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Trial - NCT04365309


Column Value
Trial registration number NCT04365309
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

First author
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Cai Yue

Contact
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-04-28

Recruitment status
Last imported at : March 13, 2022, midnight
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.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 : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: the patient volunteered to participate in the study, approved the aspirin treatment, and was willing to randomly accept one of the aspirin treatment regimens, and provided written informed consent, subject is required to meet one of the following criteria for confirmation of a novel coronavirus infection with pneumonia: 1.the detection of novel coronavirus nucleic acid is positive in respiratory or blood specimens by real-time -pcr, 2. virus gene sequencing of respiratory or blood specimen is highly homologous with known novel coronavirus, chest image confirmed pulmonary involvement; fever: ≥36.7℃ under the armpit, ≥38.0℃ in the oral cavity or ≥38.6℃ in the rectum and eardrum; • respiratory frequency ≥24 times/min or at least one cough; onset time ≤14 days; agree not to participate in another study until completion of the 14-day study; if you need to withdraw from this study; the subjects had not taken aspirin for nearly one month prior to the screening period. can follow the study or follow up procedure. -

Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

women who have recently been pregnant or breast-feeding. having a history of active gastrointestinal bleeding in the past 3 months. blood routine examination showed that the platelet count was < 30×109/l. patients with coagulation disorders. unable to understand the potential risks and benefits of the study, and unable to follow up the evaluation as required. having no capacity for civil conduct. a history of drug or alcohol abuse. allergic to aspirin. influenza virus, parainfluenza virus, adenovirus, respiratory syncytial virus, rhinovirus, human partial lung virus, mycoplasma pneumoniae, chlamydia pneumonia, bacterial pneumonia, organized pneumonia, etc. patients with cardiac stent placement (< 1 year). any more complex medical problems that may interfere with research behavior or lead to increased risk, such as malignant tumors, blood diseases, liver diseases, aids, viral hepatitis, etc.

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Xijing Hospital

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

85

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

China

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

128

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

clinical recovery time (TTCR);the time of SARS-CoV2 overcasting

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2/Phase 3

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 129, "treatment_name": "Aspirin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]