First patients enrolled in record-breaking Ebola treatment trial in DRC | Global health

There is no approved drug to help medical teams struggling to save lives during the Ebola outbreak in the Democratic Republic of Congo; But those hopes could change within months as the first patients enroll in a treatment trial.

The scientists said it was a record pace to set up and launch such a study, with patients enrolled just six weeks into the study. Declaring the outbreak a public health emergency It was made a matter of international concern by the World Health Organization (WHO) on May 17.

However, in Bunia, the capital of Ituri province, where the virus is rampant, people are impatient.

“I hope these drug trials progress quickly,” said Neema Haba, a banana seller and mother of three. “Financially, we are coming to the brink due to this pandemic and nothing is going well. We are having a hard time providing for our children.”

As of July 9There have been 1,792 confirmed cases and 625 deaths caused by the Bundibugyo strain of the virus, for which there is no vaccine or approved treatment. Still “in expansion phase“, according to WHO.

The response relies on basic techniques such as identifying cases, isolating them for care, and tracking and monitoring people they have been in contact with.

Latest figures show around 75 per cent of known contacts have been traced, but efforts are hampered by low trust in authorities and a highly mobile population. Some front-line workers also stopped working this week to protest the lack of pay.

The bodies of Ebola victims are highly contagious and must be buried safely by properly trained professional teams. Ovide Maliabo, a driver for one of the teams in Rwampara, a mining town in Ituri, said the work was dangerous in the face of community mistrust and that he and his colleagues “didn’t see any point in risking our lives”.

“We narrowly escaped being lynched at one point,” he said. “It’s a shame we’re not financially supported.”

Bahati John, the head of the team, said that he lost a tooth as a result of an attack by local people.

“Honestly, since we started working on May 15, we have not seen a single penny, despite all the insults we have had to endure,” he said. “We are the breadwinners for our families, and our families are suffering.”

DRC officials He said the payments were made However, it is unclear whether activities are fully continuing. They said the closure of the local airport in Bunia hindered the response, including blocking the supply of banknotes.

Hopes of reversing the situation now rest on scientists searching for effective drugs.

Partners treatment trial opened with two drugs on its books – remdesivir and MBP134. Patients will be randomized to receive medication, a combination of the two, or simply standard supportive care.

Remdesivir is an antiviral produced by the pharmaceutical company Gilead Sciences; MBP134 is a monoclonal antibody developed by Mapp Biopharmaceutical that contains two specially designed immune proteins that recognize and neutralize the virus.

Both are given intravenously; MBP134 is given as a one-time infusion and remdesivir is given as a 10-day intravenous treatment.

“These two drugs have actually been proven to work against Bundibugyo virus in animal models,” said Prof Laurens Liesenborghs of the Antwerp Institute of Tropical Medicine, who worked on the trial in Ituri.

“They showed great efficacy, but now we need to test it in humans. What we basically want to see is whether they can actually reduce mortality.”

Bundibugyo has a lower mortality rate than the Ebola strain in Zaire that caused most previous outbreaks, but still kills about a third of those infected.

Researchers are watching carefully to see if there are any differences in death rates between groups given the experimental drug and groups receiving standard care. “Any improvement is good,” Liesenborghs said. “But it needs to be determined statistically, so we need to see a significant decrease.”

In trials examining the effect of monoclonal antibodies on cases of Ebola caused by the Zaire strain, they reduced death rates from 50% to 35%, he said. “I hope we see something of this magnitude.”

The design of the trial allows for the addition of other potential treatments if they become available. Liesenborghs said 700 to 1,000 patients would probably need to be enrolled for results. “We have opened one site, hopefully we will open additional sites very quickly, but it will still take several months depending on the course of the epidemic.”

WHO officials said enough remdesivir and MBP134 were donated by Gilead and the U.S. government, respectively, to enroll 1,200 patients. It was stated that WHO is in negotiations to ensure that sufficient supplies are provided after the trial if it is proven to be safe and effective.

Patients of all ages, including pregnant and breastfeeding women who are usually excluded from medical research, can participate in the study.

“We always think about risk-benefit,” says Liesenborghs. “The benefit here is potentially very high because you are providing a potentially life-saving treatment to someone who has a very high chance of dying.”

He added that Ebola caused miscarriages, but that tests on the drugs on animals showed no signs of risk for pregnancy.

“It’s great that we managed to get started so quickly,” says Prof Amanda Rojek, Partners’ international principal investigator from Oxford University.

He said strong scientific leadership in the Democratic Republic of Congo, which has hosted large trials during previous outbreaks of other diseases such as Ebola and mpox, is vital.

“If we look back at West Africa [an Ebola outbreak in 2014-16 that saw more than 28,000 cases and 11,000 deaths]It took us more than a year to start clinical trials, we are proud of the team led by INRB. [the DRC’s National Biomedical Research Institute] “We managed to achieve this in about six weeks since the outbreak was first announced.”

Just like the Healing During Covid experiment run by the Oxford group, the focus was on keeping the experiment as simple as possible, Rojek said.

Partners is sponsored by the WHO and funded by the Wellcome Trust, FCDO and UKRI.

Prof Yap Boum, head of emergency response at continental health watchdog Africa CDC, warned the danger was not over but added: “What limits the epidemic is our capacity to provide care, our surveillance capacity and our ability to isolate people. These trials will give us access to treatment and when we treat people it also sends a message to society.”

Another trial will begin this week to see whether a drug called obeldesivir can stop the disease from developing in people who have been in contact with cases of Bundibugyo.

The Africa CDC said about $18 million is needed to keep the trial going, and $6 million has been pledged to date.