Dipyridamole to Prevent Coronavirus Exacerbation of Respiratory Status (DICER) in COVID-19 (DICER)
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|ClinicalTrials.gov Identifier: NCT04391179|
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : June 2, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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.
- 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.
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
|Contact: Neha Shahfirstname.lastname@example.org|
|Contact: Yogendra Kanthi, MDemail@example.com|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Neha Shah 734-232-4606 firstname.lastname@example.org|
|Principal Investigator:||Yogendra Kanthi, MD||University of Michigan|