Tetrandrine Tablets Used in Hospitalized Adults With COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2025-12-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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tetrandrine group

Tetrandrine 60mg TID for 28 days

Group Type EXPERIMENTAL

Tetrandrine

Intervention Type DRUG

tetrandrine TID for 28 days

placebo group

placebo TID for 28 days

Group Type PLACEBO_COMPARATOR

Tetrandrine

Intervention Type DRUG

tetrandrine TID for 28 days

Interventions

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Tetrandrine

tetrandrine TID for 28 days

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No