Kenya is one of two African countries that have started clinical trials for a drug that might be the cure to coronavirus that has caused thousands of deaths globally in addition to an economic meltdown.
The study whose results are expected in three months’ time will evaluate the efficacy and safety of Roche’s medicine Actemra (tocilizumab) in the treatment of Covid-19 associated pneumonia in hospitalised patients was initiated by Genentech, a member of the Roche Group, in the United States in May 2020. The trial has now expanded to other sites in South Africa, Kenya, Brazil, Mexico and Peru.
Ten patients have already been enrolled at the Clinical Research Unit of the Aga Khan University Hospital, Nairobi.
“Our people in Roche are working day and night with the aim of developing, manufacturing and supplying key tests and medicines where they are needed most. We are so glad to see the first Kenyan patients put on the EMPACTA trial,” said Dr Beatrice Nyawira, Medical Director, Roche Kenya Ltd.
“Disparities and lack of diversity in medical research hold the global community back, and Roche Kenya is proud to help close this gap.”
How it will work
The drug is expected to work on the body’s immune system by inhibiting interleukin-6 receptors to prevent pneumonia that has been characteristic of patients infected with Covid-19.
When one gets the virus, it triggers an immune reaction in the lungs whose cells produce a substance called Interleukin-6 (IL-6) that tries to kill the virus. In the event of an overreaction, this ‘friendly fire’ in the lungs causes acute respiratory distress (ARDS), and one presents with difficulty in breathing, needing supplemental oxygen.
“We think the culprit for the ARDS is IL-6, so this study is giving anti-IL-6 to patients with Covid-19 relates pneumonia before they get into the ventilator,” Prof. Mansoor Saleh, Director of the Clinical Research and Oncology units at AKUHN explained.
The drug, tocilizumab, which is already in use in cancer treatment and in rheumatology for rheumatoid arthritis is being repurposed in this Phase III clinical trial with the hope that it will block this part of the immune system.
The primary endpoint is to find out how many participants require mechanical ventilation by day 28. Additionally, the time to clinical failure which is defined as the time to mechanical ventilation, ICU admission, death or withdrawal (whichever occurs first) will be observed.
“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 our patients here,” said Dr Reena Shah, Associate Professor of Medicine in Infectious Diseases, and the Principal Investigator of the study in Kenya.
“This is where we contribute knowledge and experience about our capability and the outcome of our patients to the international community.”
The mortality rate by day 28 and time to hospital discharge or “ready for discharge” will also be analysed in the targeted 375 patients globally.
Only Covid-19 patients who on CT Scan show evidence of Covid-19 pneumonia and are in need of oxygen will be eligible to participate.
“Two of the patients will get the drug, and one patient will get the placebo but all of them will get the best of care, after which the outcomes will be compared.”
Kenyan trials
Kenya aims to recruit 60 patients in four weeks’ time into this double-blind placebo-controlled study. Here, some patients will receive the drug and others a placebo. Neither the patients themselves nor the doctors managing them will know who is on the drug and who is on the placebo.
“We want to get that middle ground of patients who are not too sick but maybe on their way to the ventilator so that we can protect them,” Prof. Mansoor explains.
According to Prof. Mansoor, the study was necessary for Africa because what works in North America may not work in Africa due to the unique environment in Africa, something that has allowed them to have unique inclusion criteria for participants.
Patients are given at least 24 hours to consider consenting into the study whose research results may change the course of the pandemic, which has claimed over 230 people in Kenya.
From its existing usage, the drug has no long term side effects but may cause a drop in blood pressure and shortness of breath while being administered and in the long term, in a few weeks’ time, it may cause immunosuppression, exposing the patients to other opportunistic infections.
80 per cent of patients on this drug will experience minimal or no side effects, and so far, Prof. Mansoor says that the patients enrolled at his Clinical Research Unit have not experienced any of these known side effects.
“Compared to Covid19 whose side effects are near death, intubation and ventilation, the side effects of this drug are minimal.”
The supply of the drug is not expected to be a challenge because of its existing use for other indications. Prof. Mansoor hopes that there will be a compassionate protocol for it, to allow as many eligible people as possible to benefit, should it be shown to stop the progression of severe disease in Covid-19 pneumonia.
“This is the first clinical trial in Aga Khan and I was surprised by the fact that patients were willing to participate, stating that even if it doesn’t help them as individuals, it will help the doctors learn something that may help others.” He concludes.
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