UM leads clinical trials for Tocilizumab in Covid-19 treatment

Monday Apr 13th, 2020
By
By Rayyan Rafidi

Malaysia is embarking on a clinical study to evaluate the drug Tocilizumab for the treatment of severe cases of Covid-19.

Led by Universiti Malaya Faculty of Medicine dean Professor Datuk Dr Adeeba Kamarulzaman, the trial is underway at Universiti Malaya Medical Centre (UMMC), together with three public hospitals: Sungai Buloh Hospital, Kuala Lumpur Hospital and Tuanku Jaafar Hospital, Seremban.

Sold by its trade name Actemra, Tocilizumab has been used for years in the treatment of rheumatoid arthritis, giant cell arteritis and conditions involving excessive inflammation.

In a statement, Universiti Malaya said the study aims to compare the effectiveness of intravenous Tocilizumab in comparison to high-dose corticosteroids in approximately 300 Covid-19 patients who develop severe cases of the disease.

“The group of patients will be treated with either a high dose of corticosteroids or Tocilizumab, which are known to inhibit inflammation, as soon as there are clinical and laboratory markers of deterioration,” said Dr Adeeba.

An infectious diseases specialist with extensive experience in leading prevention, treatment and research on viruses such as HIV and Nipah, she is also an adjunct associate professor at Yale University, the United States.

“We are grateful for the Health Ministry’s participation in this joint study that has the potential to save many lives and contribute to the urgent search for the best treatment for patients with Covid-19, especially for those with severe illness.

“We know that approximately 80 per cent of Covid-19 patients have mild to moderate symptoms and will recover, however, 15 per cent progress to severe disease and another five per cent will develop critical illness, with death occurring in between one to three per cent of patients.”

Clinicians are gaining better understanding of the patients in the five per cent category.

“After about one or two weeks, the infected individuals will develop signs and symptoms of a cytokine storm that leads to respiratory failure and the need for mechanical ventilation.”

A cytokine storm occurs when the immune system continues to release cytokines in an uncontrolled manner, long after the infection has been overcome.

“Ironically, it is their own immune response to the virus that kills them. We need to figure out how to safely turn off the overactive immune response as soon as it begins.

“There is growing evidence that a specific cytokine, interleukin-6 (IL-6) is a critical component of the Covid-19 cytokine storm. Blocking IL-6 may stop the progression of the disease into its most critical stage.
This is where Tocilizumab, a drug specifically designed to block the negative effects of IL-6, exerts its actions.”

According to Dr Adeeba, Covid-19 patients who develop the cytokine storm syndrome at UMMC have shown encouraging results after Tocilizumab use.

“Out of eight severely ill patients who received the drug, we managed to prevent six from being ventilated and they are now doing well. This is a big deal considering the rate of deterioration of patients in China and Italy.

“In the other two patients, Tocilizumab did not work as well, as they were already very ill when the treatment was administered,” she said, adding that it was a missed window of opportunity.

Clinicians from Yale University will be joining Malaysian researchers in this study. Professor Rick Altice, Dr Christina Price and Dr Maricar Malinis have used Tocilizumab in treating Covid-19 patients on the brink of developing cytokine storms.

Sungai Buloh Hospital lead clinician Dr Suresh Kumar said: “While we are excited about the prospects of Tocilizumab preventing Covid-19 deaths, we want to know the ideal time to start the treatment and also to carefully monitor for any side effects among Malaysian patients.”

To date, RM450,000 has been raised by a small group of private donors for this study.

“We hope to raise a total of RM1.5 million for this clinical trial which can help to save lives in our fight against Covid-19. We are also grateful for the donation of Tocilizumab by Roche Malaysia that enabled us to treat the first few patients successfully,” said Dr Adeeba, adding that the study will run for a period of six months.

Members of the public can contribute to the fund by contacting Dr Adeeba at adeeba@ummc.edu.my

In an earlier report by the New Straits Times, Health director-general Datuk Dr Noor Hisham Abdullah said he hopes the research on Tocilizumab will help the ministry contain the pandemic.

"What is important is that we look at how the research is being conducted at four hospitals, if I am not mistaken, and we hope they comply with the standard operating procedures (SOPs) and the procedures for conducting the investigation," he said.

Earlier, he said three drugs, namely, Chloroquine, Hydroxychloroquine and the existing Lopinavir/Ritonavir combination which were used by the ministry to treat other diseases, were found to be effective in treating Covid-19 patients.