Ghana is one of the 13 countries participating in the ANTICOV clinical study, whose goal is to identify treatments that could prevent mild-to moderate COVID. The internationally recognized biomedical research institution the Kumasi Center for Collaborative Research in Tropical Medicine (KCCR) has been leading the trial in Ghana, in collaboration with the Bernhard Nocht Institute in Germany.

We spoke with the principal investigator of the trial, Dr John Amuasi, as KCCR began to recruit its first patients this June. A medical doctor by training, Dr Amuasi leads the Global Health and Infectious Diseases Research Group at KCCR. Dr Amuasi’s primary affiliation at KNUST is the Global Health Department at the School of Public Health, but he also heads the Community Medicine Department of KNUST School of Medicine and Dentistry and leads the Secretariat of the African Research Network for NTDs.

Dr Amuasi, what is the impact of the Delta variant in Ghana?

This third COVID-19 wave – that has hit many African countries harder than the previous ones – also hit Ghana. In early July, the country officially confirmed that the presence in the community of the Delta variant – which may even have been present for much longer. We need more evidence, but it is highly probable that Delta is responsible for the current surge of cases in Ghana.

What is interesting is that the ANTICOV trial gave us, three weeks in advance, some important insights on the changing trends of the incidence rates that correlate with what we are seeing now.

Here in Kumasi we adopted a very broad approach to recruitment for the trial: we conduct a mass screening of all potential COVID patients that are reporting to health facilities. Over the past three weeks of recruitment, we are moving from a rate of 10% to 20% of people who are diagnosed positive for COVID to almost 50%. The absolute number of infected people is also going up.

Since we don’t have a very robust surveillance system at the national level, ANTICOV gave us a unique view of the COVID epidemiological situation in Ghana.

Are you worried by this third wave fuelled by the Delta variant?

I am very concerned, naturally. We are seeing an increase in the infection rates, which is slowly transitioning into an increase in the hospitalization rates, which means a heavier burden on the health system. For now, death rates are not going up. Whether this will happen ever, sooner or later, we cannot tell yet.

So far – at least in the urban centres – the ICUs are not overwhelmed and there are enough ventilators.

But things can change rapidly. During the second wave we came very close to breaking point.

An issue of great concern is that only a little over 400,000 people in Ghana, barely 1,3% of the population, is fully vaccinated, even though we are benefiting from the COVAX scheme. Vaccination is perhaps the single most important issue to address the risk of mass deaths or morbidity from COVID. With so few people vaccinated, should Delta hit Ghana the same way it hit other parts of the world, the situation will be dire.

What could provide a little comfort is that a high number of people may already have COVID antibodies, which means that you might not need to vaccinate up to 70% of people to reach the proverbial herd immunity. 30% or 40% might suffice. In fact, from the work we have done, we estimate that about 40% of the population in Kumasi have antibodies.

‘If we want to address COVID beyond vaccination, the next most powerful tool will be a drug that can treat mild-to-moderate cases.’

DR JOHN AMUASI

What are your expectations about ANTICOV?

ANTICOV is perhaps the single most important trial on COVID being conducted in Africa right now. And I don’t say this because I’m a part of it! We observe that the vast majority of COVID cases in Africa are mild to moderate, which raises many questions. Focusing on mild to moderate cases from the beginning was a remarkable foresight.

It also means that, if we want to address COVID beyond vaccination, the next most powerful tool will be a drug that can treat mild to moderate cases – and that can also lower transmission rates. The ANTICOV trial is in pole position to answer these crucially important questions.

The most exciting part of this study is its adaptive nature, which means we can always drop or insert treatments at different points in time. I hope it will allow us to provide answers for what works and what does not, to design and develop effective responses.

Could you explain the three different studies that are being conducted within the ANTICOV framework?

Clinical trials are typically aimed at demonstrating that a drug works better than another one, or than no drug at all. But beyond being able to say that a drug works, we also need to understand the dynamics of the disease and how the drug would play a role in real-life settings, in both improving the health of the patient and also of the people within their immediate environment.

This is where the epidemiology study of ANTICOV comes in. Its objective is to understand if and how the disease can be transmitted by the infected people who are treated with the drugs we are proposing.

