The Efficacy and Safety of Thalidomide Combined With Low-dose Hormones in the Treatment of Severe COVID-19
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|ClinicalTrials.gov Identifier: NCT04273581|
Recruitment Status : Not yet recruiting
First Posted : February 18, 2020
Last Update Posted : February 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 Thalidomide||Drug: placebo Drug: Thalidomide||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Efficacy and Safety of Thalidomide Combined With Low-dose Hormones in the Treatment of Severe New Coronavirus (COVID-19) Pneumonia: a Prospective, Multicenter, Randomized, Double-blind, Placebo, Parallel Controlled Clinical Study|
|Estimated Study Start Date :||February 18, 2020|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||May 30, 2020|
Placebo Comparator: Control group
α-interferon： nebulized inhalation, 5 million U or equivalent dose added 2ml of sterile water for injection, 2 times a day, for 7 days； Abidol, 200mg / time, 3 times a day, for 7 days; Methylprednisolone： 40mg, q12h， for 5 days. placebo：100mg/d，qn，for 14 days.
100mg/d，qn，for 14 days.
Experimental: Thalidomide group
α-interferon： nebulized inhalation, 5 million U or equivalent dose added 2ml of sterile water for injection, 2 times a day, for 7 days； Abidol, 200mg / time, 3 times a day, for 7 days; Methylprednisolone： 40mg, q12h， for 5 days. thalidomide：100mg/d，qn，for 14 days.
100mg/d，qn，for 14 days.
Other Name: fanyingting
- Time to Clinical Improvement (TTCI) [ Time Frame: up to 28 days ]TTCI is defined as the time (in days) from initiation of study treatment (active or placebo) until a decline of two categories from admission status on a six-category ordinal scale of clinical status which ranges from 1 (discharged) to 6 (death). Six-category ordinal scale: 6. Death; 5. ICU, requiring ECMO and/or IMV; 4. ICU/hospitalization, requiring NIV/ HFNC therapy; 3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC); 2. Hospitalization, not requiring supplemental oxygen; 1. Hospital discharge. Abbreviation: IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation; HFNC, High-flow nasal cannula.
- Clinical status [ Time Frame: days 7, 14, 21, and 28 ]Clinical status, assessed by the ordinal scale at fixed time points
- Time to Hospital Discharge OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours [ Time Frame: up to 28 days ]
- All cause mortality [ Time Frame: up to 28 days ]
- Duration (days) of mechanical ventilation [ Time Frame: up to 28 days ]
- Duration (days) of extracorporeal membrane oxygenation [ Time Frame: up to 28 days ]
- Duration (days) of supplemental oxygenation [ Time Frame: up to 28 days ]
- Length of hospital stay (days) [ Time Frame: up to 28 days ]
- Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens [ Time Frame: up to 28 days ]
- Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve. [ Time Frame: up to 28 days ]
- Frequency of serious adverse drug events [ Time Frame: up to 28 days ]
- Serum TNF-α, IL-1β, IL-2, IL-6, IL-7, IL-10, GSCF, IP10#MCP1, MIP1α and other cytokine expression levels before and after treatment [ Time Frame: up to 28 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04273581
|Contact: Jinglin Xia, MDfirstname.lastname@example.org|
|Principal Investigator:||Jinglin Xia, MD||First Affiliated Hospital of Wenzhou Medical University|