Clinical trial NCT04391179: Dipyridamole to Prevent Coronavirus Exacerbation of Respiratory Status (DICER) in COVID-19
Official title: Dipyridamole to Prevent Coronavirus Exacerbation of Respiratory Status (DICER) in COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID
Corona Virus Infection
Covid-19
SARS-CoV-2 Infection
Keywords: Oxygen
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.


Eligibility 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
* 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

Primary outcomes:
measure: Percent Change in D-dimer
timeFrame: baseline, up to approximately 14 days after last study drug administration
measure: Number of Participants With Wins at Each Level of a Hierarchical Composite Rank Score
timeFrame: up to approximately 30 days after hospital discharge
Secondary outcomes:
measure: Days Alive and Free of Organ Support
timeFrame: up to approximately 28 days after last study drug administration score
measure: Individual Component of Composite Endpoint- Death
timeFrame: up to approximately 30 days after hospital discharge
measure: Individual Component of Composite Endpoint- Days on Mechanical Ventilation
timeFrame: up to 14 days after study drug administration
measure: Individual Component of Composite Endpoint- Sp02/Fi02 (as Shown by Participant Count)
timeFrame: up to 14 days after study drug administration
measure: Individual Component of Composite Endpoint- Cumulative Ordinal Score
timeFrame: Hospitalization up to 14 days after study drug administration
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jason Knight, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: