This study will assess the efficacy of existing drugs (already authorised to treat other indications) in the treatment of COVID-19. This study aims to gather safety, pharmacokinetic (PK)/ pharmacodynamic (PD) information and exploratory biological surrogates of efficacy in small numbers of COVID-19-positive patients. Data from this study may support further development and larger scale trials of these therapies in COVID-19 positive patients receiving normal standard of care.
Due to the spectrum of disease severity, this study includes both community-based and hospitalised COVID-19 positive patients.
At present the study is assessing the efficacy of two candidate therapies:
- Nafamostat: an antiviral currently used to prevent blood clotting. It is hypothesised that it may confer benefit in COVID-19 patients via reduction in inflammation, decreasing defects in blood clotting, and blocking the mechanism by which SARS-CoV-2 gains entry to host cells.
- TD139: an inhibitor of Galectin-3 that has previously been tested in patients with idiopathic lung fibrosis, a disease associated with inflammation and lung scarring. These studies showed reduced inflammation associated with TD139 treatment. This may prove clinically beneficial in COVID-19 patient.
Candidate therapies may be added to the protocol and previous candidates removed from further investigation as evidence emerges.
More detail on the DEFINE study can be found here:
This study will assess the efficacy of the drug Camostat, currently approved in Japan for the treatment of pancreatitis and oesophagitis, two diseases characterised by inflammation. When used in vitro the drug was able to block the entry of SARS-CoV-2 into host cells. This study will assess the drug’s efficacy in COVID-19 positive patients in the community. It is hypothesised that treatment with Camostat will reduce the progression of disease and lead to a reduction in hospital admissions due to COVID-19.
More details about this study can be found here:
Building on the STOPCOVID platform, the THT team have collaborated with colleagues in the Maulana Azad Medical College (MAMC – India’s largest COVID-19 hospital) to initiate a Phase II study in Delhi, trialling low dose spironolactone and dexamethasone. This study will recruit 120 patients and is now completed.