Clinical trial NCT05381363: Inhaled Interferon α2b Treatment in Mild-to-moderate COVID-19 Infected Children
Official title: Inhaled Interferon α2b Treatment in Mild-to-moderate COVID-19 Infected Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: COVID-19
Children
Keywords: interferon α2b
Inhaled treatment
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
name: Shanghai Children's Hospital
name: Shanghai Children's Medical Center, affiliated to Shanghai Jiao Tong University School of Medicine
First posted: 2022-05-19
Enrollment: 24
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Days requiring isolation (DRI)
timeFrame: from symptom onset to point of de-isolation (about 2-3 weeks)
Secondary outcomes:
measure: Duration of fever
timeFrame: from fever onset to free from fever (about 2-3 weeks)
measure: Proportions of COVID-19 symptoms
timeFrame: from symptom onset to point of de-isolation (about 2-3 weeks)
measure: Blood test
timeFrame: Every 3 days (from the date of hospitalization to point of de-isolation)
measure: C-reactive protein (CRP)
timeFrame: Every 3 days (from the date of hospitalization to point of de-isolation)
measure: Interleukin 6 (IL-6)
timeFrame: Every 3 days (from the date of hospitalization to point of de-isolation)
measure: Chest imaging findings
timeFrame: once on admission
measure: Number of Adverse Events (Abnormal Appearance)
timeFrame: From Day 1 to time point of de-isolation post-dose in each period (about 2-3 weeks)
measure: Number of Adverse Events (Abnormal Hematology)
timeFrame: From Day 1 to time point of de-isolation post-dose in each period (about 2-3 weeks)
measure: Number of Adverse Events (Abnormal Clinical Chemistry)
timeFrame: From Day 1 to time point of de-isolation post-dose in each period (about 2-3 weeks)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children Hospital of Fudan University
Study officials:
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