The other ‘ancillary study’ of ANTICOV is looking at how does the disease pans out serologically: does taking of drugs impact on the production of antibodies? How long do they stay? What is their neutralizing power? Understanding this is also critical.

Is it challenging to conduct such a complex trial?

ANTICOV is a clear demonstration of the capacity in Africa to conduct robust and extremely complex studies – I mean, no kidding, ANTICOV is a very complicated study. Even those who were at the fore front of designing it are only appreciating now the complexity of the beast we are trying to put in motion!

The second thing ANTICOV reflects is how well, when we really want to, we can collaborate at various levels within and across Africa, with PDPs (product development partnerships) such as DNDi, governments like Germany, and with UN bodies such as the World Health Organization (WHO). It shows how research institutions, researchers on the ground, healthcare systems, PDPs and then more regional and global health stakeholders can cooperate.

ANTICOV is a beautiful example of what can really work.

This interview was conducted on 9 July 2021.

Photo credits: Kenny Mbala-DNDi, The Touch Photos

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This story was published by ISGlobal on 27 July 2021 and is available in English, Spanish, and Catalan.

The two centres in Mozambique that ISGlobal is working with on the large-scale ANTICOV clinical trial have started recruiting participants, following in the footsteps of the Democratic Republic of the Congo, Ghana, Guinea, Kenya, and Mali. The aim of the trial, which is being conducted in 13 African countries, is to find an effective treatment to prevent progression of mild or moderate COVID-19 to severe disease.

ANTICOV will test different treatments. One of them is a combination of nitazoxanide, a well-known anti-parasitic drug that would be administered for its potential antiviral effect, and ciclesonide, an inhaled corticosteroid with an anti-inflammatory effect. Both drugs are already commercially available, affordable, safe, and easy to administer.

The Manhiça Health Research Centre (CISM) and the Polana Caniço Health Research and Training Centre (CISPOC), which is affiliated with Mozambique’s National Institute of Health, are ramping up their recruitment processes as the incidence of COVID-19 increases rapidly across Mozambique.

‘We are at the peak of COVID-19, with two main hotspots, one in the capital city of Maputo and the other in the north-western province of Tete,‘ explained Patricia Pérez, Paediatrician and Coordinator of ANTICOV in Mozambique. The predominant viral variant is now Delta, although the South African variant also continues to circulate. Meanwhile, just 1% of Mozambique’s population is fully vaccinated. ‘With more than 1,000 new cases and 15-20 deaths each day, diagnostic services are starting to be overloaded, hospital beds for COVID-19 patients are running out and oxygen supplies are becoming scarce,‘ Pérez continued.

It is important to remember that the intensive care infrastructure is limited in Africa and that the continent’s health systems are weak and already under pressure due to other infectious diseases. ‘In addition, physical isolation and quarantines are practically impossible,‘ added Elisa López, ANTICOV’s Co-Principal Investigator in Mozambique.

After Mozambique, the project is preparing to start recruiting soon in Côte d’Ivoire, Ethiopia, and Burkina Faso. ‘Altogether, across all of the countries, we expect to have 300 participants by the end of August and we hope to announce the initial results of the trial at that time,‘ commented Laura de la Fuente, Project Manager for ANTICOV in Mozambique.

In the coming days, recruitment will also begin in Mozambique for an immunological trial—one of ANTICOV’s two ancillary studies—that ISGlobal is co-leading with Belgium’s Institute of Tropical Medicine Antwerp (ITM). This study will be conducted in six countries and aims to analyse whether the treatments tested in the clinical trial in patients with mild or moderate COVID-19 alter the strength and duration of the immune response to SARS-CoV-2. ‘Knowing how long immunity lasts is especially important in Africa, where vaccination levels are very low,’ commented Gemma Moncunill, an immunologist at ISGlobal and Scientific Coordinator of the study.

26-Member Consortium

ANTICOV is a consortium of 26 prominent research and development organisations, including ISGlobal, a centre supported by the ”la Caixa” Foundation. The project is coordinated by the Drugs for Neglected Diseases initiative (DNDi). ANTICOV is a flexible and innovative “adaptive platform trial” that allows treatments to be added or removed from the study as more knowledge is gained about them.

Information for the selection of drugs to test in the ANTICOV trial is obtained from reviews conducted by the Access to COVID-19 Tools Accelerator (ACT-A) Therapeutics Partnership, which is co-convened by Unitaid and the Wellcome Trust.

