In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (2019-nCoV) from these pneumonia patients and developed a real-time reverse transcription PCR (real time RT-PCR) diagnostic assay. 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. Thalidomide has anti-inflammatory, anti-fibrotic, anti-angiogenesis, and immune regulation effects. This study is the first Prospective, Multicenter, Randomized, Double-blind, Placebo, Parallel Controlled Clinical Study at home and abroad to use immunomodulators to treat patients with COVID-19 infection.
The new coronavirus (COVID-19) [1] belongs to the new beta coronavirus. Current research
shows that it has 85% homology with bat SARS-like coronavirus (bat-SL-CoVZC45), but its
genetic characteristics are similar to SARSr-CoV. There is a clear difference from MERSr-COV.
Since December 2019, Wuhan City, Hubei Province has successively found multiple cases of
patients with pneumonia infected by a new type of coronavirus. With the spread of the
epidemic, as of 12:00 on February 12, 2020, a total of 44726 confirmed cases nationwide
(Hubei Province) 33,366 cases, accounting for 74.6%), with 1,114 deaths (1068 cases in Hubei
Province), and a mortality rate of 2.49% (3.20% in Hubei Province).
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. Thalidomide has anti-inflammatory, anti-fibrotic, anti-angiogenesis, and immune
regulation effects. In the early clinical practice of treating severe A H1N1, it was
clinically concerned, and combined with hormones and conventional treatment, and achieved
good results.
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. This study is the first study at home and
abroad to use immunomodulators to treat patients with COVID-19 infection. It is hoped that
the patients can get out of the bitter sea as soon as possible and provide effective
solutions for the country and society.
Drug: thalidomide
100mg，po，qn，for 14 days.
Other Name: fanyingting
Drug: placebo
100mg，po，qn，for 14 days.
Inclusion Criteria:
1. Age ≥18 years;
2. Laboratory (RT-PCR) diagnosis of common patients infected with COVID-19 (refer to the
fifth edition of the Chinese Guidelines for Diagnosis and Treatment);
3. chest imaging confirmed lung damage;
4. The diagnosis is less than or equal to 8 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. Positive pregnancy or breastfeeding or 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