Inside the study for a remedy to fight Congo’s deadliest Ebola outbreak

More than 250 participants have been enrolled in a trial for a drug that could stop them from contracting Ebola in Congo , in what experts have described as a critical step to try to fight the deadliest outbreak of the disease in the Central African country.

The drug is targeted at Bundibugyo virus, which is responsible for the fast-moving outbreak and is without an approved vaccine or treatment. The trial began in July and is one of several studies launched to find some protection and another way of at least slowing the outbreak.

The Associated Press spoke this week to participants and doctors at the health center where the trial is taking place in the eastern province of Ituri, the epicenter of the outbreak. The participants include people who have been exposed to the disease in this outbreak, among them health workers and patients’ relatives.

At least 8,300 confirmed cases , including 4,000 deaths, have been recorded since this Ebola outbreak was declared in mid-May in eastern Congo. It has spread to seven provinces and continues to outpace efforts to track and slow it, authorities say.

The trial is testing Gilead’s experimental antiviral pill, called obeldesivir, which is given soon after suspected contact with the virus to prevent the disease from developing. That approach is called post-exposure prophylaxis, or PEP.

One participant in the trial known as EBO-PEP told AP that she enrolled in the study in August after her husband tested positive for Ebola. She says so far no one from her family developed symptoms.

She and other trial participants requested anonymity to protect their privacy due to the sensitive nature of the Ebola outbreak and the medical protocol involved.

“I realized that if I even touched my husband — and I did touch him, his vomit, everything — (it meant that) I was a direct contact. I could have also passed on this contagious disease. I could have been contaminated,” the participant said.

She said she knew of entire households which had become infected after a family member tested positive for Ebola. But so far no one from her family has developed symptoms, she says.

Ebola disease only spreads once symptoms begin. People exposed to infected patients have to wait to see if they get sick. Finding people at high risk of incubating the Bundibugyo virus — also known as contact tracing — has proved difficult in Congo.

Another participant said two of their family members had caught Ebola, and one of them had died. “This disease is killing. It’s better to take precautions,” he said.

The trial, coordinated by ALIMA, a medical nonprofit, aims to recruit nearly 1,000 adults or children over the age of 12 who have come into contact with a confirmed case within the last five days but have no symptoms. Half will get a placebo.

Participants are monitored in person every day for 21 days, with a final phone call after 42 days, according to Dr. Godefroid Basara, who is working on the trial.

ALIMA said that if trial participants begin to develop symptoms, they will immediately receive supportive treatment, which has been shown to be helpful when symptoms are caught early.

If the pill proves effective, it could help break the infection chain.

“It differs from a vaccine, which may take days or weeks to provide protection. It is also different from curative treatment because it is intended for people who are not yet showing symptoms,” ALIMA research coordinator Dr. Guilavogui Jean Paul Yassa said.

Dr. Jacques Zawadi, an investigating physician working with ALIMA at the trial center, said most participants are happy to take part in the study, but it had been challenging encouraging some people who live far from the center to sign up.

He said the study is sometimes disrupted when participants find out their family members have died from the disease.

“This is the biggest challenge we face. When a person is emotionally affected, it is not easy to reason with them and ensure they return to the study,” he said.

The trial partners also include Congo’s National Institute of Biomedical Research and the French institute ANRS Emerging Infectious Diseases.

As new vaccines are under development elsewhere, Congo started vaccinating health workers with the Ervebo vaccine which was effective during previous Ebola outbreaks caused by a different, more common virus. Authorities have said Ervebo could offer some protection against Bundibugyo, but whether the vaccine can actually prevent illness is still being studied.

On Thursday, humanitarian organization Doctors Without Borders said a staff member had tested positive for Ebola and was being evacuated to the Netherlands. In June, a humanitarian physician with ALIMA also tested positive after returning to France from one of the virus hot spots.

The World Health Organization has said the outbreak continues to outpace efforts to track and slow the spread, and is set to exceed West Africa’s regional outbreak between 2014 and 2016 — the deadliest on record — which killed 11,000 people.

