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Trial - NCT04410328


Column Value
Trial registration number NCT04410328
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

First author
Last imported at : Feb. 17, 2022, 5 p.m.
Source : ClinicalTrials.gov

Amit Singla, MD

Contact
Last imported at : Feb. 17, 2022, 5 p.m.
Source : ClinicalTrials.gov

as3321@njms.rutgers.edu

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

2020-06-01

Recruitment status
Last imported at : Feb. 17, 2022, 5 p.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

Open label

Center
Last imported at : Oct. 26, 2020, 11:31 p.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: age ≥18 years. hospitalization. sars-cov-2 viral nucleic acid positive within 3 days. lab test result pending plus a high clinical suspicion for sars-cov-2 (fever and cough for ≤ 7 days, bilateral pulmonary infiltrates on imaging or new hypoxemia with spo2 ≤94% on room air or no alternative explanation for respiratory symptoms). willing and able to provide consent or by authorized proxy.

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

pregnancy. g-6pd deficiency. use of antiplatelet agents including inhibitor of p2y12 adp platelet receptors, phosphodiesterase inhibitors, and glycoprotein iib/iiia inhibitors. on therapeutic anticoagulation with coumadin, heparin and direct oral anticoagulants. vasodilatory shock. patient with known ongoing angina, recent myocardial infarction and sub-valvular aortic stenosis. active gastric or duodenal ulcer or any bleeding disorder. hemoglobin <9 mg/dl, platelet count of <30,000 /mm3. acute respiratory infection for >10 days. known allergy/hypersensitivity to dipyridamole and/or aspirin. severe hepatic or renal insufficiency. uncontrolled hypertension defined as systolic > 180 mm hg or diastolic > 100 mm hg. patients with known allergy to nsaids

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

Rutgers, The State University of New Jersey

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

19

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/critical disease at enrollment

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

7: Severe/critical disease at enrollment

Total sample size
Last imported at : Feb. 17, 2022, 5 p.m.
Source : ClinicalTrials.gov

99

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

Covid (Coronavirus Disease-19) Ordinal Scale

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 3

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

[{"arm_notes": "", "treatment_id": 1487, "treatment_name": "Aspirin+dipyridamole", "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"}]