A new international trial to assess whether high doses of the antiparasitic drug nitazoxanide could help treat patients with COVID-19 has begun in South Africa.
Researchers at the University of Liverpool and Liverpool School of Tropical Medicine (LSTM) are leading the trial as part of the ground-breaking COVID-19 drug testing platform, AGILE.
The trial will be coordinated by the Global Health Trials Unit and LSTM. AGILE’s partners for the study in South Africa are the Desmond Tutu Health Foundation at the University of Cape Town and Ezintsha at the University of the Witwatersrand.
To tackle the COVID-19 pandemic, there is an urgent need for therapeutic interventions to compliment global vaccination programmes. The repurposing of existing drugs is a key strategy in this search as it involves less time and cost than developing new ones. Likewise, resulting therapeutic regimens could be rapidly made accessible in low and middle-income countries.
Dr Catherine Orrell, Principal Investigator at the Desmond Tutu Health Foundation, University of Cape Town, said: “This is a critical study in our resource-limited context; working towards an affordable oral treatment for COVID-19 where vaccine access remains limited is of the utmost importance.”
Nitazoxanide, a clinically approved and affordable to manufacture antiparasitic drug, has previously shown broad-spectrum antiviral activity against coronaviruses and was identified as a promising candidate for repurposing at a higher dose by researchers at the University of Liverpool’s Centre of Excellence in Long-acting Therapeutics (CELT).
Pharmacokinetic modelling and preclinical validation work by the team found that the doses of nitazoxanide needed to inhibit SARS-CoV-2 replication may be achievable in humans but at doses higher than those currently approved for treating parasite infections.
Now, following successful preclinical and Phase Ia testing in healthy participants at the NIHR Liverpool and Broadgreen Clinical Research Facility in Liverpool1, AGILE has opened its first international site at the Desmond Tutu Health Foundation at the University of Cape Town in South Africa for trials in people who have tested positive for COVID-19 with mild to moderate symptoms in the community.
The participants will be given 1500mg of nitazoxanide twice a day for seven days and will be closely monitored to confirm that the dose tested in healthy people is still safe and well tolerated in people with mild COVID-19. The levels of the virus present in their bodies will also be monitored, and if the trial shows a benefit to patients, the treatment will be moved into a larger Phase II trial in South Africa.
AGILE’s partners for the study in South Africa are the Desmond Tutu Health Foundation at the University of Cape Town and Ezintsha at the University of the Witwatersrand.
The trial is being funded by Unitaid as part of a £2.2 million award to AGILE to support the COVID-19 response.
For more information, please visit https://www.agiletrial.net/
This press release was originally published on the AGILE website, and can be viewed here.