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Trial record 10 of 49 for:    dipyridamole

Dipyridamole to Prevent Coronavirus Exacerbation of Respiratory Status (DICER) in COVID-19 (DICER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04391179
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Yogendra Kanthi, University of Michigan

Brief Summary:

The most severe manifestations of COVID-19 include respiratory failure, coagulation problems, and death. Inflammation and blood clotting are believed to play an important role in these manifestations. Research in humans has shown that dipyridamole can reduce blood clotting. This research study is being conducted to learn whether 14 days of treatment with dipyridamole will reduce excessive blood clotting in COVID-19.

This study will enroll participants with confirmed coronavirus (SARS-CoV)-2 infection that are admitted to University of Michigan. Eligible participants will be randomized to receive dipyridamole or placebo for 14 days in the hospital. In addition, data will be collected from the medical record, and there will also be blood draws during the hospitalization.


Condition or disease Intervention/treatment Phase
COVID Corona Virus Infection Covid-19 SARS-CoV-2 Infection Drug: Dipyridamole 100 Milligram(mg) Drug: Placebo oral tablet Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Dipyridamole to Prevent Coronavirus Exacerbation of Respiratory Status (DICER) in COVID-19
Actual Study Start Date : May 31, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dipyridamole 100 Milligram(mg)
100 milligrams (mg) by mouth (PO) four times a day (QID)
Drug: Dipyridamole 100 Milligram(mg)
Drug will be given for 14 days while in the hospital.

Placebo Comparator: Placebo
Placebo given by mouth four times a day
Drug: Placebo oral tablet
Placebo will be given for 14 days while in the hospital.




Primary Outcome Measures :
  1. Change in D-dimer [ Time Frame: baseline, up to approximately 28 days after last study drug administration ]
    Increase in plasma D-dimer level compared with baseline at enrollment.


Secondary Outcome Measures :
  1. Global composite rank score [ Time Frame: up to approximately 28 days after last study drug administration ]
    Global composite rank score of death, mechanical ventilation, oxygen saturation (SpO2)/fraction of inspired oxygen (FiO2), and World Health Organization (WHO) Ordinal score.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, enrolled ≤ 72 hours of hospital admission or of COVID-19 confirmation
  • Currently hospitalized or anticipated hospitalization requiring supplemental oxygen ≤ 6 liters per minute (LPM) by nasal cannula

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04391179


Contacts
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Contact: Neha Shah 734-232-4606 neshah@umich.edu
Contact: Yogendra Kanthi, MD 734-998-7955 ykanthi@umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Neha Shah    734-232-4606    neshah@umich.edu   
Sponsors and Collaborators
Yogendra Kanthi
Investigators
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Principal Investigator: Yogendra Kanthi, MD University of Michigan
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Responsible Party: Yogendra Kanthi, Assistant Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT04391179    
Other Study ID Numbers: HUM00179783
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yogendra Kanthi, University of Michigan:
Oxygen
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Dipyridamole
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents