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Tetrandrine Tablets Used in the Treatment of COVID-19 (TT-NPC)

Primary Purpose

Corona Virus Disease 2019,COVID-19

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Tetrandrine
Sponsored by
Henan Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corona Virus Disease 2019,COVID-19 focused on measuring COVID-19, Tetrandrine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tetrandrine Tablets

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tetrandrine Cohort

Control Cohort

Arm Description

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)

Treatment according to standard protocols without intervention

Outcomes

Primary Outcome Measures

Survival rate
Death event

Secondary Outcome Measures

body temperature
inflammatory indicator

Full Information

First Posted
March 4, 2020
Last Updated
March 13, 2020
Sponsor
Henan Provincial People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04308317
Brief Title
Tetrandrine Tablets Used in the Treatment of COVID-19
Acronym
TT-NPC
Official Title
Clinical Study of Tetrandrine Tablets Adjuvant Treatment With COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 5, 2020 (Anticipated)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
May 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henan Provincial People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corona Virus Disease 2019,COVID-19
Keywords
COVID-19, Tetrandrine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tetrandrine Cohort
Arm Type
Experimental
Arm Description
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)
Arm Title
Control Cohort
Arm Type
No Intervention
Arm Description
Treatment according to standard protocols without intervention
Intervention Type
Drug
Intervention Name(s)
Tetrandrine
Other Intervention Name(s)
tetrandrine tablets
Intervention Description
Tetrandrine 60mg QD for 1week
Primary Outcome Measure Information:
Title
Survival rate
Description
Death event
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
body temperature
Description
inflammatory indicator
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Tetrandrine Tablets
City
Jinhua
State/Province
Zhejiang
ZIP/Postal Code
321000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tetrandrine Tablets Used in the Treatment of COVID-19

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