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NCT Number: NCT04391179

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

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. 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.

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Key information

Conditions

COVID COVID-19 Corona Virus Infection Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sars-CoV-2 Infection Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Dipyridamole 100 Milligram(mg)

Drug

Drug will be given for 14 days while in the hospital.

Placebo oral tablet

Drug

Placebo will be given for 14 days while in the hospital.

Primary outcomes

  1. Percent Change in D-dimer

    Time frame: baseline, up to approximately 14 days after last study drug administration

    average percent daily change in plasma D-dimer levels compared to baseline

  2. Number of Participants With Wins at Each Level of a Hierarchical Composite Rank Score

    Time frame: up to approximately 30 days after hospital discharge

    Compare each dipyridamole patient head to head against each placebo patient using a hierarchical composite rank score

    • death
    • days on mechanical ventilation
    • dichotomized (yes/no) decrease in daily average SpO2/FiO2 of at least 50 units relative to day 1 at anytime during the observation period
    • cumulative sum of COVID ordinal score during study hospitalization. Ordinal scores could range 1-8. Levels 1 and 2 imply no hospitalization and 8 is the worst possible score (death); by definition, the subjects in the DICER study were hospitalized during the time period in which the study observed their ordinal scores.

Secondary outcomes

  1. Days Alive and Free of Organ Support

    Time frame: up to approximately 28 days after last study drug administration score

    Organ support is defined as receipt of invasive mechanical ventilation, vasopressor therapy, ECMO support, or dialysis.

  2. Individual Component of Composite Endpoint- Death

    Time frame: up to approximately 30 days after hospital discharge

    Death of any cause during duration of study participation

  3. Individual Component of Composite Endpoint- Days on Mechanical Ventilation

    Time frame: up to 14 days after study drug administration

    The number of days spent on invasive mechanical ventilation during study hospitalization.

  4. Individual Component of Composite Endpoint- Sp02/Fi02 (as Shown by Participant Count)

    Time frame: up to 14 days after study drug administration

    Binary outcome indicating patients whose Sp02/Fi02 dropped 50 points relative to baseline at any time during hospitalization.

  5. Individual Component of Composite Endpoint- Cumulative Ordinal Score

    Time frame: Hospitalization up to 14 days after study drug administration

    Cumulative sum of WHO Ordinal Scale for Clinical Improvement scores during hospitalization or through 14 days after study drug administration, whichever occurs first. The WHO Ordinal Scale ranges from 1 (no limitation of activities) through 8 (death). By definition, hospitalized patients score 3 or higher on the scale. The equation can be written: Cumulative Ordinal Score = (days in hospital up to 14) x (average ordinal score during hospitalization). Higher scores represent a combination of worse outcomes and longer hospitalizations.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Acronym: DICER

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 18, 2020
Registry last updated
Mar 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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