Tetrandrine Tablets Used in Hospitalized Adults With COVID-19

Phase 4

Withdrawn

• Conditions: COVID-19
• Interventions: Drug: Tetrandrine

• Registration Number: NCT05697029
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Study First Submitted: 2023-01-21
• Study First Submitted QC: 2023-01-21
• Study First Posted: 2023-01-25
• Study Start: 2023-12-31
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-28
• Last Update Posted: 2024-10-01
• Primary Completion: 2025-12-12
• Study Completion: 2025-12-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 414

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tetrandrine group	Tetrandrine	Tetrandrine 60mg TID for 28 days
placebo group	Tetrandrine	placebo TID for 28 days

Primary Outcome Measures

Name	Time	Method
Diagnosed with critical COVID-19 pneumonia	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.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China