ANTICOV: largest clinical trial in Africa for people with mild COVID-19 to test new drug combination

Need for effective COVID-19 treatments remains particularly acute, especially in sub-Saharan Africa where access to vaccines is still extremely limited

Geneva – The ANTICOV clinical trial, conducted in 13 African countries, has started the recruitment of participants to test a new drug combination, nitazoxanide + ciclesonide, to treat people with mild-to-moderate COVID-19 before their cases become severe.

The ANTICOV study is being carried out by a consortium of 26 partners which include leading African research institutions and international health organizations, coordinated by the non-profit research and development (R&D) organization Drugs for Neglected Diseases initiative (DNDi). It is the largest trial in Africa to identify early COVID-19 treatments that can prevent progression to severe disease and potentially limit transmission.

“In many African countries our worst fears are being realised, as already-strained intensive care units are beginning to fill up with COVID-19 patients,” said Dr John Nkengasong, Director of the Africa Centres for Disease Control and Prevention (Africa CDC). “Yet the number of vaccine doses that are reaching the African continent is too limited. The rapid spread of new variants also threatens to reduce the efficacy of existing vaccines, which is another major cause for concern. We need urgently to identify affordable and easy-to-administer treatments that can prevent the evolution to a severe form of the disease and slow the rate of infection.”

The Africa CDC has recorded more than 117,000 deaths from COVID-19 on the continent; however, the true toll is estimated to be higher. And with new variants spreading, an increase in new cases is expected in the coming months.

ANTICOV is testing a new potential treatment that combines the well-known antiparasitic nitazoxanide and the inhaled corticosteroid ciclesonide. The combination has two different mechanisms of action that could work at different stages of infection: one that is potentially active during the first, viral replication stage of SARS-COV-2 infection and one that decreases the likelihood of an inflammatory stage that can start a few days later. Both drugs are already commercially available and will be affordable and easy to access and administer, if shown to be effective against COVID-19.

“It has been more than a year since COVID-19 was declared a pandemic, and while we have vaccines registered for use, there are still very few treatment options – especially for the early stage when we could prevent severe progression, potentially reduce transmission, and maybe prevent the risk of developing post-COVID condition,” said Dr Nathalie Strub-Wourgaft, Director of the COVID-19 Response for DNDi. “We still do not have a treatment for mild-to-moderate cases and this remains a research priority, in Africa – and throughout the world.”

The inclusion of the nitazoxanide + ciclesonide combination in a new arm of the ANTICOV study has been reviewed through the WHO-created African Vaccine Regulatory Forum (AVAREF) – which facilitated the regulatory process in each ANTICOV country – and by the WHO COVID-19 Research Ethics Review Committee.

“In addition to treatment options for patients with mild-to-moderate COVID-19, we also need a simple, easy-to-use, affordable, and reliable test that can be the backbone of test-and-treat programmes led by African governments,” said Dr Monique Wasunna, Director of the DNDi Africa regional office. “We fully support the work of our ANTICOV Consortium partner The Foundation For Innovative New Diagnostics (FIND), which is a co-convener of the ACT Accelerator Diagnostics Partnership, to accelerate diagnostic tools for COVID-19.”

The first participants in the new study arm have been recruited in the Democratic Republic of Congo (DRC) and the Republic of Guinea. In the coming weeks, additional trial sites will enrol participants in Burkina Faso, Cameroon, Côte d’Ivoire, Equatorial Guinea, Ethiopia, Ghana, Kenya, Mali, Mozambique, Sudan, and Uganda.

“As we face a mutating virus that challenges the tools we have to fight COVID-19, research into promising treatments has never been more important. It is vital to work out which therapeutics we can add to the existing package of patient care – and how they can be best-adapted for use in low-resource settings,” said Dr Philippe Duneton, Executive Director of Unitaid, which is partly funding the study. “Through the ANTICOV trial, Unitaid is investing in potential drugs to treat mild and moderate COVID-19 – a key gap in current treatment options that we must bridge to prevent hospitalisations and deaths.”

