Wuhan, China (SARS-CoV-2) which is now a pandemic. Of those who are admitted to hospital most get better, but some may need oxygen or mechanical ventilation before they do so, and a small number do not get better and die. The virus is highly contagious and is causing an enormous strain on NHS resources. There are currently no approved drugs to treat COVID-19. There are currently late phase platform trials looking at repurposing existing drugs (e.g. RECOVERY) but there are a lack of trials investigating new treatments.\n\nThe AGILE-ACCORD phase 1/2 platform master protocol allows incorporation of new potential treatments (candidates) that either only have laboratory data or limited patient data to indicate they may work to treat COVID-19. This early phase platform will look closely at dose, safety and evidence that they work before entering these other large phase trials.\n\nCandidates will be added into the trial (at varying times) via candidate-specific trial protocols of a master protocol. Patients will be randomised between candidate and control with 2:1 allocation in favour of the candidate. Each dose will be assessed for safety sequentially in cohorts of 6 patients, with more patients receiving the optimal dose to assess efficacy and safety. The patient population for this trial is adult patients (?18 years) who have laboratory-confirmed infection with SARS-CoV-2. It will include both severe and mild-moderate patients. Each candidate-specific trials are expected to recruit ~40 patients.