As we shift from pandemic to endemic status for COVID-19 in many areas of the world, one thing remains constant: the need for equitable, global access to both investigational and approved COVID-19 vaccines and therapies. Since the beginning of the pandemic, FHI Clinical teams have led numerous COVID-19 research studies, and we’re proud to have contributed data that can be shared with the medical community worldwide. This post highlights one of these therapeutic studies currently being conducted throughout Africa.
African multinational clinical trial for COVID-19 therapies
For a multinational clinical trial of COVID-19 therapies being conducted in Africa, we are providing the following services in Ghana: site monitoring, site management, site and laboratory audits, medical writing and creating and managing the trial master file (TMF). We’ve mobilized FHI Clinical team members from Ghana, Kenya, Senegal and the United States, with FHI Clinical Project Manager Loice Mangaria, who is based in Kenya, leading the team.
The 13 countries in a multinational clinical trial for COVID-19 therapies
Current COVID-19 situation in these 13 countries
Only ~21% of the population. has been fully vaccinated, and another ~23% has been partially vaccinated. This is a far cry from the World Health Organization (WHO) goal of vaccinating 70% of the global population by mid-2022.
To date, 52 African countries have received 960.4 million vaccine doses from multiple sources including the Africa Vaccine Acquisition Task Team (AVATT) initiative, a regional collaboration between the World Bank and African Union; and COVAX, a global collaboration co-led by Gavi, the Vaccine Alliance, the World Health Organization (WHO) and the Coalition for Epidemic Preparedness Innovations (CEPI). This represents only ~8% of the 12.4+ billion vaccine doses that have been globally administered, let alone manufactured. Of the vaccine doses received by these Africa countries, 67% have been administered. The situations in the 13 countries highlighted above are shown in the table; despite relatively high utilization of the available vaccine doses, less than one-third of the population is fully vaccinated in most of the countries.
Snapshot of vaccination status in the 13 studied countries
Country | Vaccine doses administered | % vaccine utilization (of doses received) | % of the population who has been fully vaccinated |
|---|---|---|---|
Burkina Faso | 5,381,185 | 69% | 10.0% |
Cameroon | 2,783,468 | 71% | 4.4% |
Cote d’Ivoire | 13,653,880 | 49% | 19.9% |
Democratic Republic of the Congo | 6,382,362 | 30% | 2.7% |
Ethiopia | 52,277,493 | 75% | 30.5% |
Ghana | 20,315,922 | 63% | 24.1% |
Guinea | 7,789,134 | 82% | 18.5% |
Kenya | 22,993,181 | 66% | 16.6% |
Mali | 3,439,575 | 64% | 6.5% |
Mozambique | 30,690,174 | 80% | 44.1% |
Sudan | 11,188,214 | 71% | 9.9% |
Tanzania | 22,371,313 | 97% | 20.7% |
Uganda | 32,359,542 | 62% | 25.3% |
Sources: Africa CDC COVID-19 dashboard.,
Data current as of August 17, 2022.
Some of the hurdles that countries in Africa have encountered include inadequate vaccine supply, lack of ancillary supplies, insufficient cold storage, limited healthcare workforce, differing national priorities and vaccine hesitancy, exacerbated by circulating myths about the virus and vaccines.
Addressing the situation in Ghana
In Ghana, which was the first African country to receive vaccines through COVAX in February 2021, early efforts at vaccination were successful. Within 20 days of receiving that first allocation, more than 470,000 people in the hardest hit areas received their first dose from mobile vaccination teams supported by community mobilizers. This represented more than 60% of its first-phase priority population and ~90% of all health workers in the country. Years of previous experience with polio virus and routine immunization campaigns were credited for part of the success. Other contributing factors include clear, consistent government communication over multiple channels (radio, TV, social media, influencers, partner communications and community organizations) and the willingness of political leadership to show their support through live broadcasts of their own vaccinations.
However, only 63% of available doses have been administered, reaching only 24% of the population. As in many other countries, vaccine hesitancy is playing a role. Only 51% of respondents (aged 15 years and older) to an online survey said they would likely get vaccinated, while the remaining were unsure or unlikely to get vaccinated. Reasons for hesitancy reportedly include misinformation, mistrust surrounding the intent of vaccines stemming from a history of colonialism and the less-than-perfect execution of an Ebola vaccine trial.
Against this background, effective COVID-19 therapies that can be made rapidly available to infected individuals is vital to limiting the disease’s impact.
Repurposing existing drugs, such as antivirals, circumvent early-phase trials needed to demonstrate initial efficacy and safety, a lengthy ramp up of new manufacturing and establishment of distribution channels. Plus, drugs already being used to treat locally prevalent diseases can easily be made available for patients with COVID-19.
Evaluating existing therapies for their potential to treat COVID-19
Back to the adaptive, controlled study that we’re supporting in Ghana: multiple existing therapies are being evaluated for their efficacy against COVID-19 infection. Across the 13 countries, target enrollment is 2000 to 3000 adults at least 18 years old who have tested positive for COVID-19. The site in Ghana is on target to enroll the planned 216 participants within 1 year of beginning recruitment.
To be eligible, participants must be experiencing only mild to moderate symptoms that can be treated on an outpatient basis. Given the home-based administration of the study drugs, a call center supports the study by answering participant questions and contacting participants during the 14-day treatment period to collect data and ensure treatment adherence. Loice describes the study in greater detail in the video.
The study is ongoing. The outcomes could provide more treatment options for patients worldwide but particularly in areas that are struggling with vaccine coverage and have limited access to drugs requiring complicated distribution and administration.
Ensuring equitable access to vaccines and treatments
This is one of many COVID-19 studies with which our FHI Clinical teams have been involved since early in the pandemic. Another adaptive trial of already marketed therapies that we’ve supported is the Adaptive COVID-19 Treatment Trial (ACTT), a series of four Phase 3, randomized, double-blind, placebo-controlled trials conducted by the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID). Download our COVID-19 brochure to learn more about our support of COVID-19 studies across 30 countries and 43 states in the United States.
