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

Sponsor
First Affiliated Hospital of Wenzhou Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04273529
Collaborator
Second Affiliated Hospital of Wenzhou Medical University (Other), Wenzhou Central Hospital (Other)
100
Enrollment
2
Arms
4.3
Anticipated Duration (Months)

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Feb 20, 2020
Anticipated Primary Completion Date :
May 30, 2020
Anticipated Study Completion Date :
Jun 30, 2020

Arms and Interventions

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 Names:
  • fanyingting

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to Clinical recoveryTime to Clinical Recovery (TTCR) [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 [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 [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 [up to 28 days]

      in those with fever at enrolment

    Other Outcome Measures

    1. Time to cough reported as mild or absent [up to 28 days]

      in those with cough at enrolment rated severe or moderate

    2. Respiratory improvement time [up to 28 days]

      patients with moderate / severe dyspnea when enrolled

    3. Frequency of requirement for supplemental oxygen or non-invasive ventilation [up to 28 days]

    4. Time to 2019-nCoV RT-PCR negative in upper respiratory tract specimen [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 [up to 28 days]

    6. Frequency of requirement for mechanical ventilation [up to 28 days]

    7. Frequency of serious adverse events [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 [up to 28 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • First Affiliated Hospital of Wenzhou Medical University
    • Second Affiliated Hospital of Wenzhou Medical University
    • Wenzhou Central Hospital

    Investigators

    • Principal Investigator: Jinglin Xia, MD, First Affiliated Hospital of Wenzhou Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    First Affiliated Hospital of Wenzhou Medical University
    ClinicalTrials.gov Identifier:
    NCT04273529
    Other Study ID Numbers:
    • 20200214-COVID-19-M-T
    First Posted:
    Feb 18, 2020
    Last Update Posted:
    Feb 21, 2020
    Last Verified:
    Feb 1, 2020
    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:
    COVID-19
    Pneumonia
    Thalidomide

    Study Results

    No Results Posted as of Feb 21, 2020