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• Chinese Clinical Trial Registry to COVID-19, Where is the Way Out to the Diagnosis and Treatment Therapy
  YaYun Wu, Xun Huang and HuaYe Jiang
  Published on: 6 September 2021

• Published on: 6 September 2021

  Chinese Clinical Trial Registry to COVID-19, Where is the Way Out to the Diagnosis and Treatment Therapy

  • YaYun Wu, Master of medicine Departments of Infection Control, Xiangya Hospital, Central South University, Changsha，HuNan 410008,China
  • Other Contributors:
    • Xun Huang, Professor,Infectious surgeon
    • HuaYe Jiang, Master of medicine

  Chinese Clinical Trial Registry to COVID-19, Where is the Way Out to the Diagnosis and Treatment Therapy
  YaYun Wu1, HuaYe Jiang1, Xun Huang1*
  1Departments of Infection Control, Xiangya Hospital, Central South University, Changsha，HuNan 410008,China
  *Corresponding author:Xun Huang，MD, Department of Infection Control, Xiangya Hospital, Central South University, Changsha ， HuNan 410008,China (Email: huangxun@mail.csu.edu.cn)
  To the Editor:
  During the epidemic period of Coronavirus Disease 2019 (COVID-19), many doctors and researchers conducted clinical trial on COVID-19 in China. Until 04:00 am 16 April , 2020, there were 598 clinical trials on COVID-19 registered in Chinese Clinical Trial Register (ChiCTR), including 309 (51.67%) interventional trials and 248 (41.47%) observational trials and 41 （6.86%） diagnostic trials. There were 43 studies have been withdrawn1.We analyze the data for the period, 6 clinical trials were registered in January (1.23-1.31), all of them were interventional studies.There were 291 clinical trials registered in February (2.1-2.29), including 193 (66.32%) interventional studies， 83 (28.52%) observational studies and 15 (5.16%) diagnostic studies.There were 254 clinical trials registered in March (3.1-3.31), including 93 (36.61%) interventional studies,138 (54.33%) observational studies and 23 (9.06%) diagnostic studies. There were 47 clinical trials registered in Apri...

