Tetrandrine Tablets Used in Hospitalized Adults With COVID-19
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: tetrandrine group Tetrandrine 60mg TID for 28 days |
Drug: Tetrandrine
tetrandrine TID for 28 days
|
| Placebo Comparator: placebo group placebo TID for 28 days |
Drug: Tetrandrine
tetrandrine TID for 28 days
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
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.
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Patient must be on invasive mechanical ventilation/ECMO at baseline.
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Any clinically important serious diseases unstable or uncontrolled.
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Allergy history to any biological or other agent.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University Third Hospital | Beijing | Beijing | China | 100191 |
Sponsors and Collaborators
- Peking University Third Hospital
Investigators
- Principal Investigator: Yongchang Sun, M.D., Peking University 3rd Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- M2023002