NCT05381363

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 12 Months – 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• COVID-19
• Children

Interventions

Type	Name	Description
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	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

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2022-05-19
• Last updated: 2023-12-29

Locations

1 site across 1 country: China