Ugandan President Orders Funds for Ivermectin Prophylaxis Clinical Trial TrialSite Staff

The President of the Eastern African nation of Uganda, Yoweri Museveni, recently directed that nation’s Ministry of Finance, Planning and Economic Development to release approximately $841,000 to support the research of ivermectin as prophylaxis in the treatment against SARS-CoV-2, the virus behind COVID-19. Museveni last year directed the medical team of the national military known as Uganda People’s Defense Forces (UFDF) to investigate use of the generic, U.S. Food and Drug Administration (FDA) approved antiviral as prophylaxis against COVID-19. That study found that ivermectin delivered positive efficacy, particularly in vulnerable populations (e.g., at-risk such as the elderly). TrialSite reminds all that President Museveni has declared funds for other studies which were delayed due to bureaucratic entanglements.

In a recent letter from the President to the finance minister Matia Kasaija dated February 22, 2022, and reported on by local media including the Independent, the President pens:

The team needs to carry out a well-designed randomized controlled study to evaluate the dosing and scheduling of ivermectin. The findings will inform policy and guide on ivermectin prophylaxis’ effectiveness in the treatment of COVID-19.” He continued, “To be able to carry out the studies, the team requires shillings 3,024,150,500. I am, therefore, directing that you avail the funds to the team to complete the trials.”

The Drug

Before COVID-19 ivermectin was considered a “wonder drug,” but now has been relegated to something quite different given the controversy over the use of the drug as a treatment against COVID-19. 

With 81 studies completed, a majority of them show several positive data points. However, a few high-profile specific studies failed to turn up any positive efficacy, such as the TOGETHER study. Results of that study again have been broadcast all over the place as of late, even though that study occurred some time ago. Another sizeable study, Medina-Lopez, failed to show any efficacy, yet some writers affiliated with TrialSite, such as Dr. Michael Goodkin, raised concerns about that study.

Generally, the medical establishments for much of the developed world don’t trust the mostly small studies conducted during the pandemic in low-and middle-income countries (LMICs).

Ivermectin is used extensively in this part of the world. The drug is included in the World Health Organization’s (WHO) essential medicines list for the treatment of several parasitic pathogens, including river blindness (onchocerciasis), scabies, and other relevant conditions.

Ugandan Ivermectin Study

Apparently, the first formal ivermectin study backed by UPDF and targeting COVID-19 in this African nation occurred at Makerere University College of Health Sciences.

One ivermectin study targeting early treatment was organized based on the fact that ivermectin demonstrated potential in vitro activity against SARS-CoV-2. In the study registry submission, it was reported that “Ivermectin has demonstrated broad-spectrum anti-viral activity and inhibition of the causative virus (SARS-CoV-2) with ability to cause a 5,000-fold reduction in viral RNA within 48 hours.”

Of course, this latter data points to the in vitro lab cell culture-based findings at Monash Universityas reported by TrialSite on April 5, 2020.

In relation to the ivermectin early treatment study last year, investigators at Makerere University College of Health Sciences discussed, “Although aspirin and ivermectin do not exhibit any synergistic or potentiation at the cellular level, a clinical additive effect resulting from combination therapy with low dose aspirin and ivermectin is plausible. There is no documented drug-drug interactions or another biological basis that contra-indicate co-administration of low dose aspirin and ivermectin.”

According to recent news out of Uganda, this previous exploratory randomized study which ran from February 2021 through September 2021 did demonstrate some efficacy for COVID-19 patients.

This study was led by Makerere University, College of Health Sciences’ Jackson Cuonzo, Ph.D. TrialSite has sent emails to the principal investigator for a comment on this study—any responses will be incorporated into an updated entry here.

The Trial Site

Makerere University, College of Health Sciences was established in 1924. It was known as Makerere University Medical School till 2007 when it became Makerere University’s premier constituent College. It is the oldest medical training University unit in East Africa, having been in the business of training medical and health professionals for over 80 years. This history has earned it an enviable position in Uganda and the East and Central African region.

By 2008, the Makerere University initiated substantial intuitional changes that led to the creation of the current Makerere University, College of Health Sciences as the University’s first constituent college.

COVID-19 in Uganda

With about 46 million people, Uganda represents the eighth-most populated country in the continent. Like many sub-Saharan African nations, Uganda has been comparatively unscathed given the nation’s population. For example, approximately 163,635 SARS-CoV-2 cases have been reported along with 3,595 deaths. Of course, these figures could be well undercounted.

The country has experienced a handful of surges, the worst being the Delta wave during the summer of 2021, representing the deadliest period of the pandemic.

Vaccine Status

About 17.5% of the country’s 46 million people have been fully vaccinated (two jabs), while about 30% have received at least one jab. An intense push to vaccinate more of the population against SARS-CoV-2 continues.

For example, at the Gulu District Health Department, public health officials target 156,755 residents in their second phase of the mass vaccination program. They are targeting 93,765 people for their first dose and another 62,960 for their second dose of the COVID-19 vaccine.

The health ministry controls the distribution of COVID-19 vaccine product, and in this most recent push, the majority of the vaccines are Johnson and Johnson (90,890), followed by Moderna’s mRNA-based Spikevax (6,518) and China’s Sinovac (1,573) doses.

Vaccine hesitancy in these parts is high as people do not seem that interested in inoculation. As reported in The Independent, Anifa Kawooya, State Minister for Health blames misinformation, spread throughout the community and in media, for the low vaccination rates in this country.