The Aga Khan University Hospital, in partnership with Roche, has launched a study to determine whether the pharmaceutical giant’s rheumatoid arthritis drug can be used to treat Covid-19 patients.
The performance of the drug known as Actemra will be studied in 11 patients in the clinical trial. Clinical trials are experiments to determine the efficacy of a drug in managing a patient’s condition.
Developed and sold by Roche, Actemra (tocilizumab) is an injectable drug for adults with moderate to severe active rheumatoid arthritis who have not responded satisfactorily to other anti-rheumatic drugs.
“This is a watershed moment for Kenya and us at the Aga Khan University Hospital, Nairobi, that we can participate in an international clinical trial that is testing the effectiveness of this novel drug on patients here,” said Dr Reena Shah, associate professor of medicine in infectious diseases and the principal investigator of the study in Kenya.
The 11 patients are part of a global trial dubbed Empacta (Evaluating Minority Patients with Actemra) study, a Phase III trial seeking to evaluate the safety and efficacy of the drug in Covid-19 patients hospitalised with pneumonia.
The first patient was treated on May 14 in New York, and the goal is to enrol about 375 patients at 40 sites across the United States. The primary endpoint is to reduce the number of days patients on mechanical ventilation. The study also seeks to cut back on the cases of death as well as ICU admission.
In international studies, the anti-inflammatory drug has failed in a coronavirus trial. In an Italian study, it did not help patients with early-stage Covid-19 pneumonia, the latest instance in which an anti-inflammatory drug failed a coronavirus trial. The trial, which had 126 patients — about a third of the intended number — was stopped early after an analysis raised doubts about its effectiveness.
In Kenya, the Ministry of Health said, the trial was based on a “recent finding by a team of clinical researchers at the University of Michigan that demonstrated that the drug prevented death by 45 per cent in a controlled study of 154 patients with severe Covid-19 illness requiring mechanical ventilation.
“The Ministry lends its support to the global trial... being conducted at the Aga Khan University Hospital here in Kenya as one of the study sites. We commend our private sector partners, the Aga Khan University Hospital and Roche Kenya in bringing this study to Kenya,” said Health Chief Administrative Secretary Rashid Aman.
According to the Swiss drug maker’s subsidiary, Genentech, Inc., the Empacta study was launched to serve minority populations like African Americans and Hispanics in the US after it was observed that the commonly-prescribed inhaled medication worked in European American and Mexican children, but was less effective in African American and Puerto Rican children.
“Disparities and lack of diversity in medical research hold the global community back, and Roche Kenya is proud to help close this gap. We are so glad to see the first Kenyan patients start on the Empacta trial,” said Dr Beatrice Nyawira, medical director at Roche.