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In the middle of the second largest Ebola outbreak ever recorded, the search for a life-saving treatment is underway. A clinical trial of patients in Congo gathers evidence on experimental therapies to provide a proven option when the deadly virus will inevitably reappear.
The first clinical trial of several Ebola therapies, which began recruiting patients in November, will compare the effectiveness of three treatments with the antibody and an antiviral drug. A therapy briefly tested during the 2014-2016 outbreak in West Africa, the largest ever recorded, has already proved promising.
With the test data, however, "we can say, ideally, that this drug or this drug actually works, not just we think or hope that it will work," says Richard Davey, one of the lead investigators and the assistant clinical director of the US National Institute of Allergy and Infectious Diseases in Bethesda, Maryland.
Ebola causes serious illness, including fever, vomiting, diarrhea and bleeding. Mortality rates range from 25 to 90%, depending on the epidemic. During the current outbreak in Congo – the tenth and largest in the country since the discovery of the Ebola virus within its borders in 1976 – about 63% of infected people have died, or 510 of the 811 reported cases February 9th. The epidemic has begun According to the World Health Organization, August 1 has been difficult because of the security risks and armed conflicts in the region, as well as the public's distrust of it. regarding medical interventions.
28 days of treatment
The drug trial began in a treatment unit in the city of Beni, in northeastern Congo, with the intention of adding new units. Registered patients will receive one of four trials, as well as traditional supportive care, including fluids, electrolytes, and painkillers.
The researchers will compare mortality rates for each group of patients enrolled after 28 days of treatment to determine the effectiveness of each drug. The four treatments tested were studied in the animal. The three antibody treatments have been found safe for use in humans, while safety tests of the antiviral in humans are ongoing.
Antibody-based therapies "fundamentally stimulate the immune system to the immediate presence of antibodies directed against the virus," says Davey. One of these, called mAb114, was cloned from a sample of an Ebola survivor 11 years after the person's infection in 1995. This treatment targets a protein on the surface of the Ebola virus and somehow prevents its penetration into the cells. All macaques who received a lethal dose of Ebola and treated with mAb114 survived even when the drug had been administered five days after infection, researchers said in Science in 2016.
While mAb114 is composed of a single antibody, two others – REGN-EB3 and ZMapp – are cocktails each containing three different antibodies. In a study that evaluated different doses of REGN-EB3, some dosing regimens prevented death in all macaques infected with Ebola or in most of them, according to a 2018 study published in the Journal. of Infectious Diseases.
Hope in a dark situation
Meanwhile, ZMapp seemed to benefit some patients during a clinical trial conducted at the end of the outbreak in West Africa. Researchers reported in the New England Journal of Medicine in 2016 that eight of 36 patients receiving the drug and supportive care had died, compared to 13 out of 35 patients receiving supportive care only. Significant evidence that the drug works better than supportive care alone.
The only antibody-free treatment studied in this trial is an antiviral drug called remdesivir, or GS-5734, which seems to target a step in the virus's "user manual" to make copies of itself. The drug suppresses virus replication and, at certain doses, helps Ebola-infected macaques to survive, researchers said in Nature in 2016.
All of the therapies under study are already being used in this epidemic as part of WHO's "Compassionate Use" protocols. In Congolese treatment units that will participate in the clinical trial, patients will be randomized to receive one of the drugs with an equal number of patients in each group. If the trial does not enroll enough patients to achieve statistically significant results, it will remain open to patients in future outbreaks.
In the meantime, people who are not yet exposed to Ebola but are considered high risk in the Congo and surrounding countries receive an experimental vaccine called rVSV-ZEBOV to prevent infection. More than 73,000 people have received the preventive blow so far. Congo has vaccinated health workers, family members of patients and other contacts. Neighboring areas in Uganda and southern Sudan also vaccinate health workers and other at-risk individuals. Rwanda intends to do the same.
Mosoka Fallah, infectious disease epidemiologist of the National Institute of Public Health of Liberia, in Monrovia, said that "the only asset" of this epidemic is the availability of vaccine and drugs. He believes that the deployment of the vaccine and the treatments have prevented the epidemic from becoming much worse than it already is.
"Even if it's a dark situation, it's hopeful," says Fallah.
Read more
The facts about the terrible epidemic of Ebola in Congo
Scientists discover deadly Ebola virus for the first time in a West African bat
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