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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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COVID-19, Children

Intervention / Treatment
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* Drug: Inhaled Interferon α2b
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: Inhaled Interferon α2b<br>Inhaled Interferon α2b (10U/ml) | Drug: Inhaled Interferon α2b<br>* 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<br>* Other names: IFN α2b;|
| Other: Intervention: Standard of Care<br>Standard of care treatment will be provided according to management guideline. | Other: Standard of Care<br>* 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<br>* Other names: SC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days requiring isolation (DRI) | 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 | 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 | 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 | 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) | Inflammatory Biomarker | Every 3 days (from the date of hospitalization to point of de-isolation) | 
| Interleukin 6 (IL-6) | Inflammatory Biomarker | Every 3 days (from the date of hospitalization to point of de-isolation) | 
| Chest imaging findings | Imaging evaluation methods | once on admission | 
| Number of Adverse Events (Abnormal Appearance) | 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) | 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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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interferon α2b, Inhaled treatment