Formal Title: Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled prophylaxis study (COPCOV)
What is the problem/background?
Coronavirus disease (COVID-19), which is caused by the virus known as SARS-CoV-2, was first reported in Wuhan China in December 2019 and has so far affected over 2 million people globally and has been declared a global pandemic by the World Health Organisation (WHO).
There is no proven effective prophylaxis and no vaccine. As of 23 November 2020, there are more than 1.4 million deaths globally with 49,728 in Africa. We are in a race against time to find effective treatments and preventive measures as the pandemic grows.
There is major concern that COVID-19 could devastate countries with limited capacity for testing and case isolation and overwhelm their fragile healthcare systems. The high risk to healthcare workers, as seen with SARS-CoV previously, and now in many countries with COVID-19, could be a major threat to healthcare operations overall.
People who look after patients with COVID-19 infections are at increased risk of infection. There is an urgent need to identify drugs which can prevent the spread of infection but also that prevent high-risk groups, like those working in healthcare facilities, from getting the infection, so they can continue to care for patients and protect their families.
What questions are we trying to answer?
We are conducting a clinical trial to find out whether hydroxychloroquine may prevent development of coronavirus illness. Chloroquine, the medicine very similar to hydroxychloroquine, was used very widely for the prevention and treatment of malaria for over 50 years and to treat rheumatoid arthritis. People have taken it for many years at a time. It is considered very safe, and it may have effects against the virus.
We would also like to find out if hydroxychloroquine lessens the symptoms for those who do get corona virus infection while taking it.
Where is the study taking place, how many people does it involve and how are they selected?
The study is being conducted in multiple countries in Asia, Europe and Africa. We hope to recruit up to 40,000 health care workers worldwide.
There are currently four study sites in Kenya; Kilifi, Mombasa, Nairobi, and Kisumu. We aim to recruit a minimum of 800 and a maximum of 1,600 participants across all sites.
We will enroll health care workers who are at high risk of exposure to SARS-CoV-2 infection.
What does the study involve for those who are in it?
Participants will answer some questions about their medical history, provide 25 ml of blood for testing, take study tablets (hydroxychloroquine or placebo) and record temperature and respiratory symptoms via mobile phone.
Participants will take the study tablets for 90 days. They will be requested to come to the study clinic on days 30,60 and 90, plus a final visit being conducted at 5 months.
Those reporting respiratory symptoms during the course of the study will have nasal and throat swabs collected for testing for the presence of respiratory viruses.