Tetrandrine Tablets Used in the Treatment of COVID-19

NCT ID: NCT04308317

Last Updated: 2020-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-05
• Study Completion Date: 2021-05-01

Brief Summary

The study is expected to treat patients with mild and severe neo-coronary pneumonia through standard treatment regimens in combination with tetrandrine tablets, thereby reducing the clinical progress of some patients, improving prognosis, reducing the incidence of pulmonary fibrosis during rehabilitation, and improving patients' quality of life.

Detailed Description

Since December 2019, a number of cases of pneumonia infected with the new coronavirus have been found in wuhan, hubei province.Has now become a global epidemic of crisis.

After recent frontline anti-epidemic experience, the diagnostic and treatment specifications for new coronary pneumonia have been updated several times. In the latest country, "Specifications for the Diagnosis and Treatment of New Types of Coronary Pneumonia (Trial Version 6)", the traditional Chinese medicines have again emphasized For the treatment of patients, traditional Chinese medicine preparations such as Xuebijing and Qingfei Paidu Decoction have been recommended, but the introduction of anti-fibrosis related drugs is still lacking.Tetrandrine is a traditional Chinese medicine. Previous research has shown that it is an antagonist of calmodulin, has anti-tumor, anti-inflammatory effects, and can effectively inhibit fibroblasts, thereby inhibiting pulmonary fibrosis.The study is expected to treat patients with mild and severe neo-coronary pneumonia through standard treatment regimens in combination with tetrandrine tablets, thereby reducing the clinical progress of some patients, improving prognosis, reducing the incidence of pulmonary fibrosis during rehabilitation, and improving patients' quality of life.

Conditions

Corona Virus Disease 2019,COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tetrandrine Cohort

After the subjects were enrolled, they were given "Tetrandrine 60mg QD" for a course of 1 week(Take 6 days, stop using for 1 day)

Group Type: EXPERIMENTAL

Tetrandrine

Intervention Type: DRUG

Tetrandrine 60mg QD for 1week

Control Cohort

Treatment according to standard protocols without intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tetrandrine

Tetrandrine 60mg QD for 1week

Intervention Type: DRUG

Other Intervention Names

tetrandrine tablets

Eligibility Criteria

Inclusion Criteria

• Patients with mild and severe cases who have been diagnosed with new coronavirus pneumonia according to the "Pneumonitis Diagnosis and Treatment -
• Plan for New Coronavirus Infection"
• Age 18 to 75 years;
• Sign the informed consent voluntarily.

Exclusion Criteria

• With active tuberculosis, idiopathic pulmonary fibrosis, bronchial asthma, bronchiectasis, pulmonary embolism, patients with chronic respiratory failure or other severe respiratory disease;
• According to the "pneumonia diagnosis and treatment program for new coronavirus infection" (trial version 6), critically ill patients
• With severe patients with disease of heart head blood-vessel, malignant arrhythmia, unstable angina, acute myocardial infarction and death, cardiac function level 3 and above, stroke, cerebral hemorrhage, etc.);
• With severe liver and kidney diseases (severe liver disease refers to cirrhosis, portal hypertension and varices bleeding, severe kidney disease including dialysis, kidney transplantation);
• Pregnant and lactating women;
• Severe cognitive and mental disorders;
• Clinical investigators who were participating in other interventions within 1 month prior to inclusion

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tetrandrine Tablets

Jinhua, Zhejiang, China

Countries

China

Other Identifiers

TT-NPC

Identifier Type: -

Identifier Source: org_study_id