Uganda has launched the clinical trial of its COVID-19 treatment drug and awaits the results of the process to see of the process. The drug was launched on January 27.

Code-named UBV-01N, the drug was launched at Mulago Hospital by President Yoweri Museveni, who hailed Ugandan scientists for the development, saying it validates his push for improved remuneration for professionals.

“You must build an independent Uganda. We are working on the vaccine and treatment by ourselves. I do not know the problem of Africans. How can you sit here dying while waiting for Europeans to come and help you? I cannot accept it,” Museveni said.

The lead scientists in the trial are Dr Grace Nambatya, the head of the Natural Chemotherapeutics Research Institute (NCRI), Dr Robert Nakwagala, (co-investigator), Dr Fred Nakwagala (site clinical co-ordinator) and Dr Bruce Kirenga (senior clinical trial clinician). Others are Dr John Bisaba, the clinical trial clinician, Prof Pauline Byakika (scientific adviser) and Prof Noah Kiwanuka (biostatistician).

The institutions involved in the exercise are NCRI, Makerere University School of Public Health, Makerere University Lung Institute and Mulago Hospital.

The research and trials are funded by the Government of Uganda through the Presidential Science Initiative on Epidemics (PRESIDE) and the science and technology ministry.

The trial will involve administering the drug to 124 patients aged 18-75, who have COVID-19 symptoms to enable scientists analyse and validate the safety of the drug. If proven effective and safe for humans, it will be the first Ugandan natural chemotherapeutic product to go through an international level clinical trial process.

According to the statement from PRESIDE, UBV-01N is a natural chemotherapeutic product developed by the Natural Chemotherapeutics Research Institute through a series of vigorous scientific processes.

“We are witnessing the first clinical trial of a highly scientific process to analyse and validate a natural product anticipated to have antiviral, anti-inflammatory and immunological ability,” the statement reads.

“This clinical trial will validate the content, standardisation and replication of the product, after which it will be rolled out for industrial production and widespread use,” the statement further reads

THE TRIAL

Dr Monica Musenero, the senior presidential adviser on epidemics, says the drug under study is a combination of natural products that were already being used in Uganda.

She, however, declines to disclose the main ingredients of UBV-01N and the person or people behind it, arguing that it is standard practice to protect the patent interests of any product.

The trial is being done on consenting COVID-19 patients at Mulago Hospital. Other regional hospitals may participate in the trial after due process is followed. Patients taking part in the trial will receive standard care in addition to the trial medicine.

Fred Ssekyana, the National Drug Authority (NDA) spokesperson, says the UBV-01N herbal product was approved by all regulatory agencies NDA, Uganda National Council for Science and Technology (UNCST), Uganda National Health Research Organisation (UNHRO) and Mulago Ethics Committee.

The process

To have a clinical trial authorised in Uganda, a researcher has to submit an application to the Research Ethics Committee (REC), which is an institutional board in a hospital or academic institution. Then the committee reviews the ethical and scientific aspects of the trail for approval, renewable annually.

After REC approval, the researcher has to submit the proposal to UNCST, which is mandated through an Act of Parliament to register all research of this nature in the country.

UNCST does quality control for the RECs, which are accredited and supervised by it. The council also liaises with the Office of the President, which clears any issues related to national security.

It then issues a one-off research permit and its approval is renewable every two years or more as may be determined.

NDA is the final body to issue a clinical trial certificate for drug-related exercises. NDA reviews the risks versus benefits of the drug to be investigated in the proposed study population.

However, upon getting REC’s approval, a researcher may simultaneously apply to UNCST and NDA, but NDA’s final decision is issued only upon clearance from UNCST as indicated in the Act.

Up until now, all drugs for trials have been imported. And, even then, the NDA certificate is needed to allow the researcher apply for authorisation to import the trial drug.

The importation process involves verification of documents as well as the actual shipment at the port of entry. The clinical trial certificate is renewable every year.

Following initial authorisation, the researcher may amend their clinical trial for one reason or another.

Amendment of a trial also requires approval of the REC and NDA (if the amendment is substantial as defined in the relevant guidelines).

HOPES

Ugandan scientists are optimistic about the ongoing trial.

Musenero says she is confident the product can be used across the country for treating COVID-19 patients.

“We have started with herbal because many medicines originate from natural sources. There is a lot of evidence that herbs contain mixtures of ingredients in their natural form, which may augment action. If effective, we can in future purify ingredients,” Musenero says.

Dr Richard Idro, the president of the Uganda Medical Association, welcomed the development, saying it comes at a time when there is no specific treatment for COVID-19. So, any intervention effort is welcome.

He has, however, calls for rigorous tests and adherence to trial protocals so that the product does not end up having a bad effect on people’s health and embarrassing Ugandans.

“We are happy that our people have come up with a natural remedy and scientists are subjecting it to world standard tests.

Dr Bruce Kirenga, the director of Makerere University Lung Institute, says he had very high hopes in the trial.

“When this product was discovered by Dr Nambatya’s group, they brought it to us as clinical scientists to evaluate it,” Kirenga, who is treating COVID-19 patients at Mulago hospital, says.

“We tried it in animal models and as clinicians, we reviewed the data and evidence from these trials,” he adds.

Kirenga, who is a senior clinical trial physician, says they also organised a meeting with people who have been using the drug from the community.

“The testing of products in humans is a long and vigorous process, which comprises four phases. After preclinical trials like Dr Nambatya has said, they worked with communities,” Kirenga further explains.

DRUG TRIAL PROCESS

Musenero says phase one of the trial was skipped because the drug was effectively assessed for safety in normal individuals. What Mulago Hospital is now doing is phase two of clinical trial

“We needed to move quickly and once the drug’s safety was established, we launched this phase 2. We completed the tests in animals and we also have other sources of information about safety of the product,” she says.

A clinical trial is only done when there is good reason to believe that a new drug may improve the health of patients. Before clinical trials, the drug must have been proven to be safe and effective on paper and reviewed by experts before being tried out on animals. It is only when there are no safety issues in animals that tests in people are authorised.