COVIDPhase 2DICERNCT04391179
Dipyridamole to Prevent Coronavirus Exacerbation of Respiratory Status (DICER) in COVID-19
A Phase 2 study testing Dipyridamole 100 Milligram(mg) in people with COVID and Corona Virus Infection, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Corona Virus Infection, Covid-19
- What is being tested?
- Dipyridamole 100 Milligram(mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2020to 22 Feb 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Dipyridamole 100 Milligram(mg), Placebo oral tablet
- Keywords
- Oxygen
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dipyridamole 100 Milligram(mg)Drug
Drug will be given for 14 days while in the hospital.
Placebo oral tabletDrug
Placebo will be given for 14 days while in the hospital.
| Study group | Role | What they receive |
|---|---|---|
| Dipyridamole 100 Milligram(mg) | Experimental | 100 milligrams (mg) by mouth (PO) four times a day (QID) Receives: Drug: Dipyridamole 100 Milligram(mg) |
| Placebo | Placebo comparator | Placebo given by mouth four times a day Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in D-dimer
average percent daily change in plasma D-dimer levels compared to baseline
Measured: 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
- death
- days on mechanical ventilation
- dichotomized (yes/no) decrease in daily average SpO2/FiO2 of at least 50 units relative to day 1 at anytime during the observation period
- 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.
Measured: up to approximately 30 days after hospital discharge
Secondary outcomes (5)
Days Alive and Free of Organ Support
Organ support is defined as receipt of invasive mechanical ventilation, vasopressor therapy, ECMO support, or dialysis.
Measured: up to approximately 28 days after last study drug administration score
Individual Component of Composite Endpoint- Death
Death of any cause during duration of study participation
Measured: up to approximately 30 days after hospital discharge
Individual Component of Composite Endpoint- Days on Mechanical Ventilation
The number of days spent on invasive mechanical ventilation during study hospitalization.
Measured: up to 14 days after study drug administration
Individual Component of Composite Endpoint- Sp02/Fi02 (as Shown by Participant Count)
Binary outcome indicating patients whose Sp02/Fi02 dropped 50 points relative to baseline at any time during hospitalization.
Measured: up to 14 days after study drug administration
Individual Component of Composite Endpoint- Cumulative Ordinal Score
Cumulative sum of WHO Ordinal Scale for Clinical Improvement scores during hospitalization or through 14 days after study drug administration, whichever occurs first. The WHO Ordinal Scale ranges from 1 (no limitation of activities) through 8 (death). By definition, hospitalized patients score 3 or higher on the scale. The equation can be written: Cumulative Ordinal Score = (days in hospital up to 14) x (average ordinal score during hospitalization). Higher scores represent a combination of worse outcomes and longer hospitalizations.
Measured: Hospitalization up to 14 days after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start31 May 2020
- Primary completion22 Feb 2021
- Study completion22 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Scott Knight, University of Michigan
- Investigators
- Jason Knight, MD, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391179
- Sponsor's protocol ID
- HUM00179783
- Acronym
- DICER
- Status last verified
- Mar 2022
- First submitted
- 15 May 2020
- Last updated
- 24 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37489818
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dipyridamole to Prevent Coronavirus Exacerbation of Respiratory Status (DICER) in COVID-19
- ClinicalTrials.gov ID
- NCT04391179
- Acronym / sponsor ID
- DICER / HUM00179783
- Conditions
- COVID, Corona Virus Infection, Covid-19, SARS-CoV-2 Infection
- Keywords
- Oxygen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 31 May 2020 (actual)
- Primary completion
- 22 Feb 2021 (actual)
- Study completion
- 22 Feb 2021 (actual)
- First posted
- 18 May 2020 (actual)
- Results
- Posted 24 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dipyridamole 100 Milligram(mg) | Experimental | Drug: Dipyridamole 100 Milligram(mg)100 milligrams (mg) by mouth (PO) four times a day (QID) |
| Placebo | Placebo comparator | Drug: Placebo oral tabletPlacebo given by mouth four times a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dipyridamole 100 Milligram(mg)Drug will be given for 14 days while in the hospital. | Drug | Dipyridamole 100 Milligram(mg) |
| Placebo oral tabletPlacebo will be given for 14 days while in the hospital. | Drug | Placebo |
Primary outcome
Percent Change in D-dimer
Time frame: baseline, up to approximately 14 days after last study drug administration
average percent daily change in plasma D-dimer levels compared to baseline
Number of Participants With Wins at Each Level of a Hierarchical Composite Rank Score
Time frame: up to approximately 30 days after hospital discharge
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.
5 secondary outcomes
Days Alive and Free of Organ Support
Time frame: up to approximately 28 days after last study drug administration score
Individual Component of Composite Endpoint- Death
Time frame: up to approximately 30 days after hospital discharge
Individual Component of Composite Endpoint- Days on Mechanical Ventilation
Time frame: up to 14 days after study drug administration
Individual Component of Composite Endpoint- Sp02/Fi02 (as Shown by Participant Count)
Time frame: up to 14 days after study drug administration
Individual Component of Composite Endpoint- Cumulative Ordinal Score
Time frame: Hospitalization up to 14 days after study drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37489818Fischer 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.
- Individual participant dataSharing planned: No
Related trials for COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Knight, MD, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dipyridamole 100 Milligram(mg) in people with COVID and Corona Virus Infection, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in D-dimer (time frame: baseline, up to approximately 14 days after last study drug administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04391179, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.