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Efficacy and Safety of IFN-α2β in the Treatment of Novel Coronavirus Patients

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ClinicalTrials.gov Identifier: NCT04293887
Recruitment Status : Not yet recruiting
First Posted : March 3, 2020
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Zhao Jianping, Tongji Hospital

Tracking Information
First Submitted Date  ICMJE February 15, 2020
First Posted Date  ICMJE March 3, 2020
Last Update Posted Date March 3, 2020
Estimated Study Start Date  ICMJE March 1, 2020
Estimated Primary Completion Date May 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2020)
  • The incidence of side effects [ Time Frame: Within 14 days after enrollment ]
    dyspnea
  • The incidence of side effects [ Time Frame: Within 14 days after enrollment ]
    SPO2≤94%
  • The incidence of side effects [ Time Frame: Within 14 days after enrollment ]
    respiratory rate ≥24 breaths/min in oxygen state)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2020)
  • Time from patient enrollment to clinical remission [ Time Frame: Within 14 days after enrollment ]
    the patient had a normal body temperature of > for 24 hours (without taking antipyretic drugs or hormones) without self-consciousness Dyspnea or reduced dyspnea;
  • Proportion of patients with normal body [ Time Frame: Within 14 days after enrollment ]
    Proportion of patients with normal body
  • Proportion of patients without dyspnea [ Time Frame: Within 14 days after enrollment ]
    Proportion of patients without dyspnea
  • Proportion of patients without cough [ Time Frame: Within 14 days after enrollment ]
    Proportion of patients without cough
  • Proportion [ Time Frame: Within 14 days after enrollment ]
    Proportion of patients without oxygen treatment
  • The negative conversion rate of new coronavirus nucleic acid [ Time Frame: Within 14 days after enrollment ]
    The negative conversion rate of new coronavirus nucleic acid
  • Proportion [ Time Frame: within 28 days after enrollment ]
    Proportion of patients hospitalized/hospitalized in ICU
  • Frequency of serious adverse drug events. [ Time Frame: within 28 days after enrollment ]
    Frequency of serious adverse drug events.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of IFN-α2β in the Treatment of Novel Coronavirus Patients
Official Title  ICMJE Randomized, Open, Blank Control Study on the Efficacy and Safety of Recombinant Human Interferon α1β in the Treatment of Patients With New Type of Coronavirus Infection in Wuhan
Brief Summary New coronavirus infection is an important cause of public health emergencies at home and abroad, which seriously affects people's health and social stability. The outbreak of SRAR-COV in China in 2003 caused serious social impact. From January 2002 to August 7, 2003, there were a total of 8,422 cases worldwide, involving 32 countries and regions, of which 919 cases were fatal, with a fatality rate of nearly 11%. The fatality rate of elderly patients and patients with underlying diseases was even more high.There is no precise and effective treatment for coronavirus infection. In vitro, IFN-α2β has inhibitory effects on MERS-CoV and closely related coronavirus severe acute respiratory syndrome (SARS) -CoV. A study showed the effects of interferon-α2β and ribavirin on the replication of nCoV isolates hCoV-EMC / 2012 in Vero and LLC-MK2 cells. The combined application may be useful for the management of patients with nCoV infection in the future. At present, the combination therapy of interferon α2β and ribavirin has been successfully applied in the initial treatment and prevention of SARS and MERS.The purpose of this study was to evaluate the efficacy and safety of recombinant human interferon α1β in treating patients with new coronavirus infection in Wuhan.
Detailed Description

This study is a multi-center, randomized, open, blank-controlled, multi-stage clinical study. As there are no effective treatments, the project team will evaluate possible treatments (including but not limited to interferon α) based on actual conditions. , Lopinavir / ritonavir, remdesivir, single / polyclonal antibodies against coronavirus), explore the most effective antiviral treatment options.

The first phase will assess the efficacy and safety of interferon alpha compared to standard treatment for approximately 328 hospitalized adult patients diagnosed with a new coronavirus infection in Wuhan.

Patients with COVID-19 within 7 days of onset of symptoms were screened and randomly assigned as soon as possible after screening (within 24 hours). Patients will be allocated in a 1: 1 ratio, receiving the interferon alpha treatment group or only the standard treatment group. Patients who do not meet the inclusion and exclusion criteria are only allowed to be re-screened once, provided that the time from symptom onset to randomization remains within 7 days.

This study planned to randomize approximately 328 adult subjects. It will be stratified according to whether the onset time is ≤ 3 days, and randomly divided into groups of 1: 1, receiving standard treatment or interferon alpha atomization twice a day, 1 stick (10ug) each time, treatment course For 10 days. Subjects and all research center staff were not blinded.

The primary endpoint of this study was the incidence of side effects within 14 days of enrollment. Therefore, a 14-day visit is essential for the data needed for this endpoint. Every effort should be made to ensure that this study visit is completed in a timely manner.

Out-of-hospital treatment or discharge will reach the discharge standard on the day of implementation and will be implemented in accordance with the Health and Medical Commission's "Unknown Viral Pneumonia Diagnosis and Treatment Plan (Trial)". For patients treated outside the hospital or who have been discharged, final assessments are performed by phone and using a questionnaire (if applicable).

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID-19
  • Recombinant Human Interferon α1β
Intervention  ICMJE Drug: Recombinant human interferon α1β
Saline needle 2ml + recombinant human interferon α1β10ug bid nebulization inhalation
Study Arms  ICMJE
  • Experimental: Standard therapy + interferon therapy
    Standard treatment + recombinant human interferon α1β 10ug Bid was administered by nebulization for 10 days.
    Intervention: Drug: Recombinant human interferon α1β
  • No Intervention: Standard therapy + blank therapy
    Standard therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 2, 2020)
328
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date May 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 18 years;
  2. Clinically diagnosed patients with new type of coronavirus pneumonia, including: in accordance with the criteria for suspected cases, have one of the following etiology evidence:

    ① Real-time fluorescence RT-PCR of respiratory specimens or blood specimens for detection of new coronavirus nucleic acid;

    ② Sequencing of viral genes in respiratory specimens or blood specimens, highly homologous to known new coronavirus

  3. The time interval between the onset of symptoms and random enrollment is within 7 days. The onset of symptoms is mainly based on fever. If there is no fever, cough, diarrhea or other related symptoms can be used.

Exclusion Criteria:

  1. Any situation where the programme cannot be carried out safely;
  2. Patients who have used interferon or remedesivir;
  3. No clinical manifestations and chest imaging findings
  4. Known allergy or hypersensitivity to interferon (including asthma);
  5. Disabled in patients with uncontrolled autoimmune diseases;
  6. Patients with severe heart disease, decompensated liver disease, renal insufficiency (CrCL <50ml / min), and those with abnormal bone marrow function are prohibited;
  7. Epilepsy and impaired central nervous system function;
  8. Pregnancy: Positive pregnancy test for women of childbearing age;
  9. Breastfeeding women have not stopped breastfeeding;
  10. The patient may be transferred to a non-participating hospital within 72 hours.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jianping Zhao, Ph.D. 13507138234 Zhaojp88@126.com
Contact: Huilan Zhang, Ph.D. 15391532171 huilanz_76@163.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04293887
Other Study ID Numbers  ICMJE Zhaojp
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zhao Jianping, Tongji Hospital
Study Sponsor  ICMJE Tongji Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tongji Hospital
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP