COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04391179

Yogendra Kanthi, MD;Neha Shah

ykanthi@umich.edu

2020-05-18

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: willing and able to provide informed consent prior to performing study procedures unless they have a legally authorized representative (lar) confirmed coronavirus (sars-cov-2) infection currently hospitalized or anticipated hospitalization requiring supplemental oxygen

- in the opinion of at least two investigators, unlikely to survive for >48 hours from screening - concurrent enrollment in a clinical trial with a cytokine inhibitor (targeting interleukin-6 (il-6), interleukin-6 receptor (il-6r), il-1, or janus kinase). use of remdesivir is permitted. - currently on invasive mechanical ventilation. - hypotension defined as systolic blood pressure < 90 mmhg on two sequential readings at least 4 hours apart - pregnant or breastfeeding - concurrent dual antithrombotic therapy (aspirin or p2y12 inhibitor plus anticoagulation to treat deep venous thrombosis or pulmonary embolism (single antiplatelet or anticoagulant agent at prophylaxis or therapeutic dose is permitted) - aspartate aminotransferase (ast) or alanine aminotransferase (alt) greater than 5 times upper limit of normal, hemoglobin < 8 grams per deciliter (g/dl), or platelets <50,000 per cubic millimeter (mm3) - history of recent major bleeding, defined in accordance with the criteria of the international society on thrombosis and hemostasis (isth). - any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study

2

University of Michigan

18

None

United States

Severe disease at enrollment

6: Severe disease at enrollment

99

Number of Participants With Wins at Each Level of a Hierarchical Composite Rank Score;Percent Change in D-dimer

None

Phase 2

[{"arm_notes": "", "treatment_id": 411, "treatment_name": "Dipyridamole", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]