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

Phase 2TerminatedNCT05381363

Children's Hospital of Fudan University24 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COVID-19 Children

Interventions

Inhaled Interferon α2bDRUG

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

Standard of CareOTHER

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

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Children Hospital of Fudan University

Shanghai, China

Outcomes

Primary Outcomes

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.

Time frame: from symptom onset to point of de-isolation (about 2-3 weeks)

Secondary Outcomes

Duration of fever

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

Time frame: 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.

Time frame: 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.

Time frame: Every 3 days (from the date of hospitalization to point of de-isolation)

C-reactive protein (CRP)

Inflammatory Biomarker

Time frame: Every 3 days (from the date of hospitalization to point of de-isolation)

Interleukin 6 (IL-6)

Inflammatory Biomarker

Time frame: Every 3 days (from the date of hospitalization to point of de-isolation)

Chest imaging findings

Imaging evaluation methods

Data from ClinicalTrials.gov

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