Children, COVID-19
Conditions
Keywords
interferon α2b, Inhaled 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.
Interventions
DRUGInhaled 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
OTHERStandard 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
Sponsors
RenJi Hospital
Shanghai Children's Hospital
Shanghai Children's Medical Center, affiliated to Shanghai Jiao Tong University School of Medicine
Children's Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days requiring isolation (DRI) | from symptom onset to point of de-isolation (about 2-3 weeks) | Efficacy of inhaled Interferon α2b by assessment of the Days requiring isolation (DRI). Patients will receive daily PCR. Nasal swab specimens were collected by standard procedures performed by trained nurses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportions of COVID-19 symptoms | from symptom onset to point of de-isolation (about 2-3 weeks) | Efficacy of inhaled Interferon α2b by assessment of the duration of COVID-10 symptoms including fever, cough, sore throat, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell. |
| Blood test | Every 3 days (from the date of hospitalization to point of de-isolation) | This test including the count of leukocytes, neutrophils, lymphocytes, platelets, and hemoglobin in plasma. Inflammatory Biomarker. |
| C-reactive protein (CRP) | Every 3 days (from the date of hospitalization to point of de-isolation) | Inflammatory Biomarker |
| Interleukin 6 (IL-6) | Every 3 days (from the date of hospitalization to point of de-isolation) | Inflammatory Biomarker |
| Duration of fever | from fever onset to free from fever (about 2-3 weeks) | Efficacy of inhaled Interferon α2b by assessment of the duration of fever. |
| Number of Adverse Events (Abnormal Appearance) | From Day 1 to time point of de-isolation post-dose in each period (about 2-3 weeks) | This is a composition of obviously severe flu-like symptoms, including nausea, fatigue, weight loss. |
| Number of Adverse Events (Abnormal Hematology) | From Day 1 to time point of de-isolation post-dose in each period (about 2-3 weeks) | Safety of inhaled Interferon α2b by assessment of safety laboratory tests. |
| Number of Adverse Events (Abnormal Clinical Chemistry) | From Day 1 to time point of de-isolation post-dose in each period (about 2-3 weeks) | Safety of inhaled Interferon α2b by assessment of safety laboratory tests. |
| Chest imaging findings | once on admission | Imaging evaluation methods |
Countries
China
Outcome results
None listed