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Tetrandrine Tablets Used in Hospitalized Adults With COVID-19

Primary Purpose

COVID-19

Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Tetrandrine
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Sign informed consent form voluntarily for the trial. Male or female aged between 18 and 85 years (inclusive). Clinically or laboratory confirmed COVID-19 within the past 7 days, as determined by a positive RT-PCR test or a positive antigen test. Under resting conditions, oxygen saturation ≤93% when breathing air, or P/F value ≤ 300 mmHg (1 mmHg = 0.133 kPa). No birth plan and must agree to take effective contraceptive methods. Exclusion Criteria: 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. Patient must be on invasive mechanical ventilation/ECMO at baseline. Any clinically important serious diseases unstable or uncontrolled. Allergy history to any biological or other agent. Patient has severe mental or psychological abnormalities, cognitive impairment or intellectual disability before being diagnosed with COVID-19. Subjects who are pregnant or breastfeeding, or plan to become pregnant during the study. Investigator think the subject should not participate in the study.

Sites / Locations

  • Peking University Third Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

tetrandrine group

placebo group

Arm Description

Tetrandrine 60mg TID for 28 days

placebo TID for 28 days

Outcomes

Primary Outcome Measures

Diagnosed with critical COVID-19 pneumonia
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.

Secondary Outcome Measures

Full Information

First Posted
January 21, 2023
Last Updated
January 21, 2023
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05697029
Brief Title
Tetrandrine Tablets Used in Hospitalized Adults With COVID-19
Official Title
Tetrandrine Tablets Used in Hospitalized Adults With COVID-19: a Double-blind, Placebo-controlled, Randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 31, 2023 (Anticipated)
Primary Completion Date
December 12, 2024 (Anticipated)
Study Completion Date
December 12, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
414 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tetrandrine group
Arm Type
Experimental
Arm Description
Tetrandrine 60mg TID for 28 days
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
placebo TID for 28 days
Intervention Type
Drug
Intervention Name(s)
Tetrandrine
Intervention Description
tetrandrine TID for 28 days
Primary Outcome Measure Information:
Title
Diagnosed with critical COVID-19 pneumonia
Description
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.
Time Frame
84 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sign informed consent form voluntarily for the trial. Male or female aged between 18 and 85 years (inclusive). Clinically or laboratory confirmed COVID-19 within the past 7 days, as determined by a positive RT-PCR test or a positive antigen test. Under resting conditions, oxygen saturation ≤93% when breathing air, or P/F value ≤ 300 mmHg (1 mmHg = 0.133 kPa). No birth plan and must agree to take effective contraceptive methods. Exclusion Criteria: 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. Patient must be on invasive mechanical ventilation/ECMO at baseline. Any clinically important serious diseases unstable or uncontrolled. Allergy history to any biological or other agent. Patient has severe mental or psychological abnormalities, cognitive impairment or intellectual disability before being diagnosed with COVID-19. Subjects who are pregnant or breastfeeding, or plan to become pregnant during the study. Investigator think the subject should not participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongchang Sun, M.D.
Phone
86-15611963697
Email
suny@bjmu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongchang Sun, M.D.
Organizational Affiliation
Peking University 3rd Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tetrandrine Tablets Used in Hospitalized Adults With COVID-19

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