ANTICOV is an ‘adaptive platform’ trial, a flexible and innovative trial design that allows for treatments to be added or removed as new evidence emerges. The trial started in September 2020 with the HIV antiretroviral combination lopinavir/ritonavir and the malaria drug hydroxychloroquine. These two initial arms were suspended in December 2020 after WHO updated its treatment guidelines to recommend against the use of these drugs to treat COVID-19 patients, including patients with mild-to-moderate COVID-19.

The ANTICOV Consortium is now in the process of selecting and preparing the next arm of the trial. The selection of trial drugs for ANTICOV is informed by reviews conducted by the expert working group of the Unitaid and Wellcome-led Access to COVID-19 Tools Accelerator (ACT-A) Therapeutics Partnership.

Major funding for the ANTICOV consortium is provided by the German Federal Ministry of Education and Research (BMBF) through KfW and by the global health agency Unitaid as part of ACT-A. Additional support comes from the European & Developing Countries Clinical Trials Partnership (EDCTP) – under its second programme supported by the European Union with additional funding from the Swedish government -, the Starr International Foundation and the Stavros Niarchos Foundation (SNF).

Media contacts:

Charlotte Baker | bakerc@unitaid.who.int | +447904 460 181

Maggie Zander | zanderm@unitaid.who.int | +41 79 593 17 74

Unitaid statement regarding Ivermectin as a potential COVID-19 treatment

Geneva – Ivermectin, as well as other repurposed and new products, has been under evaluation in clinical trials as a potential treatment for COVID-19.

After updating the independent living network meta-analysis, the WHO Guidelines Development Group has updated the WHO Living Guidelines: Therapeutics and COVID-19 (today March 31).  In this updated version, WHO recommends not to use ivermectin in patients with COVID-19 except in the context of clinical trials based on very low certainty of evidence.

Unitaid, in collaboration with the University of Liverpool, has tracked the evidence available for ivermectin from randomised clinical studies from around the world, with various studies still to be completed.

In addition, to support the acquisition of the necessary remaining evidence as soon as possible, the ANTICOV consortium – coordinated by DNDi and partly funded by Unitaid – is preparing to add ivermectin in a combination therapy, as a new treatment arm to the clinical trial. This large platform trial aims to identify treatments that can be used to treat mild and moderate cases of COVID-19, preventing them from progressing to severe COVID-19, and is being conducted in 13 countries in Africa, nine of which are funded by Unitaid.”

Media contact:  

Hervé Verhoosel | +44 77 29 618 634 | verhooselh@unitaid.who.int

COVID-19 oxygen emergency impacting more than half a million people in low- and middle-income countries every day, as demand surges

  • More than half a million COVID-19 patients in LMICs estimated to need oxygen treatment every day.
  • New assessments show US$90 million immediate funding required to meet urgent need in up to 20 low- and middle-income countries (LMICs). Unitaid and Wellcome will make an immediate contribution of up to US$20 million in total for the emergency response.
  • COVID-19 Oxygen Emergency Taskforce brings together key organisations working on oxygen access under ACT-Accelerator Therapeutics pillar, as COVID-19 surges and preventable deaths occur
  • Taskforce partners will work together to measure oxygen demand, work with financing partners, and secure oxygen supplies and technical support for worst-affected countries 

Geneva – Since the start of the pandemic, affordable and sustainable access to oxygen has been a growing challenge in low- and middle-income countries.

COVID-19 has put huge pressure on health systems, with hospitals in many LMICs running out of oxygen, resulting in preventable deaths and families of hospitalised patients paying a premium for scarce oxygen supplies.

Oxygen is an essential medicine, and despite being vital for the effective treatment of hospitalised COVID-19 patients, access in LMICs is limited due to cost, infrastructure and logistical barriers. Health facilities often cannot access the oxygen they require, resulting in the unnecessary loss of lives.

Recognising the central importance of sustainable oxygen supply – alongside therapeutic products such as dexamethasone – for the treatment of COVID-19, the Access to COVID Tools Accelerator Therapeutics pillar (co-led by Unitaid and Wellcome), is taking a new role to coordinate and advocate for increased supply of oxygen, and, in partnership with a WHO-led consortium[1], is today announcing the launch of a COVID-19 Oxygen Emergency Taskforce.

