Shandong a hospital 4,000 yuan to recruit new crown patients to try drugs: legal and safe, multiple hospitals are recruiting

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Recently, a notice of “recruiting patients with novel coronavirus pneumonia” has sparked attention online.

According to the WeChat public number of the First Hospital of Zibo City, Shandong Province, on the evening of January 1, the hospital issued a notice “Recruiting patients with novel coronavirus pneumonia,” saying that the Department of Respiratory and Critical Care Medicine is conducting “a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of GS221 in the treatment of patients with mild or common novel coronavirus pneumonia. “This study is enrolling patients with mild or common novel coronavirus pneumonia and is intended to be conducted at approximately 20 clinical research centers nationwide, with a total of 312 patients expected to be enrolled in Part B.

After screening, eligible subjects will be randomized in a 3:1 ratio to receive either 5 days of GS221 or placebo. Each subject will receive the study drug (GS221 or placebo) with warm water, not chewable. Oral doses of 375 mg once daily were administered on the first day, and maintenance doses of 125 mg once daily were administered orally on the following 4 days for a total of 5 days, with follow-up until confirmation of nucleic acid conversion and full resolution of clinical symptoms or study day 14.

Zibo First Hospital indicated that patients should be contacted if they initially meet the following criteria: 18 ≤ age ≤ 70 years; diagnosis of New Coronary Pneumonia in mild and common patients; positive by nucleic acid testing or antigen testing; cough, shortness of breath or dyspnea, fever, chills, fatigue, body aches or muscle pain, diarrhea, nausea, vomiting, headache, sore throat, nasal congestion, runny nose, loss of taste or sense of smell Any symptoms associated with new coronary pneumonia; negative pregnancy test before enrollment for women of childbearing age; no other clinical trials within one month.

On January 4, it was reported that the staff of Zibo First Hospital said, “At present, insurance, and trial grants are provided to each patient participating in the clinical study. So far, there are no obvious side effects, and in the best case, there are patients who are able to turn negative in 5 days.”

The hospital is currently conducting the second batch of the trial, which has previously been conducted as a 1:1 trial (i.e., those enrolled were tested blindly in a 1:1 ratio, with one patient taking the drug and one patient taking a placebo), and the patients who participated in the clinical trial were not affected by significant drug side effects. So the second batch of the trial, which will be conducted using a 3:1 ratio, will require 312 participants, according to the news.

The staff said that after the current batch of trials, another trial will be needed before the drug will be marketed.

On January 5, the reporter called the phone number of the contact person reserved on the notice, Ms. Xu. When the reporter asked if it was the first hospital in Zibo, she confirmed it and said that recruitment is still underway and that you need to confirm a positive result with the antigen first, bring your ID card and bank card and go to the hospital on an empty stomach to have your blood drawn. Patients do not need to be hospitalized in the hospital, only need to come to the hospital 10 trips, when the time will get 4,000 yuan. “In the middle some times do not need nucleic acid, only need to use their own card test paper (test), signature writing diary shot out, as long as it is positive, can not come, we are also accepted.”

Ms. Xu also said that the recruitment of new crown patients taking the drug is not listed, but “quite safe.” “Part of the experiment has been done in the early stage. We did a highly allergic subject who was allergic to almost every drug and usually could only take Chinese medicine. He took the medicine and was observed for two hours with no problems. It is now the fourth day and he has not had any problems either. I can’t guarantee that this medicine is absolutely harmless, it’s impossible that all medicines don’t have a little side effect, but people with high allergies are not having problems, we shouldn’t have any problems either.”

On January 5, the reporter contacted the first hospital in Zibo City, a staff member said that the hospital is informed, “otherwise it will not be issued on the public number.”

Another staff member told reporters that he heard that recruitment activities seem to have ended at the weekend. “This time it was a company that was recruiting, and we were helping them promote it. The activity is certainly legal, also reported to the leadership, this company and many hospitals have cooperation, not only we are recruiting, many hospitals have this recruitment activities.”

The reporter noted that on January 2, Zibo Municipal Hospital also released a similar recruitment message, the hospital said: the Department of Respiratory and Critical Care Medicine of our hospital is conducting “a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of GS221 in the treatment of patients with mild or common novel coronavirus pneumonia”, the program No. GS221-2022-001.

On the morning of Jan. 5, reporters contacted Ms. Yan, the contact person at the bottom of the notice, who said she was still recruiting, but entering the clinical trial required patients to be within 72 hours of the onset of the disease. “We are required to take this drug for 5 days, the drug is has been successfully marketed in Japan. Each clinical trial will ensure the safety of the subjects, the risk is that patients may have some adverse reactions after taking the drug, which varies from person to person.”

On January 5, the reporter repeatedly called the phone number of the Zibo Health and Health Commission, as of press time, has been unanswered.

A staff member of the Zibo Municipal People’s Government responded to the reporter that he had not heard of the matter for the time being, and needed to reply to the health department after understanding the situation.

In addition, Qilu Pharmaceuticals also released a clinical trial recruitment advertisement for its new crown oral drug, the clinical trial site in Shandong University Qilu Hospital. Each subject will receive the drug for free and the study period will be one month. Subjects will not be required to pay for the study drug and related tests and treatments, and will receive a certain amount of compensation for the trial.

File photo

In addition, it was reported that on the evening of December 28, 2022, Yuanda Pharmaceuticals announced that GS221, an innovative oral small-molecule anti-neo-coronavirus infection 3CL protease inhibitor independently developed by the Group, was issued a notice of approval for new drug clinical trials by the State Drug Administration on September 20, 2022, and three corresponding clinical trial studies were promptly conducted. The results of the completed clinical trials have shown good safety and tolerability of the drug in subjects, and no serious or discontinuation-causing adverse events have been observed.

In addition to Yuanda Pharmaceuticals, several new crown treatment drug development pharmaceutical companies are also recruiting patients, including Centrum Pharmaceuticals, Junshi Biologicals, Kexing Pharmaceuticals, and Zongsheng Pharmaceuticals.

According to the news of December 28, 2022, in order to accelerate the progress of the new crown treatment drug marketed in Jiangsu Province, Jiang Wei, deputy director of Jiangsu Provincial Drug Administration, recently hosted a special scheduling meeting on the research progress of SIM0417, a new crown treatment drug jointly developed by Centron Pharmaceuticals, Shanghai Institute of Drug Research, Chinese Academy of Sciences and Wuhan Institute of Virus Research, an oral drug with 3CL target. On December 16, 2022, all 1,208 patients were enrolled in the phase III clinical trial of the project, which is the first in China for 3CL target drugs and is expected to be marketed in February 2023 at the earliest.

In addition, according to a notice issued by the Clinical Trial Center of Shenzhen Third People’s Hospital, Zongsheng Pharmaceutical, Wuhan Institute of Biological Products and Kexing Pharmaceutical are also recruiting positive patients in the near future. The three drugs are RAY1216 tablets, F61 injection and shen26 capsules.