超过 250 名参与者参加了一项药物试验，该药物可以阻止他们在刚果感染埃博拉病毒。专家称，这是为对抗这个中非国家最致命的埃博拉疫情而采取的关键一步。

这种药物针对的是邦迪布焦病毒，该病毒是此次疫情快速蔓延的罪魁祸首，目前尚无获批的疫苗或治疗方法。该试验于7月启动，是旨在寻找某种保护措施和减缓疫情传播速度的其他方法的多项研究之一。

美联社本周采访了疫情中心伊图里省一家医疗中心的参与者和医生，该中心正在进行一项临床试验。参与者包括此次疫情中接触过病毒的人员，其中包括医护人员和患者家属。

自5月中旬刚果（金）东部宣布爆发埃博拉疫情以来，已记录至少8300例确诊病例，其中包括4000例死亡病例。当局表示，疫情已蔓延至七个省份，且传播速度持续超出追踪和遏制工作的能力。

这项试验正在测试吉利德公司研发的实验性抗病毒药物奥贝地西韦（obeldesivir），该药在疑似接触病毒后尽快服用，以防止疾病发展。这种方法被称为暴露后预防（PEP）。

参与名为EBO-PEP试验的一名受试者告诉美联社，她的丈夫埃博拉病毒检测呈阳性后，她于8月份参加了这项研究。她说，到目前为止，她的家人中没有人出现症状。

由于埃博拉疫情的敏感性以及所涉及的医疗方案，她和其他试验参与者要求匿名以保护隐私。

“我意识到，即使我碰过我丈夫——而我的确碰过他，碰过他的呕吐物，所有的一切——（那就意味着）我是直接接触者。我也可能把这种传染病传染给他。我可能已经被感染了，”这位参与者说道。

她说，她知道有些家庭因为有家庭成员埃博拉病毒检测呈阳性而全部感染。但她说，到目前为止，她家还没有人出现症状。

埃博拉病毒只有在出现症状后才会传播。接触过感染者的人必须等待观察自己是否会发病。在刚果，寻找可能感染邦迪布焦病毒的高危人群（也称为接触者追踪）已被证明十分困难。

另一位参与者说，他家有两人感染了埃博拉病毒，其中一人已经去世。“这种疾病会致命。最好做好预防措施。”他说。

这项由医疗非营利组织ALIMA协调开展的试验，旨在招募近1000名12岁以上的成年人或儿童，他们在过去五天内曾与确诊病例有过接触，但无任何症状。其中一半人将接受安慰剂治疗。

据参与该试验的戈德弗罗伊德·巴萨拉博士称，参与者将接受为期 21 天的每日现场监测，并在 42 天后进行最后一次电话随访。

ALIMA表示，如果试验参与者开始出现症状，他们将立即接受支持性治疗，这已被证明在症状早期发现时很有帮助。

如果这种药丸被证明有效，它就能帮助切断感染链。

“它与疫苗不同，疫苗可能需要几天或几周才能提供保护。它也不同于治愈性治疗，因为它是针对尚未出现症状的人的，”ALIMA研究协调员吉拉沃吉·让·保罗·亚萨博士说。

在试验中心与 ALIMA 合作的调查医生 Jacques Zawadi 博士表示，大多数参与者都乐于参加这项研究，但鼓励一些居住在离中心较远的人报名参加却是一项挑战。

他说，当参与者得知他们的家人死于这种疾病时，这项研究有时会被打断。

他说：“这是我们面临的最大挑战。当一个人情绪受到影响时，很难与他们讲道理，并确保他们重返研究。”

试验合作伙伴还包括刚果国家生物医学研究所和法国新发传染病研究所 (ANRS)。

由于其他地区正在研发新的疫苗，刚果（金）开始为医务人员接种埃尔韦博疫苗。该疫苗在之前由另一种更常见的埃博拉病毒引起的疫情中曾发挥过有效作用。当局表示，埃尔韦博疫苗可能对邦迪布焦埃博拉病毒有一定的保护作用，但该疫苗是否真的能够预防疾病仍在研究中。

周四，人道主义组织“无国界医生”表示，一名工作人员埃博拉病毒检测呈阳性，已被撤离至荷兰。今年6月，一名来自ALIMA的人道主义医生从疫情热点地区返回法国后，埃博拉病毒检测结果也呈阳性。

世界卫生组织表示，疫情持续蔓延，超过了追踪和减缓疫情传播的努力，预计将超过 2014 年至 2016 年西非地区疫情的死亡人数——这是有记录以来最致命的疫情，造成 11000 人死亡。