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A real world study comparing the efficacy and safety of Jingyin granule and paxlovid in the treatment of novel coronavirus pneumonia (covid-19) with high risk factors

Registration number：

ITMCTR2200005943

Date of Last Refreshed on：

2022-04-28

Date of Registration：

2022-04-28

Registration Status：

Prospective registration

Public title：

A real world study comparing the efficacy and safety of Jingyin granule and paxlovid in the treatment of novel coronavirus pneumonia (covid-19) with high risk factors

English Acronym：

Scientific title：

A real world study comparing the efficacy and safety of Jingyin granule and paxlovid in the treatment of novel coronavirus pneumonia (covid-19) with high risk factors

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2200059391 ; ChiMCTR2200005943

Applicant：

yuanweian

Study leader：

gaoyueqiu

Applicant telephone：

021-20256051

Study leader's telephone：

021-20256052

Applicant Fax：

Study leader's fax：

Applicant E-mail：

weian_1980@163.com

Study leader's E-mail：

gaoyueqiu@hotmail.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

528 zhangheng Road, Shanghai

Study leader's address：

528 zhangheng Road, Shanghai

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2022-1110-47-01

Approved file of Ethical Committee：

View

Name of the ethic committee：

IRB of Shuguang Hospital affiliated with Shanghai University of TCM 联

Date of approved by ethic committee：

2022/4/28 0:00:00

Contact Name of the ethic committee：

Geng Xi

Contact Address of the ethic committee：

528 zhangheng Road, Shanghai

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine

Primary sponsor's address：

Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine

Secondary sponsor：

Country：

CHINA

Province：

shanghai

City：

Institution
hospital：

Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine

Address：

528 zhangheng Road, Shanghai

Source(s) of funding：

Shanghai Municipal Health Commission

Target disease：

COVID-19

Target disease code：

Study type：

Interventional study

Study design：

Non randomized control

Study phase：

Others

Objectives of Study：

To evaluate the efficacy and safety of Jingyin granule in the treatment of COVID-19.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

Only those who meet all the following criteria can be selected: (1) Age ≥ 18 years old (including 18 years old), regardless of gender; (2) Meet the diagnostic criteria of COVID-19; (3) All subjects were required to meet one or more of the following high-risk factors for progression to severe covid-19, including death a. Age ≥ 60 years old; b. Cardiovascular disease (including congenital heart disease) or hypertension; c. Chronic lung diseases (e.g., chronic obstructive pulmonary disease [COPD], asthma [moderate to severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension); d. Diabetes; e. There are immunosuppressive diseases or receiving immunosuppressive treatment (such as the decline of immune function caused by long-term use of corticosteroids or other immunosuppressive drugs); f. Obese or overweight (BMI > 25 kg / m2); g. Active cancer; h. Chronic kidney disease; i. Current smokers; j. Neurodevelopmental diseases (e.g. cerebral palsy, Down syndrome) or other diseases that lead to medical complexity (e.g. genetic or metabolic syndrome and severe congenital abnormalities); k. Need relevant medical support (not related to covid-19) (such as organotomy, gastrostomy or positive pressure ventilation); l. Other medical conditions or factors judged by researchers may also put individual patients at high risk of developing severe covid-19. The benefits and risks of individual patients should be weighed. (4) Voluntarily participate in the experiment and sign the written informed consent.

Exclusion criteria：

If any of the following criteria is met, it shall be excluded: (1) According to the judgment of the researcher, the subject may progress to severe / critical illness covid-19 before randomization; (2) SpO2 ≤ 93% or PaO2 / FiO2 ≤ 300 in indoor air at sea level, or respiratory rate ≥ 30 / min; (3) Mechanical ventilation is needed or expected to be urgently needed; (4) The subject has eye diseases (such as inflammation, vascular malformation, retinal hemorrhage or detachment, optic neuropathy or fundus disease); (5) During the screening period, there are one of the following situations: a) ALT or ast > 1.5x ULN b)eGFR <30 mL/min (6) Known allergy to any ingredient used in the intervention drug dosage form; (7) Any medical treatment that the investigator believes will impair the subject's safety; (8) The subject has received sars-cov-2 monoclonal antibody treatment or preventive or antiviral treatment; (9) The subject has received convalescent covid-19 plasma treatment; (10) The subjects used the drugs prohibited in the combination Manual of matavir tablets / ritonavir tablets; (11) Subjects have participated in clinical studies involving study drug intervention in the past 30 days. If previous studies; (12) If the half-life of drug intervention is long, it should go through 5 half-life or 30 days (whichever is longer); (13) Any other type of medical research that the subjects are considered to be incompatible with the research in science or medicine at the same time; (14) Female subjects were pregnant or breastfeeding or planned pregnancy during the study period; (15) The wife or partner of male subjects planned to become pregnant during the study period.

Study execute time：

From 2022-05-01

To      2022-12-31

Recruiting time：

From 2022-05-01

To      2022-06-30

Interventions：

100

Group：

Test group

Sample size：

Intervention：

Basic treatment + Jingyin granules, 2 bags / time, tid × 7 days;

Intervention code：

100

Group：

control group

Sample size：

Intervention：

Basic treatment + paxlovid (nematevir 300mg + ritonavir 100mg), Q12h, 5 days

Intervention code：

Total sample size ： 200

Countries of recruitment
and research settings：

Country：

China

Province：

Shanghai

City：

Institution/hospital：

Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine

Level of the institution：

Tetiery A

Outcomes：

Outcome：

Nucleic acid negative conversion rate within 7 days

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Clinical symptom efficacy: refers to the disappearance rate and improvement rate of clinical symptoms before and after treatment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Average length of stay: the average time from admission to discharge

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Conversion rate to severe within 28 days

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Average time of nucleic acid turning negative: the time from the patient's first positive report of CDC novel coronavirus nucleic acid test in Shanghai to two turns negative at an interval of more than 24 hours

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Not yet recruiting

18
Min age years
不限
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Not random

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

De identify the database.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Electronic Data Capture, EDC

Data Managemen Committee：

Not yet

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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