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  Chinese Clinical Trial Registry to COVID-19, Where is the Way Out to the Diagnosis and Treatment Therapy
  YaYun Wu1, HuaYe Jiang1, Xun Huang1*
  1Departments of Infection Control, Xiangya Hospital, Central South University, Changsha，HuNan 410008,China
  *Corresponding author:Xun Huang，MD, Department of Infection Control, Xiangya Hospital, Central South University, Changsha ， HuNan 410008,China (Email: huangxun@mail.csu.edu.cn)
  To the Editor:
  During the epidemic period of Coronavirus Disease 2019 (COVID-19), many doctors and researchers conducted clinical trial on COVID-19 in China. Until 04:00 am 16 April , 2020, there were 598 clinical trials on COVID-19 registered in Chinese Clinical Trial Register (ChiCTR), including 309 (51.67%) interventional trials and 248 (41.47%) observational trials and 41 （6.86%） diagnostic trials. There were 43 studies have been withdrawn1.We analyze the data for the period, 6 clinical trials were registered in January (1.23-1.31), all of them were interventional studies.There were 291 clinical trials registered in February (2.1-2.29), including 193 (66.32%) interventional studies， 83 (28.52%) observational studies and 15 (5.16%) diagnostic studies.There were 254 clinical trials registered in March (3.1-3.31), including 93 (36.61%) interventional studies,138 (54.33%) observational studies and 23 (9.06%) diagnostic studies. There were 47 clinical trials registered in April (4.1-4.16), including 17 (36.17%) interventional studies, 27 (57.45%) observational studies and 3 (6.38%) diagnostic studies. The purpose of these interventional clinical trials is to explore the effects of different therapies on COVID-19, while the purpose of these observational clinical trials is to summarize the epidemiological characteristics,clinical symptoms and prognosis of COVID-19.
  From January to February, the number of people infected with the novel coronavirus (SARS-CoV-2) increased rapidly in China and the most important task is to treat the patients, so the researchers pay more attention to interventional clinical trials. COVID-19 was gradually controlled in China after March ,thus more efforts were made to summarize the epidemiological characteristics, clinical manifestations and prognosis of COVID-19 by china experts. Therefore, clinical trials in March and April focused on observational studies mostly.Changes in the types and quantities of clinical trials from January to April also reflect the trend of COVID-19 in China.
  There were 95 clinical trials about severe and critical cases, 8 clinical trials about deaths, 12 clinical trials about newborn and children, 5 clinical trials about the elderly among the 598 studies.Relevant literature showed that the newborn can be infected by pregnant women with COVID-192. And there were two clinical trials on mother-to-child transmission of COVID-19.
  The minimum duration of these clinical trials was 6 days and the maximum duration was 3 years. Most of them were short-term trials and many studies last 1 to 6 months because it is not easy to find patients with COVID-19 and collect specimens when COVID-19 is controlled.There was no gender requirement for participants.Patients specimens included respiratory tract specimens (sputum, throat swab), saliva, blood, feces, urine, tissue specimens.Among these clinical trials, the minimum number of subjects was 8, which reflected the insufficient sample size of some trials.Clinical trials are usually exclusive, and if a patient participates in one intervention trial, he or she cannot join in another study.With the control of COVID-19 in China, the number of people infected goes down. Therefore, some clinical trials may not be able to recruit enough patients and researchers can not draw reliable conclusions without sufficient sample size.
  COVID-19 was confirmed by fluorescent reverse transcription polymerase chain reaction (RT-PCR) detection of positive nucleic acid of SARS-CoV-2, however, this technique is time-consuming and laborious. If there are a large number of suspected patients, the detection speed may be slow when use PCR technique only.The lung CT scan of patients with COVID-19 showed lesions, therefore, artificial intelligence imaging system can also play a role in diagnosis. It can complete the screening of suspected cases in a short time, and assists the imaging diagnosis under high intensity work.And there were two studies about the application of artificial intelligence imaging system in the diagnosis of COVID-19.
  According to the Chinese COVID-19 Diagnosis and Treatment Protocol (7th edition) 3, symptomatic support therapy and antiviral therapy are the most important treatment .Among the clinical trials of antiviral drugs, there were 16 studies on chloroquine phosphate, 6 studies on interferon ,11 studies on lopinavir/ritonavir, 1 studies on ribavirin, 4 studies on azvudine and 4 studies on abidor.Among the clinical trials of treatment options in severe and critical cases, there were 4 studies on extracorporeal membrane oxygenation(ECMO) techniques, 11 studies on convalescent patients’ plasma therapy, 2 studies on blood purification therapy, 4 studies on glucocorticoid therapy, 6 studies on monoclonal antibody therapy, and 22 studies on stem cell therapy.People died from COVID-19 were severe and critical patients usually,so we want to find appropriate treatment through the studies of severe and critical cases and reduce the mortality.COVID-19 can not only injure the body of patients but also affect their psychological state. People often feel anxiety and fear during outbreaks of infectious disease, so the study of psychology is important too. There were 37 studies on psychologic status of health care workers and patients. With these psychological studies and guidance, fear and anxiety of patients may be reduced.There were 126 studies about Traditional Chinese Medicine and it also played an important role in the treatment of COVID-19.
  At present, the spread of COVID-19 are controlled basically in China, but the situation is getting worse in other countries.The imported transmission between different countries will make the epidemic difficult to control, so it is urgent to develop an effective and safe vaccine.There were 5 clinical trials on COVID-19 vaccine registered in ChiCTR. One of which has completed phase I clinical trial, conducted by Institute of biological engineering, academy of military sciences.108 subjects have been vaccinated, including three groups: low-dose group, medium-dose group and high-dose group (36 subjects each group).And the researchers started phase Ⅱ clinical trial already, this is the first COVID-19 vaccine project which has started phase Ⅱ clinical trial in the world.In addition to China, the process of vaccine research is also under way in other countries and it is hopeful to develop an effective vaccine in the near future.
  Although COVID-19 has been basically controlled in China, these clinical trials can provide experience for future recurrence and provide reference for the diagnosis and treatment in other countries.The concept of Community of Shared Future for Mankind (CSFM) tell us that only if COVID-19 is under control in all countries can we get out of current predicament. It is hopeful that the results of these clinical trials will play a role in the control of COVID-19 and bring us normal life as soon as possible.

  References
  1.Index of clinical trials on COVID-19（Updated to 04:00 AM Beijing time, 16 April , 2020)
  (http://www.chictr.org.cn/uploads/documents/2020/04/16/88f0c7bb71dc44efb5...)
  2.Chen H, Guo J, Wang C, et al. Clinical characteristics and intrauterine vertical transmission potential of COVID-19 infection in nine pregnant women: a retrospective review of medical records[J]. Lancet,2020,395(10226):809-815.
  3.Notice on the issuance about diagnosis and treatment protocol of COVID-19 (7th edition):General office of the national health commission [2020] No.184(http://www.gov.cn/zhengce/zhengceku/2020-03/04/content_5486705.htm)

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  Conflict of Interest:
  None declared.

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