It is estimated that more than half a million people in LMICs currently need 1.1 million cylinders of oxygen per day[2], with 25 countries currently reporting surges in demand, the majority in Africa. This supply was constrained prior to COVID-19 and has been exacerbated by the pandemic.

Dr Philippe Duneton, Executive Director of Unitaid, said: “This is a global emergency that needs a truly global response, both from international organisations and donors. Many of the countries seeing this demand struggled before the pandemic to meet their daily oxygen needs. Now it’s more vital than ever that we come together to build on the work that has already been done, with a firm commitment to helping the worst-affected countries as quickly as possible.”

The taskforce has determined an immediate funding need of US$90 million to address key challenges in oxygen access and delivery in up to 20 countries, including Malawi, Nigeria and Afghanistan. This first set of countries has been identified based on assessments coordinated by WHO’s Health Emergencies Programme, in order to match in-country need with potential financing, such as through the World Bank[3] and the Global Fund. Unitaid and Wellcome will make an immediate contribution of up to US$20 million in total for the emergency response. The urgent, short-term requirements of additional countries will be measured and costed in the coming weeks, with the overall funding need over the next 12 months estimated by ACT-A to be US$1.6 billion – a figure that will be regularly reviewed by the taskforce.

Dr Mike Ryan, Executive Director of the WHO Health Emergencies Programme, said: “Oxygen is life-saving and it is imperative to move faster to scale-up holistically with patient-centred, end-to-end solutions that improve clinical outcomes. WHO has been working through the Biomedical Consortium to bring the technical, clinical and procurement partners together with about US$80 million of biomedical equipment procured for low and middle-income countries. The Oxygen Taskforce will help drive oxygen scale-up through further innovation, financing and capacitation.”

Paul Schreier, Chief Operating Officer at Wellcome, said: “We have made critical advances in providing lifesaving clinical care and treatments to COVID-19 patients over the last year. The impact of the combination of oxygen and dexamethasone to treat severely ill patients has, in particular, been incredible. But global access to advances remains unequal. We need to urgently increase access to medical oxygen to ensure patients are benefiting regardless of where they live and ability to pay. International solidarity is the quickest – and only – way out of this pandemic. It is a public health, scientific, economic and moral imperative that all tools are made available globally.”

The taskforce brings together key organisations[4] that have been working to improve access to oxygen since the start of the pandemic including Unitaid, Wellcome, WHO, Unicef, the Global Fund, World Bank, the Clinton Health Access Initiative (CHAI), PATH, the Every Breath Counts coalition and Save the Children. Building on these efforts, partners will focus on four key objectives as a part of an emergency response plan: measuring acute and longer-term oxygen needs in LMICs; connecting countries to financing partners for their assessed oxygen requirements; and supporting the procurement and supply of oxygen, along with related products and services. Other areas in the scope of the taskforce include addressing the need for innovative market-shaping interventions, as well as reinforcing advocacy efforts to highlight the importance of oxygen access in the COVID-19 response.

Henrietta Fore, Executive Director of UNICEF, said: “Oxygen is a simple medical intervention that remains in short supply for far too many around the world. The COVID-19 pandemic has taken this acute shortage and made it a full-blown emergency. But addressing the oxygen gap will not only help with COVID-19 treatment in countries that are losing far too many saveable lives. It will also help to improve health systems and health outcomes beyond COVID-19 in the long term, including for the many newborns and children who require oxygen to survive.”

[1] As part of the UN COVID-19 Supply Chain System, a technical biomedical procurement consortium was set up under the coordination of WHO, including ALIMA, BMGF, IMC, MSF, UNDP, UNHCR, Unicef, UNOPS, USAID and WFP. Approximately US$150m of oxygen related biomedical products and consumables have been delivered to 149 countries over the last year.

[2]  https://www.path.org/programs/market-dynamics/covid-19-oxygen-needs-tracker

[3] Governments can apply for financing through the World Bank’s COVID-19 emergency health response.

[4] Partners joining the taskforce include Unitaid, Wellcome, WHO (and the broader biomedical consortium WHO coordinates), Unicef, The Global Fund, the World Bank, UNOPS, Save the Children, Every Breath Counts (coalition), CHAI and PATH.

