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Trial of Open Label Dipyridamole- In Hospitalized Patients With COVID-19 (TOLD)

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: NCT04424901
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Bruce Liang, UConn Health

Brief Summary:

Brief Summary:

The goal here is to evaluate dipyridamole in treating respiratory tract infection and circulatory dysfunction due to SARS-CoV-2 coronavirus in hospitalized CVID-19 patients.

Infection with SARS-CoV-2 causes human COVID-19 (HCoV-19). The infection is associated with a deleterious inflammatory response and a prothrombotic state in addition to tissue damage from direct viral entry and proliferation. Dipyridamole has anti-platelet and anti-inflammatory effects. The drug was recently demonstrated to have anti-SARS-Cov-2 effect primarily in vitro. The concentration causing anti-viral effect in vitro is within that in the blood of humans taking this drug. As an oral tablet, it has the advantage of easy administration.

Anti thrombotic, anti viral and anti inflammatory actions of this drug may be efficacious and safe in hospitalized subjects


Condition or disease Intervention/treatment Phase
COVID-19 Pneumonia Vascular Complications Drug: Dipyridamole Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Randomized Open Label Study Standard Care vs. Standard Care with Dipyridamole
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label Study of the Vascular and Microbiologic Efficacy of Dipyridamole Plus Standard Care vs. Standard Care in Hospitalized COVID19 Patients
Actual Study Start Date : May 3, 2020
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard Care

Hospitalized patients meeting screen criteria receive standard Hospital care from which clinical event and lab data are collected.

Day 3,6 & 9 research samples will be used for obtaining immunological profiles as well as metabolomic profiling and whole genome sequencing for discovery of new biomarkers/ genomic regions that confer increased susceptibility to infection and DIP treatment efficacy or safety. Other samples will be obtained for microbiome and viral analyses.

Data collection ends on day 9.

Experimental: Standard Care with Dipyridamole

For this arm, Dipyridamole 100 mg, tid is given for 7 days. Hospitalized patients meeting screen criteria receive standard Hospital care from which clinical event and lab data are collected.

Day 3,6 & 9 research samples will be used for obtaining immunological profiles as well as metabolomic profiling and whole genome sequencing for discovery of new biomarkers/ genomic regions that confer increased susceptibility to infection and DIP treatment efficacy or safety. Other samples will be obtained for microbiome and viral analyses.

Data collection ends on day 9.

Drug: Dipyridamole
Dipyridamole-100mg taken 3 times a day by mouth for 7 days.




Primary Outcome Measures :
  1. Coagulation system [ Time Frame: 9 days ]
    D-dimer and platelet count


Secondary Outcome Measures :
  1. Viral Detection [ Time Frame: 9 days ]
    Evaluate for a non-detection from nasopharyngeal swab and in stool


Other Outcome Measures:
  1. Survival [ Time Frame: 9 days ]
    Survival Status Alive

  2. Inflammatory Markers [ Time Frame: 9 days ]
    Change in the markers CRP/Ferritin

  3. Blood Markers [ Time Frame: 9 days ]
    Change in Lymphocyte Count/ Fibrinogen/Cardiac Troponin

  4. Coagulation Markers [ Time Frame: 9 days ]
    Change in PT, PTT

  5. Pulmonary Status [ Time Frame: 9 days ]
    Change in SpO2/ imaging

  6. Clinical Status [ Time Frame: 9 days ]
    Change in fever, cough, sputum



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  1. Adults ≥18 years of age.
  2. COVID-19 positive by PCR and hospitalized for respiratory infection with a range of respiratory severity as follows.

    Moderate ● Diagnosed with SARS-CoV-2 infection by standard RT-PCR assay or equivalent testing

    ● Symptoms of moderate illness with COVID-19, which could include:

    o Fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms; shortness of breath with exertion

    • Clinical signs suggestive of moderate illness with COVID-19, such as:

      o RR ≥ 20, HR ≥ 90, SaO2 ≥93% on room air or requires ≤2L oxygen by nasal cannula (NC) in order maintain SaO2 ≥93%, fever >38.3 Celsius

    • No clinical signs indicative of Severe or Critical Illness Severity

    Severe

    • Diagnosed with SARS-CoV-2 infection by standard RT-PCR assay or equivalent testing
    • Symptoms suggestive of severe systemic illness with COVID-19, which could include:

      o any symptom of Moderate Illness; shortness of breath at rest or respiratory distress

    • Clinical signs indicative of severe systemic illness with COVID-19, such as

      o RR ≥ 30, HR ≥ 125, requires > 2L oxygen by NC in order maintain SaO2 ≥93%, PaO2/FiO2 <300

    • No criteria for Critical Severity

    Critical ● Diagnosed with SARS-CoV-2 infection by standard RT-PCR assay or equivalent testing

    • Evidence of critical illness, defined by at least 1 of the following:

      • Respiratory failure defined based on resource utilization requiring at least 1 of the following:

        ◙, Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20L/min with fraction of delivered oxygen ≥0.5), noninvasive positive pressure ventilation, ECMO, or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation)

      • Shock (defined by SBP < 90 mm Hg, or Diastolic BP < 60 mm Hg or requiring vasopressors)
      • Multiple organ dysfunction/failure
  3. Able to give written informed consent in English to participate in the study by patient.

    -

Exclusion Criteria:

  • Exclusion Criteria:

    1. Inability to swallow or ingest oral medication in either tablet form or in suspension form.
    2. Patient is known to be pregnant
    3. Patients with a history of allergy or hypersensitivity to dipyridamole
    4. Patient is unable to consent -intubated, on mechanical ventilation
    5. Bleeding disorders (e.g. thrombocytopenia with platelet counts < 50,000)
    6. Existing severe medical illnesses unrelated to Covid-19 infection such as end stage heart, kidney, liver disorders;

      or hepatic insufficiency defined as liver enzymes ≥5 times upper limit normal if baseline is normal or 5 times baseline if baseline is abnormal.

      Metastatic cancer as well as those with severe coronary artery disease, unstable angina, STEMI, NSTEMI, hypotension (systolic blood pressure <90mmHg), myocarditis, bradycardia with resting heart rate less than 60 bpm, atrioventricular block without pacemaker.

      Those with myasthenia gravis and those treated with cholinesterase inhibitors

    7. Patient is enrolled in a clinical trial for another investigational drug designed to test for efficacy for SARS-CoV-2

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): NCT04424901


Contacts
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Contact: Patti Keltonic, RN 860-679-4903 keltonic@uchc.edu
Contact: Elizabeth Laska, RN 860-679-1707 laska@uchc.edu

Locations
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United States, Connecticut
UConn Health Recruiting
Farmington, Connecticut, United States, 06030
Contact: Patti Keltonic, RN    860-679-4903    keltonic@uchc.edu   
Contact: Elizabeth Laska, RN    860-679-1707    laska@uchc.edu   
Principal Investigator: Bruce Liang, MD         
Sub-Investigator: Mark Metersky, MD         
Sub-Investigator: Eric Mortensen, MD         
Sub-Investigator: Christopher Pickett, MD         
Sub-Investigator: Jeffrey Aeschlimann, PharmD         
Sub-Investigator: Kevin Dieckhaus, MD         
Sponsors and Collaborators
UConn Health
Investigators
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Principal Investigator: Bruce Liang, MD UConn Health
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Responsible Party: Bruce Liang, Professor of Medicine School of Medicine, UConn Health
ClinicalTrials.gov Identifier: NCT04424901    
Other Study ID Numbers: 20-192-2.F
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 11, 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
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Dipyridamole
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents