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

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Fudan University
• Collaborators: RenJi Hospital; Shanghai Children's Hospital; Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine
• Treatments: Interferons

Criteria

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.