China has announced it will immediately commence clinical trials on an experimental drug, remdesivir, in hopes of finding an effective treatment for the novel coronavirus that has killed over 360 people and infected another 17,000 since mid-December.
The trial, which begins Monday and runs through April 27, will take place in the central city of Wuhan and include a total of 270 novel coronavirus patients, Sixth Tone’s sister publication The Paper reported Sunday. It will be overseen by Cao Bin, an expert in respiratory infections at Beijing’s China-Japan Friendship Hospital.
The news comes just three days after a paper was published in the New England Journal of Medicine claiming that remdesivir, which is not yet approved by drug regulators in any country, may have helped alleviate the symptoms of a 35-year-old male novel coronavirus patient in Washington state.
A GIF shows the coronavirus patient’s posteroanterior chest radiographs on the 4th, 7th , 9th, and 10th days of illness. From NEJM医学前沿 on WeChat
According to the NEJM paper, doctors on Jan. 26 administered remdesivir to the unidentified man, who had been diagnosed shortly after returning from a visit to Wuhan. The next day, his condition began to improve, and almost all of his symptoms had subsided by time of publication. The authors noted that they had observed no “adverse events” related to the treatment.
On Jan. 31, the day the paper was published, the drug’s developer, California-based Gilead Sciences, announced it had provided doses of the drug to China for use “in a small number of patients” and was working with China’s health authorities to set up a randomized, controlled trial to test the drug’s effectiveness against the novel coronavirus.
Historically, unapproved or in-development drugs have sometimes been used to treat diseases for which there are no accepted alternatives. Although there is no clinical data on remdesivir’s effectiveness against the novel coronavirus, the company claims it has been used in animal subjects to treat two other coronaviruses — SARS and MERS — with some success. A 2018 clinical trial found it was less effective than other drugs at treating Ebola, another viral disease.
On Feb. 2, China’s Center for Drug Evaluation announced it had approved Gilead Sciences’ application, with trials to begin the next day. As of time of publication, neither the China-Japan Friendship Hospital nor Cao, the doctor overseeing the trials, had responded to Sixth Tone’s requests for comment.
There are currently no drugs approved to treat the novel coronavirus. Although a number of companies including Johnson & Johnson and GlaxoSmithKline have announced work on a vaccine, development is expected to take years.
In the meantime, Chinese researchers are experimenting with existing antiviral drugs, including those for MERS and HIV, in hopes of finding an effective stopgap. In addition to the just-announced remdesivir trial, doctors at Wuhan’s Jin Yin-tan Hospital last month launched a randomized, controlled trial of the anti-HIV drugs lopinavir and ritonavir, a cocktail often marketed as Kaletra. The pairing, which a previous study suggested might be effective against SARS, work by targeting protease, an enzyme both HIV and coronaviruses use to reproduce.
Others are working to decode the novel coronavirus to speed up the search for potentially effective treatments. XtalPi, a Massachusetts-based biotech startup, announced Sunday that it had screened 2,900 FDA-approved drugs against novel coronavirus proteins and found 96 on-the-market drugs that could potentially inhibit the virus’ activity.
“We got a list of drug repurposing candidates and predicted their binding affinity ranking,” Lai Lipeng, the company’s co-founder and head of AI research, told Sixth Tone. “By sharing this list with the rest of the research community, we hope to help expand the search for a cure for the novel coronavirus, find partners who can experimentally validate these candidates, and hopefully shorten the time needed for an effective treatment to reach patients.”
Medical staff in full protective gear take care of a patient at Zhongnan Hospital in Wuhan, Hubei province, Jan. 23, 2020. Zheng Chaoyuan and Wei Jiaming for Sixth Tone
According to Lu Hongzhou, a leading virologist at Shanghai’s Huashan Hospital, new antivirals like remdesivir may be more effective than existing drugs such as lopinavir. Unlike lopinavir, which seeks to block the virus from reproducing, Lu says remdesivir acts directly on the virus itself.
“The drug would work on patients in any condition, and starting the treatment in the early stages of the illness can improve the prognosis,” Lu told Sixth Tone. “If we can get the virus early, we can stop it from further damaging the body and prevent the sick from getting sicker.”
Not everyone is as sanguine about the experimental drug’s potential, however. Jiang Xuefeng, a professor of chemistry and molecular engineering at East China Normal University in Shanghai, warns that one isolated case in the U.S. is not statistically significant. “No random, controlled, or blank samples were used in that case,” he told Sixth Tone. “The effectiveness of remdesivir cannot be determined by this single case.”
According to Jiang, even if remdesivir does prove effective in treating novel coronavirus patients, that doesn’t make it safe to use: It can take years, he said, to fully understand the pharmacological and toxicological side effects of new drugs.
“Take thalidomide, for example. It was sold to pregnant women as a cure for morning sickness in the 1950s, but four or five years later people discovered that it was causing birth defects,” Jiang said. “Given the circumstances, it’s totally understandable that people want a cure for the novel coronavirus as soon as possible. But as scientists, we have to be extremely cautious.”
Editors: Kilian O’Donnell and David Paulk.
(Header image: Moment/VCG)