1. Learn about the combined diseases and medication of the subjects in detail, especially the drugs related to the prevention and treatment of novel coronavirus pneumonia that the subjects may use, remind the subjects to keep the relevant diagnosis, treatment and medication records, and bring them back to the Research Center for archiving when conditions permit or after the epidemic ends.

2. The investigator shall judge whether the suspected case of novel coronavirus infection is SAE. Generally speaking, for suspected cases of novel coronavirus pneumonia, home isolation is not considered as a serious adverse event (SAE), but subjects requiring isolation and observation in the hospital should be considered as SAE reports. Considering the different sufficiency of medical resources in different regions, the subjects received different medical measures. For example, in some regions, the suspected infected persons with mild symptoms are required to be hospitalized and isolated for observation in the hospital, which needs to be reported according to SAE, but the suspected infected persons with relatively serious symptoms in some regions are recommended to take measures of home isolation, which can not be reported as SAE.

3. In case of any SAE, remind the subject to treat nearby in time.When necessary, the research doctor and the receiving doctor shall communicate the subjects' participation in the clinical trial and assist the visiting doctor in treatment.

 Analyze the third point: 

（新型冠状病毒肺炎防控方案（第八版）的通知）

 · Population classification: Confirmed cases, suspected cases, close contacts of asymptomatic infected persons and their close contacts.

 · Diagnostic criteria: Divided into suspected cases and confirmed cases.

 · Treatment: If the clinical trial subjects belong to close contacts, close contacts of close contacts and general contacts, centralized isolation shall be adopted as required, and such personnel are asymptomatic. No medical intervention, only observation, no impact on the subject's safety risk, SAE will not be reported temporarily, and whether to report will be determined according to the outcome.

(Notice on the diagnosis and treatment plan for novel coronavirus pneumonia (trial version 9))

 · Population classification: Continued (Eighth Edition)

 · Diagnostic criteria: Divided into suspected cases and confirmed cases

 · Treatment ①: If the clinical trial subjects are suspected cases, they shall be treated in isolation in designated medical institutions or in single room as required. Such events shall be reported and followed up according to SAE. If they are classified as "confirmed cases" or "de isolation", they shall be reported to SAE follow-up report again. [Note: SAE is still recorded if it is not quarantined in the hospital (which may have an impact on public health safety)]

 · Treatment ②: If the clinical trial subjects are confirmed cases (symptomatic and asymptomatic infections), they shall be treated in isolation in designated medical institutions as required, and multiple people can be treated in the same ward for isolation treatment. For such events, if the isolation is lifted, follow-up shall be carried out; In case of diagnosis, according to the definition of SAE and subject safety risk assessment, it is necessary to report and follow up according to SAE.

1.Resulting in the need for hospitalization / extended length of stay

      if the diagnosis is confirmed and the patient is hospitalized, the need for hospitalization / extended length of stay will be met; If the diagnosis is confirmed and the patient is not hospitalized, the investigator considers it necessary to be hospitalized, which still meets the requirements of, resulting in the need for hospitalization / extension of hospitalization time (entering the shelter hospital is also hospitalized)

2.Death

3.Life threatening

      If the clinical trial subjects are confirmed cases and the severity of the disease continues to develop in the direction of adverse outcomes, such as respiratory failure, shock and multiple organ failure which needs ICU treatment, it  is consistent with life-threatening.

      Take the medical diagnosis name of the hospital as the name of SAE report. (for example: before diagnosis, it is named as "lung infection", "viral pneumonia" instead of "fever", "cough", etc. after the etiological test results are clear, update the SAE name.

 · Start time: Recorded / traceable onset time

 · End time: For non confirmed cases, the end is the release of isolation; For confirmed cases, the broad sense of de isolation should be that after the completion of centralized treatment isolation + home health monitoring, and the last nucleic acid test result is negative.

      According to the Ninth Edition (Trial) clinical classification, from mild to severe, it is divided into mild, moderate, severe and dangerous. In addition, the relevant provisions of the study protocol shall be followed.

The above is our sharing in this issue

We hope you can get something

What will be the next issue?

Let's look forward to it~