In midst of outbreak, DRC begins first multidrug trial for Ebola treatments

Tedros Adhanom Ghebreyesus
Tedros Adhanom Ghebreyesus

A pioneering randomized control trial evaluating the effectiveness and safety of drugs used to treat patients infected with Ebola virus has begun in the Democratic Republic of the Congo, or DRC, according to WHO.

It is the first-ever multidrug trial for Ebola treatments, the agency said. The treatments were already being used but not evaluated during a deadly outbreak of the disease in the DRC.

“While our focus remains on bringing this outbreak to an end, the launch of the randomized control trial in DRC is an important step toward finally finding an Ebola treatment that will save lives,” WHO Director-General Tedros Adhanom Ghebreyesus, PhD, MSc, said in a statement.

As of Monday, the DRC’s 10th Ebola outbreak includes 419 cases — 365 confirmed and 47 probable — and 240 deaths, according to the country’s health ministry. So far during the outbreak, 35,958 people have received Merck’s experimental Ebola vaccine, the largest use of an Ebola vaccine in history. Additionally, several investigational treatments have been used to treat more than 160 infected patients, according to WHO.

“Until now, patients have been treated under a compassionate use protocol, with drugs that showed promise and had a good safety profile in laboratory conditions,” Tedros said. “The giant step DRC is taking now will bring clarity about what works best and [will] save many lives in years to come. We hope to one day say that the death and suffering from Ebola is behind us.”

The experimental treatments available in the DRC include ZMapp (Mapp Biopharmaceutical), a cocktail of three antibodies that was credited with helping cure patients in the 2014-2016 West African epidemic; mAb 114, a monoclonal antibody developed by the NIH that uses the antibodies of Ebola survivors to neutralize the virus; remdesivir (Gilead Sciences) and favipiravir (Toyama), which are experimental antivirals with activity against filovirus infections; and REGN3450, REGN3471 and REGN3479 (Regeneron), three human IgG1 monoclonal antibodies directed against three different epitopes on Ebola virus glycoprotein.

Patients who already received investigational treatments during the outbreak received them under an ethical framework developed by WHO called the Monitored Emergency Use of Unregistered and Investigational Interventions. The protocol was not designed to evaluate the drugs. However, now that protocols for trials are in place, patients will be randomly assigned treatments under the new protocols in facilities where the trial has begun, WHO said. In places where it has not yet started, patients will continue to be treated under the compassionate use provision until the trial begins there.

“Our country is struck with Ebola outbreaks too often, which also means we have unique expertise in combating it,” DRC health minister Oly Ilunga Kalenga, MD, PhD, said in a statement. “These trials will contribute to building that knowledge, while we continue to respond on every front to bring the current outbreak to an end.” – by Caitlyn Stulpin

Disclosures: The authors report no relevant financial disclosures.

Tedros Adhanom Ghebreyesus
Tedros Adhanom Ghebreyesus

A pioneering randomized control trial evaluating the effectiveness and safety of drugs used to treat patients infected with Ebola virus has begun in the Democratic Republic of the Congo, or DRC, according to WHO.

It is the first-ever multidrug trial for Ebola treatments, the agency said. The treatments were already being used but not evaluated during a deadly outbreak of the disease in the DRC.

“While our focus remains on bringing this outbreak to an end, the launch of the randomized control trial in DRC is an important step toward finally finding an Ebola treatment that will save lives,” WHO Director-General Tedros Adhanom Ghebreyesus, PhD, MSc, said in a statement.

As of Monday, the DRC’s 10th Ebola outbreak includes 419 cases — 365 confirmed and 47 probable — and 240 deaths, according to the country’s health ministry. So far during the outbreak, 35,958 people have received Merck’s experimental Ebola vaccine, the largest use of an Ebola vaccine in history. Additionally, several investigational treatments have been used to treat more than 160 infected patients, according to WHO.

“Until now, patients have been treated under a compassionate use protocol, with drugs that showed promise and had a good safety profile in laboratory conditions,” Tedros said. “The giant step DRC is taking now will bring clarity about what works best and [will] save many lives in years to come. We hope to one day say that the death and suffering from Ebola is behind us.”

The experimental treatments available in the DRC include ZMapp (Mapp Biopharmaceutical), a cocktail of three antibodies that was credited with helping cure patients in the 2014-2016 West African epidemic; mAb 114, a monoclonal antibody developed by the NIH that uses the antibodies of Ebola survivors to neutralize the virus; remdesivir (Gilead Sciences) and favipiravir (Toyama), which are experimental antivirals with activity against filovirus infections; and REGN3450, REGN3471 and REGN3479 (Regeneron), three human IgG1 monoclonal antibodies directed against three different epitopes on Ebola virus glycoprotein.

Patients who already received investigational treatments during the outbreak received them under an ethical framework developed by WHO called the Monitored Emergency Use of Unregistered and Investigational Interventions. The protocol was not designed to evaluate the drugs. However, now that protocols for trials are in place, patients will be randomly assigned treatments under the new protocols in facilities where the trial has begun, WHO said. In places where it has not yet started, patients will continue to be treated under the compassionate use provision until the trial begins there.

“Our country is struck with Ebola outbreaks too often, which also means we have unique expertise in combating it,” DRC health minister Oly Ilunga Kalenga, MD, PhD, said in a statement. “These trials will contribute to building that knowledge, while we continue to respond on every front to bring the current outbreak to an end.” – by Caitlyn Stulpin

Disclosures: The authors report no relevant financial disclosures.

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