After months of research and other lab activities, Ugandan scientists have today commenced clinical trials for a locally-produced regimen aimed at Covid-19.
The scientists from The Natural Chemotherapeutics Research Institute (NCRI), who are led by Dr. Grace Nambatya Kyeyune, began their work in April of last year and they were work was funded by the government through the Ministry of Science, Technology and Innovations (MOSTI).
“Today we are witnessing the first clinical trial of a highly scientific process to analyze and validate a natural product anticipated to have antiviral (kill viruses), anti-inflammatory (reduces overreaction of the body to infections) and immunological (directs the immune system in the right direction) ability,” the Presidential Scientific Initiative on Epidemics (PRESIDE),” PRESIDE said in a statement.
According to the statement, the clinical trial will validate the content, standardization, and replication of the product after which it will be rolled out for industrial production and widespread use.
“The product has already gone through multiple quality assurance steps and got all necessary certifications and approval for use in human beings in a clinical trial setting,” reads the statement.
The trial will be conducted by a “highly competent team” in Mulago Hospital, officials say.
The product code is UBV-01N and it is the first Ugandan natural chemotherapeutic product to go through an international level clinical trial process.
When Covid-19 was confirmed in the country, President Museveni instituted the PRESIDE, a think tank of scientists with a core mission of developing products and tools to respond to COVID -19 and other epidemics.
Since March 2020, the Initiative has held scientific hackathons to engage scientists to develop various products in the areas of Vaccines, Therapeutics and Diagnostics.
As a result, a total of 23 projects have been funded through PRESIDE. The aforementioned product is one of them.
Officials say the National regulatory authorities that have approved the product include National Drug Authority (NDA), Uganda National Bureau of Standards (UNBS) and National Council for Science and Technology.
The launch of the clinical trial, officials say, is “the convergence point between the conventional medical fraternity and the natural chemotherapy, which is going to revolutionize the pharmaceutical industry and the private sector in the country.”
The results of the clinical trial will be internationally accepted because a good team of clinical trial experts have been instituted, officials say.
The research team includes Ugandan scientists based at Natural Chemotherapeutics Research Institute, Ministry of Health in collaboration with those in Makerere University School of Medicine, Makerere University Lung Institute, Makerere University School of Public Health, Mulago Hospital and Presidential Scientific Initiative on Epidemics (PRESIDE).
According to the Preside statement, the trial is aimed at enrolling 128 participants. The target participants will be adult males and females aged 18-70 years with a positive COVID-19 test and admitted at Mulago national referral hospital.
“For female patients, they should not be pregnant or breastfeeding or intending to get pregnant during the period when the trial is taking place,” experts have advised.