China is rushing a flurry of patient studies to identify the most effective life-saving treatments for people sickened by the novel coronavirus.
Some 77 clinical trials targeting the pneumonia-causing virus have been registered in China since Jan. 23, according to data compiled by Bloomberg. The disease, known as Covid-19, has infected at least 45,000 people, killing more than 1,110 mostly in China since it emerged in the city of Wuhan in late 2019 and spread to two dozen countries.
The trials range from the high-profile study of Gilead Sciences Inc.’s experimental antiviral drug remdesivir and AbbVie Inc.’s HIV pill Kaletra, to tests of traditional Chinese herbal medicines and whether the sport of shadowboxing may aid recovery. While the sheer size of the research effort is noteworthy, the ability to scientifically and methodically discern ways to treat and prevent infections caused by a novel pathogen in the middle of an outbreak is unprecedented.
“The role that research can play is often very contentious, whether we need to respond to an outbreak or whether we can actually take the time to research interventions,” said Anne Schuchat, principal deputy director of the U.S. Centers for Disease Control and Prevention. “It’s really important for us to be able to do both.”
“The pace of research can keep up sometimes and really needs to be not an afterthought, because we don’t know how long some of these new emerging infections will persist,” she said, noting that scientific accuracy and research quality remain critical.
Much of the research effort has been guided by the World Health Organization’s R&D Blueprint that enables the rapid activation of research studies during epidemics.
Chinese regulators have been streamlining bureaucracies to cut the time it takes to approve drug trials and win approvals, ensuring that patients can get cutting-edge medicines fast and, in some cases, even before patients in developed countries.
“Optimistically, some of the trials could have an early readout in three to four weeks,” said Ding Sheng, dean of Tsinghua University’s School of Pharmaceutical Sciences. If trials meet their key objectives, “conditional approval could be considered, given the current outbreak situation,” he said.
Some studies, including the one testing remdesivir, require regulatory approval from the National Medical Products Administration, while others are initiated by doctors and can proceed after hospital ethics committees have given their consent.It is important to start studies while the virus is circulating widely so researchers can determine relatively quickly which medicines are most effective. The large number of patients being diagnosed means that studies may be conducted fast, with full enrollment of antiviral drug trials occurring in just six months, said Soumya Swaminathan, the WHO’s chief scientist.
Efforts to develop drugs for Ebola and the coronaviruses that caused SARS and MERS ran into difficulty because of waning cases. Complicating the process is the potential that an outbreak may abate before a vaccine or treatment is ready for use, diminishing its value.
Gilead’s experimental drug remdesivir, which was developed to fight Ebola, but has shown some signs of potency against SARS and MERS, is being tested at a hospital in Wuhan after a patient getting it in the U.S. appeared to respond.
Some 761 patients are expected to be enrolled in the trial, 66% of whom will be dosed with the drug. The remainder will receive standard treatment and placebo, according to state-run news agency Xinhua.
While the drug’s effectiveness against the new coronavirus is still being investigated, scientists in China who tested it in labs filed an application to patent its use against the new 2019-nCoV coronavirus as early as Jan. 21. The move was seen as an effort by China to gain some bargaining power as it negotiates license fees with Gilead in the event that clinical trials prove remdesivir works in patients.
China’s National Health Commission recommends AbbVie’s Kaletra be used as part of antiviral treatment for Covid-19 cases even while it plans to study the efficacy of the HIV medicine alongside antivirals such as Roche Holding AG’s Xofluza, and Avigan, an anti-influenza medication developed by Fujifilm Holdings Corp. and Toyama Chemical Co.
Traditional Chinese remedies are also being explored for their virus-fighting potential. Guangdong Province Traditional Chinese Medicine Hospital is conducting observational studies to check the efficacy of two different concoctions of Chinese herbal medicines: one for infected patients and the other for those suspected of having the infection, said Liu Yuntao, who applied to conduct the trials. Further studies may be done if they appear to be effective, she said.
It’s important to ensure clinical studies are of high quality and generate meaningful results, WHO’s Swaminathan said.
“As long as the studies are done well, well-designed to give the right answer, there may be products which can be tested as adjunct therapies, for example, along with anti-retrovirals,” she said. “I would like to see that they’re tested in good clinical trial protocols.”
Guangdong’s drug regulator approved the use of an herbal medicine, dubbed “Pneumonia Formula 1,” across 30 hospitals. It was designated for treating pneumonia caused by the virus after more than half of the 50 patients who took it said symptoms such as coughing, throat pain and weakness resolved, and all of them no longer had fever, state media reported.