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| Column | Value |
|---|---|
| Trial registration number | NCT05017714 |
|
Full text link
Last imported at : Aug. 25, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Aug. 25, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Aug. 25, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Aug. 25, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
2021-08-24 |
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Recruitment status
Last imported at : Aug. 25, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
Not recruiting |
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Study design
Last imported at : Aug. 25, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Aug. 25, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Aug. 25, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Aug. 25, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : Aug. 25, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : Aug. 25, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria:1.patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives prior to initiation of any study procedures. 2.male or female, between 18 and 65 years of age at the time of consent. 3.laboratory-confirmed sars-cov-2 infection as determined by rt-pcr in nasopharyngeal or oropharyngeal swabs < 72 hours prior to enrollment. 4patients with asymptomatics or mild covid-19, including: patients with asymptomatic infections refer to those with positive testing results in etiological detection of sars-cov-2 in swabs, but without any relevant clinical manifestations, such as self-perceived or clinically identified symptoms or signs, including fever, cough and sore throat, and without any typical imaging features of covid-19 in their ct scans. patients with mild sars-cov-2 infections refer to those who are infected with sars-cov-2 presenting mild symptoms in accordance with diagnosis and treatment protocol for novel coronavirus pneumonia (trial revision 8): mild clinical symptoms, and no findings of pneumonia in chest ct images. - |
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Exclusion criteria
Last imported at : Aug. 25, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
1.patients classified into moderate, severe, and critical cases according to the diagnosis and treatment protocol for novel coronavirus pneumonia (trial 8th edition) 2.females who are breast-feeding, lactating, pregnant or intending to become pregnant 3.patients who are receiving any treatment with interferon or participating in other clinical studies of antiviral therapy. 4.patients who are unable to collaborate due to poor mental health, suffering from psychiatric illness, or incapable of controlling themselves or expressing clearly. 5.patients excluded in the opinion of the investigators. - |
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Number of arms
Last imported at : Aug. 25, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Aug. 25, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
Beijing 302 Hospital |
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Inclusion age min
Last imported at : Aug. 25, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Aug. 25, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
65 |
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Countries
Last imported at : Aug. 25, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
None |
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Type of patients
Last imported at : Aug. 25, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
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Severity scale
Last imported at : Aug. 25, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
|
Total sample size
Last imported at : Aug. 25, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
300 |
|
primary outcome
Last imported at : Aug. 25, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
Time of negative detection of SARS-CoV-2 RNA |
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Notes
Last imported at : Aug. 25, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Aug. 25, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
Phase 3 |
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Arms
Last imported at : Aug. 25, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 911, "treatment_name": "Novaferon", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |