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Column | Value |
---|---|
Trial registration number | NCT05381363 |
Full text link
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
|
First author
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
|
Contact
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
zwhchfu@126.com |
Registration date
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
2022-05-19 |
Recruitment status
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
Recruiting |
Study design
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
RCT |
Allocation
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
Randomized |
Design
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
Parallel |
Masking
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
Open label |
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
Study aim
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
Treatment |
Inclusion criteria
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
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
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
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. |
Number of arms
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
2 |
Funding
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
Children's Hospital of Fudan University |
Inclusion age min
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
1 |
Inclusion age max
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
18 |
Countries
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
China |
Type of patients
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
Mild/moderate disease at enrollment |
Severity scale
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
2: Mild/moderate disease at enrollment |
Total sample size
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
200 |
primary outcome
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
Days requiring isolation (DRI) |
Notes
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
None |
Phase
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
Phase 1/Phase 2 |
Arms
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 667, "treatment_name": "Interferon alpha2b", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |