Tetrandrine Tablets Used in Hospitalized Adults With COVID-19

November 16, 2023 updated by: Sun Yongchang, Peking University Third Hospital

Tetrandrine Tablets Used in Hospitalized Adults With COVID-19: a Double-blind, Placebo-controlled, Randomised Trial

The primary objective of this study is to evaluate the effectiveness of tetrandrine tablets in preventing the progression of COVID-19 from severe to critical.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to evaluate the effectiveness of tetrandrine tablets in preventing the progression of COVID-19 from severe to critical. The secondary objective is to evaluate the clinical indicators of COVID-19 with tetrandrine tablets treatment.

Study Type

Interventional

Enrollment (Estimated)

414

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yongchang Sun, M.D.
  • Phone Number: 86-15611963697
  • Email: suny@bjmu.edu

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Sign informed consent form voluntarily for the trial.
  2. Male or female aged between 18 and 85 years (inclusive).
  3. Clinically or laboratory confirmed COVID-19 within the past 7 days, as determined by a positive RT-PCR test or a positive antigen test.
  4. Under resting conditions, oxygen saturation ≤93% when breathing air, or P/F value ≤ 300 mmHg (1 mmHg = 0.133 kPa).
  5. No birth plan and must agree to take effective contraceptive methods.

Exclusion Criteria:

  1. Received a vaccine within 4 weeks prior to the study, or plan to receive a vaccine during the study period, or received treatment with tetrandrine tables prior to enrolling in the study.
  2. Patient must be on invasive mechanical ventilation/ECMO at baseline.
  3. Any clinically important serious diseases unstable or uncontrolled.
  4. Allergy history to any biological or other agent.
  5. Patient has severe mental or psychological abnormalities, cognitive impairment or intellectual disability before being diagnosed with COVID-19.
  6. Subjects who are pregnant or breastfeeding, or plan to become pregnant during the study.
  7. Investigator think the subject should not participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tetrandrine group
Tetrandrine 60mg TID for 28 days
Drug: Tetrandrine
tetrandrine TID for 28 days
Placebo Comparator: placebo group
placebo TID for 28 days
Drug: Tetrandrine
tetrandrine TID for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosed with critical COVID-19 pneumonia
Time Frame: 84 days
Diagnosed with COVID-19 pneumonia according to the criteria and meeting one of the following conditions: a. respiratory failure requiring mechanical ventilation, b. shock, c. other organ dysfunction requiring ICU management.
84 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Principal Investigator: Yongchang Sun, M.D., Peking University 3rd Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 31, 2023

Primary Completion (Estimated)

December 12, 2025

Study Completion (Estimated)

December 12, 2025

Study Registration Dates

First Submitted

January 21, 2023

First Submitted That Met QC Criteria

January 21, 2023

First Posted (Actual)

January 25, 2023

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2023002

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on Tetrandrine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe