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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04308317
Recruitment Status : Unknown
Verified March 2020 by Henan Provincial People's Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : March 16, 2020
Last Update Posted : March 16, 2020
Sponsor:
Information provided by (Responsible Party):
Henan Provincial People's Hospital

Study Description
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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
Corona Virus Disease 2019,COVID-19 Drug: Tetrandrine 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : March 5, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: tetrandrine tablets
No Intervention: Control Cohort
Treatment according to standard protocols without intervention


Outcome Measures
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Primary Outcome Measures :
  1. Survival rate [ Time Frame: 12 weeks ]
    Death event


Secondary Outcome Measures :
  1. body temperature [ Time Frame: 2 weeks ]
    inflammatory indicator


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04308317


Locations
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China, Zhejiang
Tetrandrine Tablets
Jinhua, Zhejiang, China, 321000
Sponsors and Collaborators
Henan Provincial People's Hospital
More Information
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Responsible Party: Henan Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT04308317    
Other Study ID Numbers: TT-NPC
First Posted: March 16, 2020    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
COVID-19
Tetrandrine
Additional relevant MeSH terms:
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COVID-19
Virus Diseases
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Tetrandrine
Antimalarials
 Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antiviral Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors