Phase 2 N=99 Randomized Single-blind Treatment

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

COVID · Corona Virus Infection · Covid-19 · SARS-CoV-2 Infection

Bottom Line

View on ClinicalTrials.gov: NCT04391179 ↗

Enrolled (actual)

Serious AEs

44.4%

Results posted

Mar 2022

Primary outcome: Primary: Percent Change in D-dimer — -5.6; -2.4 percent daily change — p=0.24

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Dipyridamole 100 Milligram(mg) (Drug); Placebo oral tablet (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Feb 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in D-dimer	-5.6; -2.4	0.24
PRIMARY Number of Participants With Wins at Each Level of a Hierarchical Composite Rank Score	0; 3; 3; 4; 13; 11	.98
SECONDARY Days Alive and Free of Organ Support	28; 28	.08
SECONDARY Individual Component of Composite Endpoint- Death	0; 3	.09
SECONDARY Individual Component of Composite Endpoint- Days on Mechanical Ventilation	0.33; 0.88	0.36
SECONDARY Individual Component of Composite Endpoint- Sp02/Fi02 (as Shown by Participant Count)	14; 14	.94
SECONDARY Individual Component of Composite Endpoint- Cumulative Ordinal Score	14.3; 15.0	.95

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04391179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.