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Inside Uganda’s New COVID-19 Therapeutic Drug

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President Museveni will this Wednesday preside over the launch of a locally-developed therapeutic drug to treat COVID-19, Chimp Corps report.

The event will be held at Mulago Women’s hospital at 10:00am, according to presidential spokesperson, Don Wanyama.

Makerere University said in a Tweet this Wednesday morning: “…the President is expected to launch a therapeutic drug for the treatment of COVID-19. The drug was developed by Makerere Researchers in collaboration with Mulago Hospital.”

Since March 2020, Uganda has been battling COVID-19 which has ravaged the economy and killed hundreds of people.

There are 39,188 confirmed COVID-19 cases, with 433 active cases and 318 deaths.

To date, there is no confirmed COVID-19 treatment.

ChimpReports understands that as chair of the National Task Force to combat COVID-19, President Museveni in 2020 created several platforms including the Presidential Scientific Initiative on Epidemics (PRESIDE)-to address multiple aspects of the pandemic.

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 held scientific hackathons to engage scientists to develop various products in the areas of Vaccines, Therapeutics and Diagnostics.

Officials said the product going into today’s clinical trial is a result of this “rigorous process of analysis, validation, approval and certification by the regulatory authorities in Uganda.”

How it started

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.

President Museveni’s temperature being checked at Entebbe International Airport in 2020

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 channeled 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 analyze 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,” reads a statement from Presidential Scientific Initiative on Epidemics (PRESIDE).

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.

SAVING MONEY

If produced on a large scale, the locally-made drug could see Uganda save millions of dollars in importing vaccines from developed countries.

Health Ministry Permanent Secretary Dr Diana Atwine recently said a “working estimate” of $405m would be spent on COVID-19 vaccine programme but that the final figure would be determined by a response from the COVID-19 Global Vaccine Access Facility (COVAX facility).

“Uganda, like other Low and Middle Income Countries intends to access AstraZeneca’s COVID-19 vaccine through the COVID-19 Global Vaccine Access Facility (COVAX facility),” said Atwine last year.

Ugandan scientists under PRESIDE said their drug 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 – the first Ugandan natural chemotherapeutic product to go through an international level clinical trial process.

Approvals

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, according to Ugandan officials.

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”.

He added: “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).

Participants

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.

Government appealed 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,” said PRESIDE.



Source – ChimpReports

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