The HonorHealth Research Institute and HonorHealth announced today the successful enrollment on a novel combination of atovaquone and azithromycin in patients with moderate-to-severe COVID-19 infection.
The clinical trial, conducted in collaboration with the Translational Genomics Research Institute (TGen), an affiliate of City of Hope, is funded as an investigator-initiated clinical trial by HonorHealth Research Institute. This is one of 10 clinical trials that the HonorHealth Research Institute is working on related to COVID-19 to understand the biology, spread and treatment of COVID-19.
"We are excited to launch this trial in patients with COVID-19 infection. The combination of atovaquone and azithromycin has been previously studied in other infectious conditions and we hope that if proven active, it may represent a well-tolerated option for patients infected with COVID-19," said Michael S. Gordon, M.D., Medical Director of HonorHealth Research Institute and co-Principal Investigator of the trial.
This is the first trial in the United States, and the first trial made available to patients in Arizona, that involves this specific combination of therapies.
We are proud to be supporting this 'home grown' innovation here at the Institute, where we have been working with other front line providers, scientists and experts across the globe to bring several COVID-19 trials up in record time to support our patients and providers amid this pandemic.
Kiran Avancha, PhD, RPh, Chief Operating Officer, HonorHealth Research Institute
The combination of atovaquone and azithromycin has the advantage of less risk of cardiac side effects compared to other potential COVID-19 treatments. Laboratory modeling suggests that atovaquone may be an active drug in the treatment of COVID-19 and its combination with azithromycin, studied in the rare infectious disease babesiosis, makes this an intriguing combination to study in COVID-19.
HonorHealth will be enrolling approximately 25 patients into the study, which enrolled its first patient on April 29. Eligibility criteria can be found on the ClinicalTrials.gov website.
The study will analyze interval nasopharyngeal swabs during treatment to quantitate COVID-19 viral load as well as assess additional clinical and laboratory determinants to determine response to therapy.
Additional laboratory studies performed by TGen's Pathogen and Microbiome Division, its infectious disease branch, will assess antibody production as well as genomic sequencing of the virus' RNA to gain a better understanding of the COVID-19 virus.
"HonorHealth and TGen are excited to be working together on this project and are hopeful that the translational research that is part of this and other studies TGen is conducting will open new avenues for diagnosis and treatment of COVID-19 in the future," said Sunil Sharma, M.D., FACP, MBA one of the clinical trial's principal investigators with dual appointments at HonorHealth Research Institute and TGen.
"We are hopeful that our analysis of antibody production will give us important insights about crucial targets for treatment in the future."
HonorHealth continues to assess options for improving management of patients infected with COVID-19. The HonorHealth Research Institute is focused on expanding its breadth of options to other programs in the Valley in an effort to develop a coalition against this serious health risk.