Major funding for the ANTICOV consortium is provided by the global health agency Unitaid as part of ACT-A and by the German Federal Ministry of Education and Research through KfW. It is also supported by the European & Developing Countries Clinical Trials Partnership (EDCTP), the Starr International Foundation, and the Stavros Niarchos Foundation (SNF).

Photo credits: Gemma Moncunill / ISGlobal, CISM / ISGlobal

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The Principal Investigator of the ANTICOV trial in Mali is Dr Samba Sow. He is a medical doctor, epidemiologist and Director of the Centre pour les Vaccins en Développement (CVD-Mali) du Ministère de la Santé du Mali, a public organization doing research and training on infectious diseases.

Dr Sow is a widely-recognized public health authority in the region: he was Minister of Health and Public Hygiene for Mali from 2017 to 2019 and was appointed in 2020 WHO Special envoy for COVID-19 in West Africa.

Dr Sow, what is the impact of the COVID-19 pandemic in Mali right now, in June 2021?

It is having a huge impact, not only in our daily lives but also on the delivery of primary care and on our healthcare system – which were already under major stress. We were not ready for such an emergency. Key health care activities such as maternal and child health, prenatal visits, childbirth, etc., delivery of treatments for tuberculosis, HIV, leprosy, malaria, or national programmes such as the one against blindness have been disrupted.

The repercussions on public health will be frightening and I am very worried for the future. To rebuild our healthcare system, it will require lots of time, efforts, energy, and collaborations.

I am also concerned by the attitude of many Malians, who seem to think that since vaccines now exist, the pandemic is over. The exact contrary is happening – it is getting worse. An aggravating factor is that our screening and pandemic surveillance activities are not working properly, which means we have trouble to evaluate the epidemiological situation.

What should be Mali’s answer to this massive public health crisis?

We need to open as many collaborations as possible. In the global fight against infectious diseases, a country can never go alone. Even a continent cannot go alone. The answer should be global. This is why ANTICOV is so important.

Even the most remote places, from every corner of the world, must join this global effort as early as possible, from the research phase, to become part of the solution. This is what my own country, Mali, must do.

We can see that vaccine research, for example, started in countries with high incomes and that this effort converted very fast into public health responses. The more deeply a country is involved in medical research, the easier it is to rapidly develop a response – because the results from this research are informing recommendations, policies, and public health decisions. If you do not conduct research from the start, you end up at the back of the queue. This is why Mali joined ANTICOV.

Could you explain your role in the ANTICOV trial?

I am the principal investigator, which means I am in charge of following, coordinating, and supervising all scientific, technical, administrative, and communication activities of the trial. A principal investigator is a linchpin of the trial and must spend a lot of time on the field, to work with his team and talk to the communities. A principal investigator cannot do anything without a strong team, and I am lucky to have one! Approximately 40 people are working directly on the ANTICOV trial in Mali.

‘In the global fight against infectious diseases, a country can never go alone. The answer should be global. This is why ANTICOV is so important.’

DR SAMBA SOW

What are your expectations for the trial?

It is critical that ANTICOV succeeds. A success will be crucial for Mali and for all Africa – not only for the 13 participating countries.

ANTICOV’s objective is to find treatments for mild to moderate cases of COVID. These  are the most frequent cases we are seeing, and they are fuelling most community transmission. The number of beds in intensive care units in Mali is very limited, which means we must cure patients before their symptoms become severe. This is why this study is important.

Today, when we are talking treatments or vaccines, Africa is not in a good position. It is very important that Africans and African research organizations join the global effort to conduct trials.

How you do gain trust with your communities, to ensure that they will participate in the trial?

This is a very important question.  Without communities’ trust and support, even with the best study protocol of the world, you will go nowhere.

Fortunately, at the CVD-Mali, we are working closely and very early on with communities: we discuss with them the trial protocols as soon as they are approved. In every village, neighbourhood, or ‘commune’ we meet with representatives such as traditional or religious leaders, presidents of cultural, youth or women associations, etc.

Sometimes, during those meetings, people express doubts and have difficult questions. So we open our labs to them, we show them what we do with the samples we collected, we explain them the drugs we will distribute. These are truly transparency operations.

This is how we can convince communities that they will be the first to benefit from the research we do with them.

