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The Efficacy and Safety of Thalidomide in the Adjuvant Treatment of Moderate New Coronavirus (COVID-19) Pneumonia

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: NCT04273529
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 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.


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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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 in the Adjuvant Treatment of Moderate New Coronavirus (COVID-19) Pneumonia: a Prospective, Multicenter, Randomized, Double-blind, Placebo, Parallel Controlled Clinical Study
Estimated Study Start Date : February 20, 2020
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Thalidomide

Arm Intervention/treatment
Placebo Comparator: Control group
placebo
Drug: placebo
100mg,po,qn,for 14 days.

Experimental: Thalidomide group
thalidomide
Drug: thalidomide
100mg,po,qn,for 14 days.
Other Name: fanyingting




Primary Outcome Measures :
  1. Time to Clinical recoveryTime to Clinical Recovery (TTCR) [ Time Frame: up to 28 days ]

    TTCR is defined as the time (in hours) from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 72 hours. Normalisation and alleviation criteria:

    Fever - ≤36.6°C or -axilla, ≤37.2 °C oral or ≤37.8°C rectal or tympanic, Respiratory rate - ≤24/minute on room air, Oxygen saturation - >94% on room air, Cough - mild or absent on a patient reported scale of severe, moderate, mild, absent.



Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: up to 28 days ]
    baseline SpO2 during screening, PaO2/FiO2 <300mmHg or a respiratory rate ≥ 24 breaths per min without supplemental oxygen

  2. Frequency of respiratory progression [ Time Frame: up to 28 days ]
    Defined as SPO2≤ 94% on room air or PaO2/FiO2 <300mmHg and requirement for supplemental oxygen or more advanced ventilator support.

  3. Time to defervescence [ Time Frame: up to 28 days ]
    in those with fever at enrolment


Other Outcome Measures:
  1. Time to cough reported as mild or absent [ Time Frame: up to 28 days ]
    in those with cough at enrolment rated severe or moderate

  2. Respiratory improvement time [ Time Frame: up to 28 days ]
    patients with moderate / severe dyspnea when enrolled

  3. Frequency of requirement for supplemental oxygen or non-invasive ventilation [ Time Frame: up to 28 days ]
  4. Time to 2019-nCoV RT-PCR negative in upper respiratory tract specimen [ Time Frame: up to 28 days ]
  5. Change (reduction) in 2019-nCoV viral load in upper respiratory tract specimen as assessed by area under viral load curve [ Time Frame: up to 28 days ]
  6. Frequency of requirement for mechanical ventilation [ Time Frame: up to 28 days ]
  7. Frequency of serious adverse events [ Time Frame: up to 28 days ]
  8. 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. 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.

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): NCT04273529


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

Publications of Results:
Other Publications:

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Responsible Party: First Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT04273529    
Other Study ID Numbers: 20200214-COVID-19-M-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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents