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

December 27, 2023 updated by: Children's Hospital of Fudan University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 201102
        • Children Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days requiring isolation (DRI)
Time Frame: 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.
from symptom onset to point of de-isolation (about 2-3 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of fever
Time Frame: from fever onset to free from fever (about 2-3 weeks)
Efficacy of inhaled Interferon α2b by assessment of the duration of fever.
from fever onset to free from fever (about 2-3 weeks)
Proportions of COVID-19 symptoms
Time Frame: 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.
from symptom onset to point of de-isolation (about 2-3 weeks)
Blood test
Time Frame: 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.
Every 3 days (from the date of hospitalization to point of de-isolation)
C-reactive protein (CRP)
Time Frame: Every 3 days (from the date of hospitalization to point of de-isolation)
Inflammatory Biomarker
Every 3 days (from the date of hospitalization to point of de-isolation)
Interleukin 6 (IL-6)
Time Frame: Every 3 days (from the date of hospitalization to point of de-isolation)
Inflammatory Biomarker
Every 3 days (from the date of hospitalization to point of de-isolation)
Chest imaging findings
Time Frame: once on admission
Imaging evaluation methods
once on admission
Number of Adverse Events (Abnormal Appearance)
Time Frame: 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.
From Day 1 to time point of de-isolation post-dose in each period (about 2-3 weeks)
Number of Adverse Events (Abnormal Hematology)
Time Frame: 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.
From Day 1 to time point of de-isolation post-dose in each period (about 2-3 weeks)
Number of Adverse Events (Abnormal Clinical Chemistry)
Time Frame: 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.
From Day 1 to time point of de-isolation post-dose in each period (about 2-3 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Collaborators

RenJi Hospital
Shanghai Children's Hospital
Shanghai Children's Medical Center, affiliated to Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

May 18, 2022

First Submitted That Met QC Criteria

May 18, 2022

First Posted (Actual)

May 19, 2022

Study Record Updates

Last Update Posted (Actual)

December 29, 2023

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHFudanU_COVID19-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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