Behind the launch of the new domestic crown drug VV116: how to carry out clinical studies under the epidemic

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On January 29th, after the emergency review and approval by the State Drug Administration, Shanghai’s independently developed Class 1 innovative drug, the oral small molecule new coronavirus infection treatment drug Mindevi (VV116), was conditionally approved for marketing. Last year during the Great Shanghai Defense, led by the President of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, academician Ning Guang and Professor Zhao Ren, together with seven designated hospitals for neo-coronavirus treatment, including Shanghai Pudong Hospital, the city’s public health center, Renji Hospital, Shuguang Hospital, Tong Ren Hospital and Huashan Hospital, jointly completed the VV116 and Parovid “head-to-head “The results were published in the New England Journal of Medicine (NEJM), one of the leading journals in the medical field, on December 29, 2022. The clinical research team at Ruijin Hospital recalls the journey of the intense phase III clinical study during last year’s outbreak with great emotion.

The floor is the desk, “North Hospital beggar gang” experience unforgettable

At the end of March 2022, when the entire clinical research team arrived at the Ruijin Hospital Jiading North Campus site, the site had just opened. Because the Jiading North Campus was temporarily notified of the transformation into a designated hospital, the entire transformation took only 24 hours, and the office conditions were far inferior to those of normal days.

Vice President Zhao Ren had to “squeeze” a classroom from the third floor of the Proton Hospital office building for the team to work, which was not easy at that time when the “land” was very tight. The whole classroom was about 60 square meters, and there were more than 20 research team members at that time. The working conditions were very difficult, “there were not enough tables, the floor came to make up”, documents, cases, forms, etc. were laid on the floor, everyone squatted on the floor to work, and some people found scrap cardboard boxes as chairs.

During that time, everyone lived and ate together, and the work had to be completed on the same day, so the average daily work of 17 hours, even meals also have to “squeeze” out time, three mouthfuls of two mouthfuls into the mouth. At that time left a few photos of young doctors squatting in the corridor to eat, usually handsome and dashing doctor boys are a bit of a mess, long hair, broken clothes, squatting on the floor, holding a lunch box wolf swallowed, we all laughingly called themselves “North Hospital beggars”.

The “signer” under the night, leaving a warm picture

In order to ensure the safety of the transfer of patients into the group, medical director Gao Weiyi has to connect all the links, from the patient’s medical history, laboratory tests, nucleic acid testing to the nucleic acid report, the initial selection of patients who meet the conditions of the group, immediately arranged for the transfer of special teams to transfer, from the departure of the fever clinic, the car to the arrival of the designated hospital or cabin, the whole process of tracking, until the other side to confirm the receipt of the patient, can really put down The whole process is followed until the patient is confirmed to be received by the other party.

Every time the patient needs to be transferred, the patient is in a hurry, but the ambulance time is uncertain, so Gao Weiyi calls 120 under the night while contacting the designated hospital, and at the same time, he remotely communicates with the nurses of the fever clinic by making hand signals. At 1:00 a.m., Gao Weiyi and Zhuang Lei waited anxiously under the night with sign language 200 meters apart, which was the most heartwarming picture to ensure the safety of patients.

Being able to eat ice cream is happier than New Year’s Eve

The clinical research team at Ruijin Hospital is mostly young, and we all call each other “kids”. From March last year when they moved into the research ward building until May, no one had ever returned home. No one expected that May 2022 would be so hot, with the temperature reaching 30 degrees Celsius on some days.
Whenever President Ning Guang visited the North Campus for meetings and progress checks, he would ask everyone, “Are you short of anything?”

When asked more often, the sweating “children” went from being afraid to say anything to exclaiming, “It would be nice if we had ice cream!”

Everyone took it as a joke, but in their hearts they understood that at this juncture, how could there be ice cream? I didn’t expect that in a few days the ice cream would arrive and the electric fan would arrive. A few days later, we actually got KFC. Everyone was so excited and happier than New Year’s Eve.
Patients’ trusting words are the “source of motivation” for doing research

In order to screen more patients who met the enrollment criteria, the clinical research team of Ruijin Hospital not only intensified the search for suitable patients in the fever clinic of the main hospital, but also took the initiative to contact the community and select patients who met the enrollment criteria through adequate telephone communication.

At that time, because of the limited acceptance capacity of the designated hospital or the Fangzhan, there were many confirmed patients in the community to be transferred. The master of the transfer team of Ruijin Hospital, together with the community cadres, went door to door to find the patients according to their registered addresses and, after fully informing them of their consent, transferred them to the designated hospital or the Fangzhan, sometimes all the family members were Yang, sometimes some of them were confirmed.

Each time, the patients would express their gratitude and say “I am willing, we are all willing to participate”. Every time I thought of their expectant eyes, Gao Weiyi felt a great responsibility, “This is the biggest source of motivation for us to do clinical research, right?

Doing clinical research while comforting patients and families

“Hello, Dr. Cao, is my mother doing better in the past two days? Her cell phone is off, she didn’t bring the charger when she was transferred, I can’t reach her ……”

At 7:50 a.m., the first phone call from the “public machine” rang. “Don’t worry! Your mother’s fever has gone down in the past two days, and she still has some mild coughing from yesterday’s bedside assessment, and she is much more energetic than when she arrived. I’ll talk to the nurse in the cabin and ask her to come to your mother’s bedside and put her on speakerphone with her work phone so you can talk, okay?”

“Dr. Cao, that’s very kind of you!” Such phone calls rang out every day in the clinical research ward.

During that time, people used to call their work cell phones “public phones”, which played an important role in connecting the inside and outside of the cabin, patients and their families.

Dr. Cao Zhujun of the Infectious Diseases Department said, “The subjects enrolled in the study were generally older, and many elderly people were transferred to the study when they were positive, and their families stayed at home because they were negative and cut off from the elderly. While our project team conducts the study, it also acts as a bridge to pass on information about the elderly’s hospitalization to their families.”

The group meets every night, a “magpie bridge meeting on the cloud” for the couple

“How is Renji Hospital today, how many cases have been admitted?” Academician Ning Guang supervises the progress of each sub-center in the nightly project advancement meeting. Gaoyuan, director of the Intensive Care Unit at Renji, reported, “Many patients over here are eager to participate, and now I lead group visits during the day, and only start talking about informed, screened subjects at night, so let’s do it first.” “Great! Patients are willing to participate is good news, and Gao is with me!” It turns out that Gao Weiyi, the wife of Director Gaoyuan, is the Director of the Medical Department at Ruijin Hospital.
During the epidemic, they were stationed at their respective hospitals and did not see each other for months. But fortunately, the daily meeting to promote the subject is also a “magpie bridge on the cloud”, which has become a rare platform for the couple to “meet”.

In the Ruijin Hospital Infection Department Dr. Cao Zhujun impression, every night when the project advancement meeting, Pudong Hospital’s director Bao Hong just came out of the square cabin. Director Bao led the group to check in during the day, and only at night had time to talk about informed, screened subjects, because many patients wanted to participate, making Bao Hong “busy and happy”. Gaoyuan of Renji Hospital also often rushed to open the computer to participate in the meeting just after rescuing patients. In those three months, the research experts of major hospitals who participated in the clinical study were working day and night, treating patients during the day and studying seriously late at night, and this all came from the responsibility of seeking knowledge and exploring in order to overcome the disease and benefit patients.