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

Fudan University

Status and phase: Terminated; Phase 2; Phase 1

Conditions: COVID-19; Children

Treatments: Other: Standard of Care; Drug: Inhaled Interferon α2b

Study type: Interventional

Funder types: Other

Identifiers

NCT05381363

CHFudanU_COVID19-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 12 months to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Intervention: Inhaled Interferon α2b

Experimental group

Description:

Inhaled Interferon α2b (10U/ml)

Treatment:

Drug: Inhaled Interferon α2b

Intervention: Standard of Care

Other group

Description:

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

Treatment:

Other: Standard of Care