Tetrandrine Tablets Used in Hospitalized Adults With COVID-19

NCT05697029 | Withdrawn Phase 4

• 1 other identifier: M2023002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

tetrandrine group

EXPERIMENTAL

Tetrandrine 60mg TID for 28 days

Drug: Tetrandrine

placebo group

PLACEBO COMPARATOR

placebo TID for 28 days

Drug: Tetrandrine

Interventions

Tetrandrine DRUG

tetrandrine TID for 28 days

placebo group; tetrandrine group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, 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 Officials

• Yongchang Sun, M.D.

  Peking University 3rd Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2023
• First Posted: January 25, 2023
• Study Start: December 31, 2023
• Primary Completion: December 12, 2025
• Study Completion: December 12, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)