Clinical trial

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

Name

CHFudanU_COVID19-1

Description

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.

Trial arms

Trial start

2022-01-01

Estimated PCD

2023-01-01

Trial end

2023-01-01

Status

Terminated

Phase

Early phase I

Treatment

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

Arms:

Intervention: Inhaled Interferon α2b

Other names:

IFN α2b

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

Arms:

Intervention: Standard of Care

Other names:

Size

Primary endpoint

Days requiring isolation (DRI)

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

Eligibility 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}

Updated at

2023-12-29

1 organization

1 product

2 indications

Organization

Children's Hospital of Fudan University

Product

Interferon α2b

Indication

COVID-19

Indication

Childhood