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

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: 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

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.

Condition or disease Intervention/treatment Phase
COVID-19 Recombinant Human Interferon α1β Drug: Recombinant human interferon α1β Early Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 328 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : March 1, 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: Interferon

Arm Intervention/treatment
Experimental: Standard therapy + interferon therapy
Standard treatment + recombinant human interferon α1β 10ug Bid was administered by nebulization for 10 days.
Drug: Recombinant human interferon α1β
Saline needle 2ml + recombinant human interferon α1β10ug bid nebulization inhalation

No Intervention: Standard therapy + blank therapy
Standard therapy



Primary Outcome Measures :
  1. The incidence of side effects [ Time Frame: Within 14 days after enrollment ]
    dyspnea

  2. The incidence of side effects [ Time Frame: Within 14 days after enrollment ]
    SPO2≤94%

  3. The incidence of side effects [ Time Frame: Within 14 days after enrollment ]
    respiratory rate ≥24 breaths/min in oxygen state)


Secondary Outcome Measures :
  1. 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;

  2. Proportion of patients with normal body [ Time Frame: Within 14 days after enrollment ]
    Proportion of patients with normal body

  3. Proportion of patients without dyspnea [ Time Frame: Within 14 days after enrollment ]
    Proportion of patients without dyspnea

  4. Proportion of patients without cough [ Time Frame: Within 14 days after enrollment ]
    Proportion of patients without cough

  5. Proportion [ Time Frame: Within 14 days after enrollment ]
    Proportion of patients without oxygen treatment

  6. 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

  7. Proportion [ Time Frame: within 28 days after enrollment ]
    Proportion of patients hospitalized/hospitalized in ICU

  8. Frequency of serious adverse drug events. [ Time Frame: within 28 days after enrollment ]
    Frequency of serious adverse drug events.



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. 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.

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): NCT04293887


Contacts
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Contact: Jianping Zhao, Ph.D. 13507138234 Zhaojp88@126.com
Contact: Huilan Zhang, Ph.D. 15391532171 huilanz_76@163.com

Sponsors and Collaborators
Tongji Hospital
Additional Information:
Publications of Results:
Other Publications:

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Responsible Party: Zhao Jianping, Director of Respiratory and Critical Care Medicine , Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Tongji Hospital
ClinicalTrials.gov Identifier: NCT04293887    
Other Study ID Numbers: Zhaojp
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents