Just In: M7 Launches Covid-19 Clinical Trials

President Yoweri Kaguta Museveni today, officially launched the first Uganda Coronavirus clinical trials at Mulago Referral Hospital.
The Plasma Investigational New Drug and the CCP trial to assess the safety and efficacy of CCP in treatment of COVID 19 in Uganda.
H.E Museveni in his address,he gave the green light to the scientists to commence (with immediate effect) the CCP trial now that the product and funds were available. He was pleased by their innovation.
He appealed to the general public to continue observing the COVID-19 Standard Operating Procedures as scientists continue to innovate, find treatment and cure for the deadly virus.
He said the country had reached phase 4 of the pandemic and the virus was now killing on average 2-3 people a day. This she noted was/ is widespread community transmission of COVID-19 meaning that the spread can no longer be controlled but can only be mitigated.
He emphasized that COVID-19 in Uganda is real so anything proven that can be done to save a life is highly welcome and appreciated.

The project is being conducted by the COVID Research group (COVIDRES) group; a multi-disciplinary research group coordinated by the Makerere University Lung Institute (http://mli.mak.ac.ug). Other partners on the project are Uganda People’s Defense Forces Medical Services, Mulago National Referral Hospital, Joint Clinical Research Center and Uganda Blood Transfusion Services. The team is now moving forward to undertaking the CCP trial.

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 Excellency 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.

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.

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