Clinical trials approved for anti-viral medicine

With the public eagerly anticipating effective drugs to cure the novel coronavirus pneumonia, a medical ethics committee at the forefront of fighting the outbreak in Wuhan has quickened the pace of approving clinical trials.

Several programs related to the diagnosis and treatment of the disease have gained ethical approval from Huazhong University of Science and Technology and are being carried out by the university, including two drugs that are under clinical trials, said Chen Jianguo, vice-president of the university.

The two drugs are remdesivir, a drug being developed by US-based pharmaceutical company Gilead, and chloroquine phosphate, which is available on the market to treat malaria.

In addition to the university, other institutes in China are conducting clinical trials of the two drugs to test whether they are effective and safe for novel coronavirus infected patients. Currently, there is no single effective medicine available to treat the disease.

To allow remdesivir to enter clinical trials as soon as possible, members of the Ethical Committee on Drug Clinical Trials under the university completed inspection online in early February, said Chen Hui, director of the committee.

"Due to tight schedules and difficulties caused by the lockdown of Wuhan and the university, we adopted an online inspection method for remdesivir," she said. "Members inspected documents regarding the clinical trial of the drug online, and most of them proposed suggestions for the trial."

The committee approved the plan for the drug's clinical trial－which involves more than 700 novel coronavirus infected patients in both mild and serious conditions－considering both the anticipated effect of the drug and its potential risks.

It also gave suggestions such as providing preclinical trial safety evaluation and closely following the safety of patients under trial.

Later, the committee approved a survey to be conducted by university researchers on medical care provided to virus patients, she said.

Despite the accelerated approval, the committee strictly followed both national and international laws and regulations while giving inspection and approval to ensure that the projects conform to ethical standards and that the rights of patients under trial are protected, she said.

Chen Jianguo, vice-president of the university, said that in addition to pharmacists, representatives from other sectors including doctors and lawyers have also participated in ethical review and approval of medical projects carried out by the university or its affiliated hospitals to protect the rights of those under trial, including their privacy.

Chen Hui, the ethical committee's director, said after giving approval to start clinical trials, members of the committee are also following these projects to ensure conformity to ethical standards while they are being carried out.