Status:
UNKNOWN
The Efficacy and Safety of Thalidomide Combined With Low-dose Hormones in the Treatment of Severe COVID-19
Lead Sponsor:
First Affiliated Hospital of Wenzhou Medical University
Collaborating Sponsors:
Second Affiliated Hospital of Wenzhou Medical University
Wenzhou Central Hospital
Conditions:
COVID-19 Thalidomide
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Patients w...
Detailed Description
Thalidomide has been clinically reported, and combined with antiviral drugs and other conventional treatments have achieved good results in the treatment of severe H1N1, especially after the death of ...
Eligibility Criteria
Inclusion
- Age ≥18 years;
- The laboratory (RT-PCR) confirmed the diagnosis of severe patients infected with CoVID-19 (refer to the fifth edition of the Chinese diagnosis and treatment guideline for trial); the diagnosis of new coronavirus pneumonia was confirmed, and any of the following: 1) Respiratory distress, breathing ≥30 beats / min; 2) In the resting state, the oxygen saturation is ≤93%; 3) Arterial blood oxygen partial pressure / oxygen concentration ≤300mmHg
- The diagnosis is less than or equal to 12 days;
Exclusion
- Severe liver disease (such as Child Pugh score ≥ C, AST\> 5 times the upper limit); severe renal dysfunction (the glomerulus is 30ml / min / 1.73m2 or less)
- Pregnancy or breastfeeding or positive pregnancy test;
- In the 30 days before the screening assessment, have taken any experimental treatment drugs for CoVID-19 (including off-label, informed consent use or trial-related);
- Those with a history of thromboembolism, except for those caused by PICC.
Key Trial Info
Start Date :
February 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04273581
Start Date
February 18 2020
End Date
May 30 2020
Last Update
February 21 2020
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