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

  • STATUS
    Recruiting
  • participants needed
    80
  • sponsor
    University of Michigan
Send
Updated on 5 August 2020
See if I qualify
clot
covid-19
SARS
respiratory failure
coagulopathy
coronavirus infection
blood clotting
hypercoagulability
acute respiratory syndrome (sars)
hypercoagulable state

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.

Details
Condition COVID, Corona Virus Infection, Covid 19, SARS-CoV-2 Infection
Age 18years - 100years
Treatment Placebo Oral Tablet, Dipyridamole 100 Milligram(mg)
Clinical Study IdentifierNCT04391179
SponsorUniversity of Michigan
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

clot
covid-19
SARS
respiratory failure
coagulopathy
coronavirus infection
blood clotting
hypercoagulability
acute respiratory syndrome (sars)
hypercoagulable state

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.