PRESS STATEMENT FROM PRESIDE FOR THE LAUNCH OF THE CLINICAL TRIALS OF UBV-01N 27/01/2021

Wednesday 27th January 2021

Since March 2020, Uganda has been battling COVID-19. There are 39,188 confirmed COVID-19 cases, with 433 active cases and 318 deaths. To date, there is no confirmed COVID-19 treatment. We thank the physicians who have worked hard to balance the different available medicines to control COVID-19 and thankfully many patients have recovered successfully. His Excellence the President has effectively led the country in the fight against COVID-19.  As chair of the National Task Force he created relevant platforms to address the multiple aspects of the pandemic.  One such platform is the Presidential Scientific Initiative on Epidemics (PRESIDE)- which is 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, PRESIDE 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. PRESIDE works with scientists in multiple research institutions and brings together expertize to work on specific solutions. The product going into this clinical trial is a result of this rigorous process of analysis, validation, approval and certification by the regulatory authorities in Uganda.

In April 2020, The Natural Chemotherapeutics Research Institute (NCRI) presented its proposal to PRESIDE to produce natural chemotherapeutic products to treat viral and bacterial infections. During the scientific hackathons, the NCRI researchers presented the literature that proved the scientific concept of their proposal and they were funded.

Since April 2020, the NCRI researchers led by Dr. Grace Nambatya Kyeyune, have worked tirelessly through all the rigorous processes to come up with a scientifically proven product that is ready for clinical trials now. The government through the Ministry of Finance, provided funds that were channelled through the Ministry of Science, Technology and Innovations (MOSTI) to procure equipment and meet operational costs.  

Today we are witnessing the first clinical trial of a highly scientific process to analyse and validate a natural product anticipated to have antiviral (kill viruses), anti-inflammatory (reduces over reaction of the body to infections) and immunological (directs the immune system in the right direction) ability.

The clinical trial will validate the content, standardization and replication of the product after which it will be rolled out for industrial production and wide spread 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. A highly competent team in Mulago Hospital will conduct the trial. 

The product code is UBV-01N. It is the first Ugandan natural chemotherapeutic product to go through an international level clinical trial process.     

 

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 is a big milestone for the natural chemotherapy industry and giant step for Ugandan Scientists. Quoting Professor Moses Joloba, the Dean School of Biomedical Sciences Makerere University College of Health sciences and one of the Scientists involved in product development said, “It is one thing to be a laboratory researcher and another to be a product manufacturer”. Today 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.

The research team include 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).

The study 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.

We want to congratulate His Excellency the President for having faith in the Ugandan Scientists, the natural chemotherapeutic society in Uganda, the scientific society, which is spending sleepless nights to develop different products and tools to respond to epidemics.

We appeal to Ugandans to welcome the clinical trial and willingly participate in when asked to volunteer. The product has been proved safe and the trial is basically to prove its efficacy against COVID 19. If you have tested positive for Covid-19 and would like to participate please contact the Clinical Coordinator on +256-782-404431