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Trial - NCT04435015


Column Value
Trial registration number NCT04435015
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04435015

First author
Last imported at : May 20, 2022, 9 a.m.
Source : ClinicalTrials.gov

Arya Mani

Contact
Last imported at : May 20, 2022, 9 a.m.
Source : ClinicalTrials.gov

not reported

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

2020-06-17

Recruitment status
Last imported at : May 20, 2022, 9 a.m.
Source : ClinicalTrials.gov

Withdrawn

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 : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

unclear

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: . positive covid-19 test result. diagnosis of covid-19 associated coagulopathy and cardiac complications based on d-dimer, fibrinogen, tnt, ctpe, ischemic ekg changes provision of informed consent. in patients with altered mental status consents can be obtained from the power of attorney. stated willingness to comply with all study procedures and availability for the duration of the study male or female, age 18 or older diagnosed with hypoxia requiring intubation or positive air pressure. diagnose with dvt/pe by ultrasound and ctpe and/or elevated d-dimer and/or greater than 2-fold increase in tnt ischemic ekg changes with st depression or elevation more than 1 mm in 2 consecutive leads ability to administer oral medication.

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

gfr<30 ml/min severe bleeding requiring blood transfusion of drop of 5% in hct. pregnancy or lactation known allergic reactions to components of camostat mesylate. subjects under age 18

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

Yale 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

None

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

Moderate/severe/critical disease at enrollment

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

5: Moderate/severe/critical disease at enrollment

Total sample size
Last imported at : May 20, 2022, 9 a.m.
Source : ClinicalTrials.gov

0

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

Percent change in plasma D-Dimer

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 1/Phase 2

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

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 245, "treatment_name": "Camostat mesilate", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]