Tetrandrine Tablets Used in the Treatment of COVID-19

NCT04308317 | Unknown Phase 4

• 1 other identifier: TT-NPC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Corona Virus Disease 2019,COVID-19

Keywords

COVID-19; Tetrandrine

Outcome Measures

Primary Outcomes (1)

• Survival rate

  Death event

  12 weeks

Secondary Outcomes (1)

• body temperature

  2 weeks

Study Arms (2)

Tetrandrine Cohort

EXPERIMENTAL

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

Control Cohort

NO INTERVENTION

Treatment according to standard protocols without intervention

Interventions

Tetrandrine DRUG

Tetrandrine 60mg QD for 1week

Also known as: tetrandrine tablets

Tetrandrine Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

Study Sites (1)

Tetrandrine Tablets

Jinhua, Zhejiang, 321000, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

tetrandrine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 16, 2020
• Study Start: March 5, 2020
• Primary Completion: March 1, 2021
• Study Completion: May 1, 2021
• Last Updated: March 16, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)