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Trial - NCT04435184


Column Value
Trial registration number NCT04435184
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04435184

First author
Last imported at : Dec. 24, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Charles Lowenstein, MD

Contact
Last imported at : Dec. 24, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

clowens1@jhmi.edu

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

2020-06-17

Recruitment status
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Completed

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

Blind 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: willing to provide written informed consent willing to comply with all study procedures and be available for the duration of the study male or female ≥ 18 years of age sars-cov-2 infection (covid-19) within the past 10 d documented by laboratory test (nucleic acid test (nat) or reverse transcriptase-polymerase chain reaction (rt-pcr)) currently hospitalized symptoms of acute respiratory infection (at least one of the following: cough, fever > 37.5°c, dyspnea, sore throat, anosmia), radiographic evidence of pulmonary infiltrates requiring supplemental oxygen or the peripheral capillary oxygenation saturation (spo2) < 94% on room air at screening elevated d-dimer > 0.49 mg/l negative pregnancy test for females of childbearing potential

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

use of home oxygen at baseline current use of mechanical ventilation inability to provide consent do not intubate status prisoner or incarcerated pregnancy or breast feeding participation in other interventional therapy trials for covid-19. international normalized ratio (inr) > 3 or activated partial thromboplastin time (aptt) > 60

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

Johns Hopkins University

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

100

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

United States

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

Severe disease at enrollment

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

6: Severe disease at enrollment

Total sample size
Last imported at : Nov. 11, 2021, 4:30 p.m.
Source : ClinicalTrials.gov

54

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

Soluble P-selectin level

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

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

[{"arm_notes": "", "treatment_id": 355, "treatment_name": "Crizanlizumab", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]