Tetrandrine Tablets Used in Hospitalized Adults With COVID-19

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05697029
• Other study ID #: M2023002
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 31, 2023
• Est. completion date: December 12, 2025

Study information

• Verified date: November 2023
• Source: Peking University Third Hospital
• Contact: Yongchang Sun, M.D.
• Phone: 86-15611963697
• Email: suny[@]bjmu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 414
• Est. completion date: December 12, 2025
• Est. primary completion date: December 12, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Tetrandrine
tetrandrine TID for 28 days

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	84 days