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 with severe COVID-19 have rapid disease progression and high mortality. There is currently no effective treatment method, which may be related to the excessive immune response caused by cytokine storm. This study will evaluate thalidomide combined with low-dose hormone adjuvant therapy for severe COVID-19 Patient effectiveness and safety.
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 a young severe patient. After the addition of thalidomide, the
reported 35 patients did not Deaths. Subsequent basic research at Fudan University confirmed
that thalidomide can treat H1N1 lung injury. And think that the combination with antiviral
drugs may be a better alternative strategy for H1N1 before the vaccine is successfully
developed.
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 with severe COVID-19 have rapid disease progression and high mortality.
There is currently no effective treatment method, which may be related to the excessive
immune response caused by cytokine storm.It has been reported that the combined use of
thalidomide and dexamethasone can effectively inhibit NK / T-cell lymphoma combined with
ECSIT V140A mutation of hematophilic syndrome. The AIDS immune reconstitution syndrome (IRIS)
is also an abnormal inflammatory response in nature. It has been reported that thalidomide as
an immunomodulatory agent for the treatment of IRIS is effective. This study will evaluate
thalidomide combined with low-dose hormone adjuvant therapy for severe COVID-19 Patient
effectiveness and safety.
Although the death rate of COVID-19 infected persons is not high, their rapid infectiousness
and the lack of effective antiviral treatment currently have become the focus of the national
and international epidemic. Thalidomide has been available for more than sixty years, and has
been widely used in clinical applications. It has been proved to be safe and effective in
IPF, severe H1N1 influenza lung injury and paraquat poisoning lung injury, and the mechanism
of anti-inflammatory and anti-fibrosis is relatively clear. As the current research on
COVID-19 at home and abroad mainly focuses on the exploration of antiviral efficacy, this
study intends to find another way to start with host treatment in the case that antiviral is
difficult to overcome in the short term, in order to control or relieve lung inflammation
caused by the virus To improve lung function.
Drug: placebo
100mg/d，qn，for 14 days.
Drug: Thalidomide
100mg/d，qn，for 14 days.
Other Name: fanyingting
Inclusion Criteria:
1. Age ≥18 years;
2. 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
3. The diagnosis is less than or equal to 12 days;
Exclusion Criteria:
1. 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)
2. Pregnancy or breastfeeding or positive pregnancy test;
3. 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);
4. Those with a history of thromboembolism, except for those caused by PICC.
Jinglin Xia, MD
0577-55578166
xiajinglin@fudan.edu.cn
Jinglin Xia, MD, Principal Investigator
First Affiliated Hospital of Wenzhou Medical University