Virus drug trials begin at Nairobi’s Aga Khan hospital

Kenya is one of two African countries that have started Clinical trials on a drug that might be the cure for Covid-19.

The trials, whose results are expected in three months time, will evaluate the efficacy and safety of Actemra (tocilizumab) in the treatment of a pneumonia linked to Covid-19 in hospitalised patients.

The drug is manufactured by Roche, a multinational healthcare company.  

The trials were initiated by Genentech, a member of the Roche Group, in the United States in May 2020, but have now been 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.

Day and night

“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 start on the EMPACTA trial,” said Beatrice Nyawira, medical director, Roche Kenya Ltd.

“Disparities and lack of diversity in medical research holds the global community back, and Roche Kenya is proud to help close this gap,” said Dr Nyawira.

The drug is expected to work on the body’s immune system by inhibiting Interluekin-6 receptors to prevent the pneumonia that affects patients infected with Covid-19.

Coronavirus 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 causes acute respiratory distress (ARDS), characterised by difficulties in breathing.

“We think the culprit for the ARDS is IL-6, so this study is giving anti-IL-6 to patients with Covid pneumonia before they get into the ventilator,” said Mansoor Saleh, director of the clinical research and Oncology units at the Aga Khan University Hospital, Nairobi.

The drug, tocilizumab, is already in use in cancer and arthritis treatment.

The primary endpoint is to find out how many participants will 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,” said 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,” said Dr Shah.

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 show evidence of Covid-19 pneumonia on CT Scan and are in need of oxygen will be eligible to participate.

Kenya aims to recruit 60 patients in four weeks for the trials in which some patients will receive the drug and others a placebo - a substance that resembles the drug but contains no active drug.

Neither the patients 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 may be on their way to the ventilator so that we can protect them,” explained Prof Saleh.

Unique criteria

According to Saleh, the study was necessary because what works in North America may not work in Africa. This has allowed Kenyan trials to have unique inclusion criteria for participants. Patients are given at least 24 hours to consider consenting to the study whose research results may change the course of the pandemic.

From its existing usage, the drug has no long term side effects but may cause a drop in blood pressure and shortness of breath. Within a few weeks, the drug may suppress immunity, exposing the patients to other opportunistic infections. Up to 80 per cent of patients on this drug experience minimal or no side effects.

“Compared to Covid-19 whose side effects is near death, insertion of tubes and ventilation, the side effects of this drug are minimal,” said Saleh.

He hopes that there will be a compassionate protocol for the drug to allow as many eligible people as possible to benefit, should it be shown to stop the progression of Covid-19 pneumonia.

“This is the first clinical trial at Aga Khan Hospital Nairobi, 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 said.

Commenting on the trials, Dr Rashid Aman, Health ministry’s Chief Administrative Secretary lauded the private sector for its efforts in getting a solution to the pandemic.

“The merit of this ongoing trial has recently been validated by recent findings by a team of clinical researchers at the University of Michigan that demonstrated that tocilizumab was associated with a 45 per cent reduction in the hazard of death,” he said.