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The Efficacy and Safety of Thalidomide Combined With Low-dose Hormones in the Treatment of Severe COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04273581
Recruitment Status : Not yet recruiting
First Posted : February 18, 2020
Last Update Posted : February 21, 2020
Sponsor:
Collaborators:
Second Affiliated Hospital of Wenzhou Medical University
Wenzhou Central Hospital
Information provided by (Responsible Party):
First Affiliated Hospital of Wenzhou Medical University

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 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.

Condition or disease Intervention/treatment Phase
COVID-19 Thalidomide Drug: placebo Drug: Thalidomide Phase 2

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
Drug Information available for: Thalidomide

Arm Intervention/treatment
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.
Drug: placebo
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.
Drug: Thalidomide
100mg/d,qn,for 14 days.
Other Name: fanyingting




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Clinical status [ Time Frame: days 7, 14, 21, and 28 ]
    Clinical status, assessed by the ordinal scale at fixed time points

  2. Time to Hospital Discharge OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours [ Time Frame: up to 28 days ]
  3. All cause mortality [ Time Frame: up to 28 days ]
  4. Duration (days) of mechanical ventilation [ Time Frame: up to 28 days ]
  5. Duration (days) of extracorporeal membrane oxygenation [ Time Frame: up to 28 days ]
  6. Duration (days) of supplemental oxygenation [ Time Frame: up to 28 days ]
  7. Length of hospital stay (days) [ Time Frame: up to 28 days ]
  8. Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens [ Time Frame: up to 28 days ]
  9. 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 ]
  10. Frequency of serious adverse drug events [ Time Frame: up to 28 days ]
  11. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Jinglin Xia, MD 0577-55578166 xiajinglin@fudan.edu.cn

Sponsors and Collaborators
First Affiliated Hospital of Wenzhou Medical University
Second Affiliated Hospital of Wenzhou Medical University
Wenzhou Central Hospital
Investigators
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Principal Investigator: Jinglin Xia, MD First Affiliated Hospital of Wenzhou Medical University

Additional Information:
Publications:

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Responsible Party: First Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT04273581    
Other Study ID Numbers: 20200214-COVID-19-S-T
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thalidomide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents