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

NCT04391179 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: HUM00179783
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Oxygen

Outcome Measures

Primary Outcomes (2)

• Percent Change in D-dimer

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

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

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

  Compare each dipyridamole patient head to head against each placebo patient using a hierarchical composite rank score 1. death 2. days on mechanical ventilation 3. dichotomized (yes/no) decrease in daily average SpO2/FiO2 of at least 50 units relative to day 1 at anytime during the observation period 4. 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.

  up to approximately 30 days after hospital discharge

Secondary Outcomes (5)

• Days Alive and Free of Organ Support

  up to approximately 28 days after last study drug administration score

• Individual Component of Composite Endpoint- Death

  up to approximately 30 days after hospital discharge

• Individual Component of Composite Endpoint- Days on Mechanical Ventilation

  up to 14 days after study drug administration

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

  up to 14 days after study drug administration

• Individual Component of Composite Endpoint- Cumulative Ordinal Score

  Hospitalization up to 14 days after study drug administration

Study Arms (2)

Dipyridamole 100 Milligram(mg)

EXPERIMENTAL

100 milligrams (mg) by mouth (PO) four times a day (QID)

Drug: Dipyridamole 100 Milligram(mg)

Placebo

PLACEBO COMPARATOR

Placebo given by mouth four times a day

Drug: Placebo oral tablet

Interventions

Dipyridamole 100 Milligram(mg) DRUG

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

Dipyridamole 100 Milligram(mg)

Placebo oral tablet DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Fischer AL, Messer S, Riera R, Martimbianco ALC, Stegemann M, Estcourt LJ, Weibel S, Monsef I, Andreas M, Pacheco RL, Skoetz N. Antiplatelet agents for the treatment of adults with COVID-19. Cochrane Database Syst Rev. 2023 Jul 25;7(7):CD015078. doi: 10.1002/14651858.CD015078.

  PMID: 37489818 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Jason Knight, MD, PhD
• Organization: University of Michigan

jsknight@med.umich.edu

734-763-3031

Study Officials

• Jason Knight, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 18, 2020
• Study Start: May 31, 2020
• Primary Completion: February 22, 2021
• Study Completion: February 22, 2021
• Last Updated: March 24, 2022
• Results First Posted: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)