Photo credit: CVD-Mali

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On Friday 18 June, the first Kenyan patient was enrolled in the ANTICOV clinical trial. Kenya is the 5th country after the Republic of Guinea, the Democratic Republic of Congo, Mali and Ghana to start this large pan-African, collaborative scientific study whose objective is to identify treatments for mild to moderate cases of COVID-19.

The Principal Investigator supervising the trial in Kenya is Dr Bernhards Ogutu. He is a trained paediatrician, clinical pharmacologist, Chief Research Officer at the Kenya Medical Research Institute (KEMRI) and Director of the Centre for Research in Therapeutic Sciences (CREATES) at Strathmore University, Nairobi.

Dr Ogutu, how is the COVID-19 situation in Kenya today?

I am worried. Hospitals have been observing more admissions than previously, with a number of people with severe disease coming in. The test positivity rate still remains high and is averaging 10%. But schools and parts of the economy have reopened, and we don’t know how the situation will pan out.

Despite this worrying trend, it is still difficult to convince people to adopt appropriate precautionary measures. Initially, when the first wave hit, people were a bit scared, and they listened when the first prevention measures were put in place. But now, some people feel they are safe since a few have been vaccinated; other still believe that only urban areas are affected and they are not at risk in rural areas – which is not true.

The vaccination situation is not good: we have only limited doses and the supplies are not forthcoming.  We need much more.

We need to continue looking for other health tools, in particular treatments to cure patients already infected with COVID-19.

This is why the ANTICOV clinical trial is so important.

Could you explain your role in the trial?

I am leading the ANTICOV study in Kenya. I need to ensure all the stakeholders are engaged and that all the questions the communities might have are answered. It is very important to explain to the public why we need ANTICOV right now, even though vaccines are coming.

ANTICOV researchers are focusing their efforts on mild to moderate cases, to find treatments that could prevent them from becoming severe. This is closer to prevention, because treating mild cases early can be much cheaper and effective than treating severe cases later. And it could save lives, especially in environments with limited ICU capacities.

‘A positive or a negative result from the trial will go a long way in shaping the policies of how COVID-19 is managed on the continent.’

DR BERNHARDS OGUTU

What are your expectations for the ANTICOV trial?

There are many, but the main one is that ANTICOV will generate data to inform national guidelines. I sit on the National Task Force for COVID-19, and we are looking at a number of ways to treat patients. Unfortunately, we have no clear data on what treatment works for mild to moderate cases.

That is why we need to generate this data to inform the governments and the Ministries of Health on what really works and what does not, so they can make the appropriate decisions and adopt the right guidelines for their populations.

This is critical. A positive or a negative result from the trial will go a long way in shaping the policies of how COVID-19 is managed on the continent.

What will you do to gain trust with communities?

We are maintaining close contact with the communities especially in the region where the study is being carried out. We have been discussing the study with community leaders and we are ready. We also share transparently with the media all the information about ANTICOV to prevent any negative reaction. We have been explaining that we need to generate scientific data to know what drugs work for us, and that we do this for the public good.

People are more receptive because everybody knows somebody who suffered or died from COVID-19. A few sceptics still remain, but the majority are ready to listen. We had a number of appearances with media and televisions, some people wrote opeds, to make sure the communities understand the disease.

We will also explain to each participating patient to the trial that we are looking for a treatment that is tailored to their needs and that will work in their communities. It is crucial to detail the rigorous system that has been put in place to review the results and to ensure that the research we do is ethical, appropriate, and done well. This robust system of review and evaluation ensures that no one can do anything that would harm the population.

I think such sustained and positive communication is going to be key to build and maintain the trust of communities.

Any last words?

First, I would like to highlight the fact that this is the first time we are using an adaptive design as a platform for a large-scale clinical study in Kenya. Analysing the outcomes will be very interesting to evaluate how this new type of study design can be useful and can accelerate the development of knowledge. If it goes well, the findings of ANTICOV will be a very important milestone in the framework of clinical trials and in managing future pandemics.

Finally, this study shows that even in a pandemic, the global community can come together at short notice, set up a platform in a framework that is cost-effective, and develop and evaluate medicines for a new disease, in less than a year. This could create a new way of looking at how we can develop medicines for these urgent situations.

Photo credit: KEMRI, DNDi

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