UGANDAN President Museveni yesterday launched the clinical trial for a locally-developed natural product for treatment of Covid-19, viral and bacterial infections.
The remedy unveiled has been created from a combination of natural products that were already being used in communities in the country, according to the scientists who developed it.
The product code-named UBV-01N, kills viruses, stops inflammations and modifies the work of body immune system, the properties developers say are important in curbing complications and deaths from Covid-19.
Museveni said Uganda shall not accept dependency.
“You must build an independent Uganda. We are working on the vaccine and treatment by ourselves. I don’t know the problem of Africans. How can you sit here dying while waiting for Europeans to come and help you? This, I cannot accept it,” Mr Museveni said.
He congratulated Ugandan scientists for coming up with the treatment solution, saying it validates his push for improved remuneration for professionals.
“This term of office, one of my seven priorities will be to ensure scientists are well paid. Even if we don’t have money, our scientists must get enough pay,” the President said.
The country had by Tuesday registered 39,261 Covid-19 cases and 318 deaths, according to the Ministry of Health statistics.
Dr Monica Musenero, the senior presidential adviser on epidemics, who also coordinates the work of scientists in the country, told Daily Monitor that if the trials are successful, the product will be Uganda’s first contribution to the world in terms of medicine.
“At the moment, we have no Covid-19 cure, we only have supportive therapies. If this drug comes out with clear effects on reducing deaths and chances of developing severe disease, this will be Uganda’s first contribution to the world in terms of medicine,” she said.
Dr Musenero explained that the trial, which will start next Monday, will be done among 124 Covid-19 patients admitted to Mulago hospital. She said the process will last for around 30 days or more depending on the number of patients enrolled.
The target participants will be adult males and females aged between 18 and 70 years with a positive Covid-19 test and admitted at Mulago hospital, according to Dr Musenero.
“We started at phase two of clinical trial because the product is very safe and we also needed to move quickly. We completed the tests in animals and the product proved very safe. We also have other sources of information about safety of the product,” she said.
At phase one of the trial, which was skipped, a product is assessed for safety in normal individuals, according to Dr Musenero. After completing phase two, the presidential adviser is confident that they will get emergency approval for the drug to be used across the country for treating Covid-19 patients.
Dr Grace Nambatya, the head of Research Natural Chemotherapeutic Research Institute, said the delay to unveil the product was due to the challenges in “procurement of standards”.
Standards are protein markers that are used to determine whether there are particular components in the product.
“They [standards] are tagged as hazards material, meanwhile we need them to be able to confirm to the regulators and gain the validation of the natural products..,” she said.
“We worked closely with Dr Musenero. We looked at other chemical analyses where we could probably identify those markers without those standards alongside government analytical laboratories and National Drug Authority,” Dr Nambatya added.
However, some scientists such as Daniel Kawuma, a pharmacist, are skeptical about the safety of the UBV-01N product to be tried in patients.
“What is the purpose of spending tax-payers’ money cutting ribbons for the launch of clinical trials on a laboratory chemical product that has no evidence yet of safety and efficacy?” he wrote in a tweet on Tuesday night
But Dr Bruce Kirenga, the director of Makerere University Lung Institute, who is treating Covid-19 patients at Mulago hospital and the senior clinical trial physician, said the product is safe and that they are ready to do the trial.
“When this product was discovered by Dr Nambatya’s group, they brought it to us as clinical scientists to evaluate it,” he said.
“The testing of products in humans is a long and vigorous process which comprises four phases in summary. Following preclinical trials like Dr Nambatya has said, they have been working with communities,” Dr Kirenga further explained.
“They brought this product and tried it in animal models. Those trials have been conducted and as clinicians, we review the evidence from these trials and in this case, we have reviewed the data form the animal study …,” he added.
Dr Kirenga said they also organised a meeting with people who have been using the product from the community.
“At phase two clinical trials, almost 60 per cent of the products do not survive, meaning they do not pass the test so this product is going to face a vigorous evaluation,” he said.
Health ministry speaks
Health minister Jane Ruth Aceng said the study will start at Mulago hospital and will be expanded to other facilities.
“The study will enrol adult patients who have various diseases and severe symptoms of covid-19,” she said, adding: “The study will be monitored by an independent safe data and monitoring committee established by the health regulatory agencies and the findings will be shared…”
Lead scientists in Covid-19 drug trial
Who is who…
1. Dr Grace Nambatya is leading the development and investigations for the safety and efficacy of the product. She is the director of research at Natural Chemotherapeutic Research Institute where the UBV-01N product was developed.
2. Dr Robert Nakwagala is the co-investigator in the clinical trial.
3. Dr Fred Nakwagala is working as the site clinical coordinator.
4. Dr Bruce Kirenga is the senior clinical trial clinician. He is the director of Makerere University Lung Institute and is treating Covid-19 patients at Mulago hospital.
5. Dr John Bisaba is the clinical trial clinician. He is treating Covid-19 patients at Mulago hospital.
6. Prof Pauline Byakika is working as the scientific adviser. She is an expert in infectious diseases and a member of the Ministry of Health Scientific Advisory Committee on Covid-19.
7. Prof Noah Kiwanuka is working as the Bio-statistician.
1. Covid-19 Convalescent plasma which uses blood from recovered patients to treat other cases. It is being led by Dr Bruce Kirenga as the lead investigator.
2. Hydroxychloroquine clinical trial. The drug is also used to treat Covid-19.
Clinical trials are important for discovering new treatments for diseases by showing what does and doesn’t work in humans, according to science.