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

Sponsor
Henan Provincial People's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04308317
Collaborator
(none)
60
1
2
13.9
4.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Study of Tetrandrine Tablets Adjuvant Treatment With COVID-19
Anticipated Study Start Date :
Mar 5, 2020
Anticipated Primary Completion Date :
Mar 1, 2021
Anticipated Study Completion Date :
May 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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)

Drug: Tetrandrine
Tetrandrine 60mg QD for 1week
Other Names:
  • tetrandrine tablets
  • No Intervention: Control Cohort

    Treatment according to standard protocols without intervention

    Outcome Measures

    Primary Outcome Measures

    1. Survival rate [12 weeks]

      Death event

    Secondary Outcome Measures

    1. body temperature [2 weeks]

      inflammatory indicator

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tetrandrine Tablets Jinhua Zhejiang China 321000

    Sponsors and Collaborators

    • Henan Provincial People's Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Henan Provincial People's Hospital
    ClinicalTrials.gov Identifier:
    NCT04308317
    Other Study ID Numbers:
    • TT-NPC
    First Posted:
    Mar 16, 2020
    Last Update Posted:
    Mar 16, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Henan Provincial People's Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 16, 2020