Editor’s notes and background 

Even before COVID-19, pneumonia was the world’s biggest infectious killer of adults and children, claiming the lives of 2.5 million people in 2019. The pandemic has exacerbated this problem, particularly in ‘double-burden’ countries which are contending with high levels of pneumonia and COVID-19. As well as meeting the immediate needs of the pandemic, the taskforce would look to leverage gains in this area to help with long-term pneumonia control.

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Germany contributes €20 million to Unitaid’s vital work on COVID-19

Geneva – Unitaid welcomes a contribution of €20 million from Germany to advance work on COVID-19 treatments under the Access to COVID Tools Accelerator (ACT-A) initiative.

Germany is the third largest donor to the ACT Accelerator and has been a leading supporter of efforts to improve global health, with the government announcing a total funding package of €1.5 billion for tools to combat the COVID-19 pandemic.

This announcement comes as the ACT-Accelerator launches an updated strategy and investment case, with a focus on preparing low- and middle-income countries to roll out vaccines, treatments and tests, and stepping up efforts to find new therapeutics to treat COVID-19.

The funding from Germany will contribute to the realisation of key aspects of the new ACT-Accelerator Therapeutics Partnership strategy (co-led by Unitaid and Wellcome), including advancing research on new treatments for COVID-19, ensuring affordable supplies and country preparedness so that low- and middle-income countries are able to use treatments effectively, further allowing for the procurement of proven treatments, as and when they become available.

Unitaid Executive Director Dr Philippe Duneton said: “Unitaid welcomes this new collaboration with Germany, which will help ensure equitable access for all to promising COVID-19 treatments. Given the challenges posed by the emergence of new variants, it has never been more important to have the full set of tools to fight the pandemic, and effective treatments are an essential part of this mix.”

Media contact: Charlotte Baker | tel. +44 7904 460 181 | bakerc@unitaid.who.int

Unitaid welcomes the appointment of Dr. Ngozi Okonjo-Iweala to lead WTO

Geneva – Unitaid warmly welcomes the appointment of Dr. Ngozi Okonjo-Iweala as the new Director-General of the World Trade Organization (WTO).

“I congratulate Dr. Okonjo-Iweala for taking the leadership of the WTO at such a critical moment in the global fight against COVID-19,” said Unitaid’s Executive Director Dr Philippe Duneton. “With this choice, WTO Members have made history. Dr. Okonjo-Iweala’s experience and strong commitment to tackling the pandemic as the WHO Special Envoy for the ACT-Accelerator make her an invaluable asset to navigate the WTO through the COVID-19 crisis and shape its response to the economic and health challenges posed by the pandemic. I look forward to our collaboration in finding and developing innovative solutions to make sure that critical life-saving tools, vaccines, treatments and diagnostics, are made available quickly and equitably for all, to defeat the pandemic”.

Unitaid will continue to proactively engage with the private sector, governments, donors and civil society, to invest in the Medecines Patent Pool (MPP) and other mechanisms to accelerate access to health tools in low- and middle-income countries to bring COVID-19 and other diseases to an end.

With Dr. Okonjo-Iweala onboard as WTO’s new Director-General, and her long experience in economy, finance and development, we will continue to join efforts to collectively expand access to innovative treatment and care for all.

Media contact: Maggie Zander | +41 79 593 17 74 | zanderm@unitaid.who.int

Unitaid’s response to COVID-19 praised in UK government review

Geneva – Unitaid has received a high ‘A’ rating in its annual review from the UK Foreign, Commonwealth and Development Office (FCDO).

The UK’s annual review process assesses the effectiveness of all development projects supported by the UK government against a set of robust performance standards.

The report underscored the efficiency and effectiveness of Unitaid’s operating model, highlighting that “Unitaid continues to represent a strong value for money proposition” for UK investment.

Highlights from the report also included praise for Unitaid’s ‘proactive role in the response to COVID-19’ through its leadership in the ACT-Accelerator, commending the organisation’s ‘quick, decisive action and value-add in the areas of access to COVID-19 therapeutics and diagnostics, and health-system strengthening’.

Unitaid welcomes the outcome of this review and is focused on continuing to deliver impact from its investments, playing a lead role in equitable access for COVID-19 therapeutics and diagnostics and engaging with the global health community in the process of developing a new Strategy.

The full report can be read here.

