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Trial - NCT04899232


Column Value
Trial registration number NCT04899232
Full text link
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04899232

First author
Last imported at : April 13, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

Enrique Ginzburg

Contact
Last imported at : April 13, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

2021-05-24

Recruitment status
Last imported at : April 13, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

Terminated

Study design
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : May 26, 2021, 12:32 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 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Treatment

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

inclusion criteria: >18y of age, subject or proxy who can provide informed consent positive sars-cov-2 by polymerase chain reaction (pcr) or as determined by clinical team

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

adults or proxy unable to consent individuals who are not yet adults (infants, children, teenagers) pregnant women prisoners patients expected to die within 24 hours or with a "do not resuscitate" order, multi-organ failure, history of hypersensitivity or allergy to any component of the study drug, ongoing massive surgical or unexplained bleeding, history of bleeding or clotting disorder, severe traumatic brain injury (glasgow coma scale <6), spinal or multiple-trauma, cancer (incurable/terminal phase) and/or patients receiving palliative care, enrollment in another concurrent clinical interventional study if considered interfering with this study objectives per study team discretion, any condition(s) that may prevent safe treatment, preclude adequate evaluation or adding further risk to their underlying illness.

Number of arms
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Enrique Ginzburg

Inclusion age min
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

No restriction on type of patients

Severity scale
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

0: No restriction on type of patients

Total sample size
Last imported at : April 13, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

52

primary outcome
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Change in ISTH DIC Score

Notes
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : May 26, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 104, "treatment_name": "Antithrombin iii", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "2 groups;with endogenous Antithrombin III less than 100% vs more than 100%", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]