Formal Title: Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled prophylaxis study (COPCOV)

Lay Title: Hydroxychloroquine for prevention of COVID-19

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, no proven treatment and no vaccine. As of writing, there are more than 200,000 deaths globally with 1,017 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 Wuhan 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 study to find out whether a drug called 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 also 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 will be conducted from four sites in Kenya; Kilifi, Mombasa, Nairobi and Kisumu. We aim to recruit up to 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.

What are the benefits and risks/costs of the study for those involved? 

There is a potential benefit of direct protection from corona virus infection if the drug works for those who are in the hydroxychloroquine arm. Individuals in the placebo arm may also benefit from indirect protection through decreased ability of the infection to spread.Risks related to hydroxychloroquine are very low.

How will the study benefit society?

The study may show a benefit of using hydroxychloroquine which would save many lives around the world, or alternatively may show hydroxychloroquine prophylaxis is ineffective so trials can move on to evaluate other possible interventions.

When does the study start and finish?

Following ethical and regulatory approval, the study is expected to take 18 months.

Study Title: The Chloroquine/hydroxychloroquin prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomized, placebo-controlled prophylaxis study (COPCOV)

Trial registration: NCT04303507 (PACTR registration pending)

Study design: Randomized double-blind, placebo controlled trial

Participants: Healthcare workers aged ≥18 years in a healthcare facility delivering direct care to patients with either proven or suspected COVID-19.

Planned sample size: 40, 000 worldwide, maximum of 1,600 in Kenya

Planned Study Period: 18 months; individual trial duration maximum 5 months

Objectives:

              Primary: To determine if hydroxychloroquine prophylaxis prevents symptomatic COVID-19 infection in healthcare workers

              Secondary:

              a) To determine if hydroxychloroquine prophylaxis attenuates COVID-19 infections

              b) To determine if hydroxychloroquine prophylaxis prevents asymptomatic infection with SARS-CoV-2, the virus that causes COVID-19

              c) To determine if hydroxychloroquine prophylaxis prevents all-cause symptomatic acute respiratory illnesses

              Tertiary

1. To characterize genetic and baseline biochemical markers associated with symptomatic COVID-19, respiratory illness and disease severity
2. To assess the impact of hydroxychloroquine prophylaxis on work and behavior during the pandemic
3. To perform health economic alalyses to assess the impact of hydroxychloroquine prophylaxis on costs and quality of life measures