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Trial - NCT05381363


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

Wenhao Zhou, Doctor

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"}]