Media contact: Charlotte Baker | tel. +44 7904 460 181 | bakerc@unitaid.who.int

Unitaid statement regarding Ivermectin as a potential COVID-19 treatment

Ivermectin, as well as other repurposed products, has been suggested as a potential treatment for COVID-19 based on preliminary promising evidence – further data is needed to support a definitive recommendation either for or against its use for COVID-19.

Unitaid has collaborated with the University of Liverpool to conduct the preliminary desk analysis of existing trials evaluating ivermectin in different countries of the world, in order to facilitate a review by WHO.

The preliminary analysis has incorporated data from randomised clinical studies that have been completed in Bangladesh, Egypt, Iran, India, Iraq, Lebanon, Pakistan, Turkey, Nigeria, Argentina, Mexico, and Spain.

In the coming weeks, results from additional trials in other countries are expected, and an in-depth analysis will be conducted by WHO to determine next steps, including the potential need for further targeted clinical studies.

Media contact: 

Hervé Verhoosel | +44 7729 618634 | verhooselh@unitaid.who.int

Cost of rapid COVID-19 tests halved as global investment ensures availability of high volumes for low- and middle-income countries

  • Technology transfer, scale up and automation of manufacturing capacity will enable over 250 million high-quality tests to be made available for low- and middle-income countries (LMICs) at a price of less than US$2.50 per test
  • A set of new agreements, the first of which with Premier Medical Corporation (PMC) of India, follow an open call for Expressions of Interest (EOI), launched last year by FIND and Unitaid on behalf of the Access to COVID-19 Tools (ACT) Accelerator, to drive equitable access to fit-for-purpose Ag RDTs for COVID-19

Geneva – The Foundation for Innovative New Diagnostics (FIND) and Unitaid, on behalf of the Access to COVID-19 Tools (ACT) Accelerator Diagnostics Pillar, announced today that the first contracts have been finalized, following an open call for Expressions of Interest (EOI) that was launched on 4 July 2020 to drive equitable access to fit-for-purpose antigen-detecting rapid diagnostic tests (Ag RDTs) for COVID-19.

The agreement announced today, with Premier Medical Corporation (PMC), headquartered in Sarigam Gujarat, India, is the first in a set of investments in R&D, including technology transfer and manufacturing scale up, that will be announced in the coming weeks.

With support from FIND and Unitaid, the company is expanding and automating manufacturing capacity so that Ag RDTs can be made available to low- and middle-income countries (LMICs) for less than US$2.50 per test (excluding transportation and potential duties). Achieving World Health Organization (WHO) Emergency Use Listing (EUL) is a key contractual condition. The investment will enable current production of 3 million COVID-19 tests per month to be scaled up to 10 million per month by Q3 2021. The expanded manufacturing capacity can also be used in future to make affordable tests for other infectious diseases, including another potential pandemic.

This and subsequent investments stemming from the EOI will support technology transfer and scale up of regional manufacturing capacity, ultimately to enable over 250 million low-cost, high-quality tests to be made available for LMICs. Further development that will enable nasal sampling (less invasive than current nasopharyngeal swabbing) and enhanced test performance is also being supported as part of this project.

Testing continues to play a critical role in the COVID-19 pandemic, enabling patient care as well as providing decision makers with vital data to inform test-trace-isolate strategies and lockdowns. Despite the introduction of two Ag RDTs in September 2020, testing capacity remains highly centralized in many countries, and often insufficient to meet the current demand.

This is especially true in LMICs, where fragile health systems and exclusive reliance on global supply chains have often left healthcare providers unable to access urgently needed tests. While high-income countries are now conducting 252 tests per 100,000 people each day, in LMICs the rate is 10 times lower, at just 24 tests per 100,000 people.[1] These issues arise from a lack of access to the laboratories needed for processing more complex molecular tests, and populations who often live far from health centres and need rapid results to avoid multiple journeys.

The ACT-Accelerator estimates that 500 million COVID-19 diagnostic tests are needed in LMICs during 2021, 75% of which must be deployed in decentralized settings (i.e. primary healthcare, community-level care, hospital triage). Ag RDTs are the primary diagnostic test for detection of active SARS-CoV-2 infection in decentralized settings where timely molecular testing is not available.

Dr Catharina Boehme, CEO of FIND, said: “Ensuring LMICs have access to low-cost, high-quality Ag RDTs is of vital importance in our work to make sure that everyone who needs a test for COVID-19 can get one. This open, transparent EOI process has spurred new partnerships that mean new tests can be scaled up fast and in the volumes needed to drive down costs.”

Dr Philippe Duneton, Executive Director of Unitaid, said: “Expanding access to rapid, high-quality diagnostics in LMICs, as part of a test and treat approach, is of crucial importance if we are to defeat this pandemic. The agreements we are announcing today are a vital part of that work, alongside our efforts in country preparedness, ensuring optimal conditions for these tests to be used on the ground.”

WHO Director-General, Dr Tedros Adhanom Ghebreyesus said: “Testing has been our compass in the fight against the pandemic and will continue to play a key role in gauging the effectiveness of vaccinations in communities. Today’s announcement brings new hope for the many countries that have flown blind in the face of the pandemic because they could not access or afford diagnostic tools. I urge the global community to keep supporting the ACT-Accelerator and bridge the funding gap of more than US$5.3 billion still needed for diagnostics.”

[1] Median values of 7-day rolling averages in each income group. Data correct as at 7 January 2021, www.finddx.org/covid-19/test-tracker

 Background notes

The EOI was launched on 4 July 2020 by FIND and Unitaid, on behalf of the Market Readiness Working Group of the ACT-Accelerator Diagnostics Pillar. It aims to accelerate supply and availability of quality-assured and regulatory-approved fit-for-purpose SARS-CoV-2 Ag RDTs that meet WHO criteria of quality, cost and accessibility. Interventions include facilitating regulatory approvals, increasing production capacity, addressing supply chain challenges, and strengthening local capacity for development and deployment of new tests within national testing strategies. Driving down prices to enable faster LMIC uptake is critical. Over 100 applications were received, with 34 selected for review by a panel of external experts.

About the ACT-Accelerator

The Access to COVID-19 Tools (ACT) Accelerator, is a new, ground-breaking global collaboration to accelerate the development production, and equitable access to COVID-19 tests, treatments, and vaccines. It was set up in response to a call from G20 leaders in March 2020 and launched by WHO, the European Commission, France and the Bill & Melinda Gates Foundation in April 2020. The ACT-Accelerator is not a decision-making body or a new organization, but works to speed up collaborative efforts among existing organizations to end the pandemic. It is a framework for collaboration that has been designed to bring key players around the table with the goal of ending the pandemic as quickly as possible through the accelerated development, equitable allocation, and scaled up delivery of tests, treatments and vaccines, thereby protecting health systems and restoring societies and economies in the near term. It draws on the experience of leading global health organizations which are tackling the world’s toughest health challenges, and who, by working together, are able to unlock new and more ambitious results against COVID-19. Its members share a commitment to ensure all people have access to all the tools needed to defeat COVID-19 and to work with unprecedented levels of partnership to achieve it. The ACT-Accelerator has four areas of work: diagnostics, therapeutics, vaccines and the health system connector. Cross-cutting all of these is the workstream on Access & Allocation.

The Diagnostics Pillar of the ACT-Accelerator is focused on ensuring that everyone who needs a test can get one. Workstreams span research and development, market readiness, procurement, and country preparedness. Achievements to date include laboratory trainings in partnership with Africa CDC in early February, and a suite of online courses deployed within weeks. Nearly 20 million tests have been procured with the Diagnostics Consortium, ensuring diagnostic access for LMICs and readiness for test-and-treat implementation in these countries. Independent evaluations of antibody tests are also being conducted, as high-quality antibody tests are essential to understand population immunity for future vaccine roll out.

Media contacts:

Unitaid

Hervé Verhoosel
Communications Lead
M: +44 77 29 618 634
verhooselh@unitaid.who.int

Charlotte Baker
Communications Officer
M: +44 7904 460 181
bakerc@unitaid.who.int

FIND

Sarah-Jane Loveday
Head of Communications
M: +41 (0) 79 431 62 44
media@finddx.org

For information on Unitaid’s response to COVID-19 please see https://unitaid.org/covid-19/#en

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