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

Clinical Study of Tetrandrine Tablets Adjuvant Treatment With COVID-19

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 Overview

• Status: Unknown
• Conditions: Corona Virus Disease 2019,COVID-19
• Intervention / Treatment: Drug: Tetrandrine

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Jinhua, Zhejiang, China, 321000
      • Tetrandrine Tablets

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate	Death event	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body temperature	inflammatory indicator	2 weeks

Collaborators and Investigators

• Sponsor: Henan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 5, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 13, 2020
• First Posted (Actual): March 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 16, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; Tetrandrine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Virus Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Phytogenic; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Antiprotozoal Agents; Antiparasitic Agents; Calcium Channel Blockers; Antimalarials; Tetrandrine
• Other Study ID Numbers: TT-NPC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No