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Inhaled Interferon α2b Treatment in Mild-to-moderate COVID-19 Infected Children

Sponsor
Children's Hospital of Fudan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05381363
Collaborator
RenJi Hospital (Other), Shanghai Children's Hospital (Other), Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine (Other)
200
Enrollment
1
Location
2
Arms
2
Anticipated Duration (Months)
101.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In the COVID-19 pandemic era, a convenient and effective treatment for pediatric patients is unavailable. A multi-center Chinese clinical trials with the aim to using Interferon-α2b spray inhalation to develop new treatment strategies for the treatment of pediatric patients with mild or moderate type of COVID-19. The purpose of this study is to determine the safety and efficacy for Interferon α2b spray inhalation as first line treatment.

Condition or Disease Intervention/Treatment Phase
  • Drug: Inhaled Interferon α2b
  • Other: Standard of Care
 Phase 1/Phase 2

Detailed Description

This project aims to improve the treatment of pediatric patients infected with COVID-19. Interferon has antiviral property and is approved to be used in treatment in hepatitis B and hepatitis C virus infections. Interferon α2b, β1a and lambda are under evaluation in clinical trials for the treatment of COVID-19 in adult. As upper respiratory tract infection is the dominant characteristic of most infected children, topical treatment may be a better way to increase the safety and efficacy than oral or intravenous medication. This study aims to obtain essential data regarding the efficacy and safety of inhaled Interferon α2b in children with mild to moderate COVID-19 infection. Subjects will be enrolled with COVID-19 infection diagnoses by ORF1ab gene and N gene PCR test. Standard evaluation process will be applied to identify mild and moderate patients. Patients will be randomized into interferon group and non-interferon group. Patients in interferon group will receive inhalation treatment within the first five days since the symptom onset. Patients will receive daily PCR test. Cycle threshold (Ct) values over 35 is considered as de-isolation criterion. Days requiring isolation (from symptom onset to de-isolation time point) is the major index to evaluate efficacy. Clinical manifestations and test results from clinical recording system will be collected to evaluate the side effects.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Inhaled Interferon α2b Treatment in Mild-to-moderate COVID-19 Infected Children
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
May 14, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention: Inhaled Interferon α2b

Inhaled Interferon α2b (10U/ml)

Drug: Inhaled Interferon α2b
Drug: Inhaled Interferon α2b; 1-2 years old: 1 dose, three times per day; 3-7 years old: 1 dose, four times per day; 7-18 years old: 2 doses, four times per day
Other Names:
  • IFN α2b

    		•
    Other: Intervention: Standard of Care

    Standard of care treatment will be provided according to management guideline.

    Other: Standard of Care
    Standard of care treatment will be provided based on the New Coronavirus Pneumonia Prevention and Control guideline (9th edition), published by National Health Commission of China
    Other Names:
  • SC

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Days requiring isolation (DRI) [from symptom onset to point of de-isolation (about 2-3 weeks)]

      Efficacy of inhaled Interferon α2b by assessment of the Days requiring isolation (DRI). Patients will receive daily PCR. Nasal swab specimens were collected by standard procedures performed by trained nurses.

    Secondary Outcome Measures

    1. Duration of fever [from fever onset to free from fever (about 2-3 weeks)]

      Efficacy of inhaled Interferon α2b by assessment of the duration of fever.

    2. Proportions of COVID-19 symptoms [from symptom onset to point of de-isolation (about 2-3 weeks)]

      Efficacy of inhaled Interferon α2b by assessment of the duration of COVID-10 symptoms including fever, cough, sore throat, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell.

    3. Blood test [Every 3 days (from the date of hospitalization to point of de-isolation)]

      This test including the count of leukocytes, neutrophils, lymphocytes, platelets, and hemoglobin in plasma. Inflammatory Biomarker.

    4. C-reactive protein (CRP) [Every 3 days (from the date of hospitalization to point of de-isolation)]

      Inflammatory Biomarker

    5. Interleukin 6 (IL-6) [Every 3 days (from the date of hospitalization to point of de-isolation)]

      Inflammatory Biomarker

    6. Chest imaging findings [once on admission]

      Imaging evaluation methods

    7. Number of Adverse Events (Abnormal Appearance) [From Day 1 to time point of de-isolation post-dose in each period (about 2-3 weeks)]

      This is a composition of obviously severe flu-like symptoms, including nausea, fatigue, weight loss.

    8. Number of Adverse Events (Abnormal Hematology) [From Day 1 to time point of de-isolation post-dose in each period (about 2-3 weeks)]

      Safety of inhaled Interferon α2b by assessment of safety laboratory tests.

    9. Number of Adverse Events (Abnormal Clinical Chemistry) [From Day 1 to time point of de-isolation post-dose in each period (about 2-3 weeks)]

      Safety of inhaled Interferon α2b by assessment of safety laboratory tests.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Months to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients diagnosed as mild to moderate COVID-19 infection with positive PCR test and symptoms (Ct < 35)

    • Parents and patients comprehend and welling to participate in this study.

    • Agree to the collection of nasal swabs per day as protocol.

    Exclusion Criteria:

    • Patients evaluated as severe or critically severe type of COVID-19 infection (Individuals who have SpO2 <94% on room air, oxygen treatment is necessary, respiratory failure, septic shock, and/or multiple organ dysfunction).

    • Patients with comorbidities

    • Decline to participate by parents or children

    • Allergy to any study medication or usage of any kind of interferon treatment within 14 days before test

    • Children cannot tolerate the inhalation treatment

    • Any situation where the program cannot be carried out safely.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children Hospital of Fudan University Shanghai China 201102

    Sponsors and Collaborators

    • Children's Hospital of Fudan University
    • RenJi Hospital
    • Shanghai Children's Hospital
    • Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Children's Hospital of Fudan University
    ClinicalTrials.gov Identifier:
    NCT05381363
    Other Study ID Numbers:
    • CHFudanU_COVID19-1
    First Posted:
    May 19, 2022
    Last Update Posted:
    May 19, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Children's Hospital of Fudan University
    interferon α2b
    Inhaled treatment
    Additional relevant MeSH terms:
    COVID-19
    Interferons

    Study Results

    No Results Posted as of May 19, 2022