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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dipyridamole 100 Milligram(mg) | Experimental | 100 milligrams (mg) by mouth (PO) four times a day (QID) |
|
| Placebo | Placebo Comparator | Placebo given by mouth four times a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dipyridamole 100 Milligram(mg) | Drug | Drug will be given for 14 days while in the hospital. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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
| up to approximately 30 days after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Days Alive and Free of Organ Support | Organ support is defined as receipt of invasive mechanical ventilation, vasopressor therapy, ECMO support, or dialysis. | up to approximately 28 days after last study drug administration score |
| Individual Component of Composite Endpoint- Death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Knight, MD, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37489818 | Derived | 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. |
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Between May 2020 and January 2021, 99 eligible participants received at least one dose of study drug and were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dipyridamole 100 Milligram(mg) | 100 milligrams (mg) by mouth (PO) four times a day (QID) Dipyridamole 100 Milligram(mg): Drug will be given for 14 days while in the hospital. |
| FG001 | Placebo | Placebo given by mouth four times a day Placebo oral tablet: Placebo will be given for 14 days while in the hospital. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dipyridamole 100 Milligram(mg) | 100 milligrams (mg) by mouth (PO) four times a day (QID) Dipyridamole 100 Milligram(mg): Drug will be given for 14 days while in the hospital. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in D-dimer | average percent daily change in plasma D-dimer levels compared to baseline | Posted | Mean | 97.8% Confidence Interval | percent daily change | baseline, up to approximately 14 days after last study drug administration |
|
The collection period for adverse events began after informed consent and ended 30 days after administration of the last dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dipyridamole 100 Milligram(mg) | 100 milligrams (mg) by mouth (PO) four times a day (QID) Dipyridamole 100 Milligram(mg): Drug will be given for 14 days while in the hospital. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Knight, MD, PhD | University of Michigan | 734-763-3031 | jsknight@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 12, 2021 | Mar 10, 2022 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 3, 2022 | Mar 10, 2022 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| Placebo oral tablet | Drug | Placebo will be given for 14 days while in the hospital. |
|
Death of any cause during duration of study participation |
| 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. | 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. | 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. | Hospitalization up to 14 days after study drug administration |
Placebo given by mouth four times a day
Placebo oral tablet: Placebo will be given for 14 days while in the hospital.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| D-Dimer | Baseline plasma D-dimer level | Three patients did not have baseline D-Dimer values on the day of study drug. | Mean | Standard Deviation | mg/L |
|
| Oxygen Saturation (SpO2)/Fraction of Inspired Oxygen (FiO2) | Mean | Standard Deviation | ratio |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | 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
| Posted | Count of Participants | Participants | up to approximately 30 days after hospital discharge |
|
|
|
|
| Secondary | Days Alive and Free of Organ Support | Organ support is defined as receipt of invasive mechanical ventilation, vasopressor therapy, ECMO support, or dialysis. | 5 participants on dipyridamole and 2 participants on placebo were excluded from this analysis because of their early withdrawal from the study (prior to 28 days after last study drug administration). | Posted | Median | Inter-Quartile Range | days | up to approximately 28 days after last study drug administration score |
|
|
|
|
| Secondary | Individual Component of Composite Endpoint- Death | Death of any cause during duration of study participation | Posted | Count of Participants | Participants | up to approximately 30 days after hospital discharge |
|
|
|
|
| Secondary | Individual Component of Composite Endpoint- Days on Mechanical Ventilation | The number of days spent on invasive mechanical ventilation during study hospitalization. | Posted | Mean | Standard Deviation | days | up to 14 days after study drug administration |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | up to 14 days after study drug administration |
|
|
|
|
| Secondary | 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. | excluded patients that died or withdrew from the study | Posted | Median | Inter-Quartile Range | score on a scale * days | Hospitalization up to 14 days after study drug administration |
|
|
|
|
| 0 |
| 49 |
| 14 |
| 49 |
| 43 |
| 49 |
| EG001 | Placebo | Placebo given by mouth four times a day Placebo oral tablet: Placebo will be given for 14 days while in the hospital. | 3 | 50 | 30 | 50 | 15 | 50 |
| Delirium | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| Heart failure | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
| Lung infection | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
| Paroxysmal artrial tachycardia | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
| Pneumothorax | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Stroke | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Delirium | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Abdominal pain | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
|
| Epistaxis | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
| Heart failure | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
| Electrocardiogram QT corrected interval prolonged | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
| Edema limbs | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
| Kidney infection | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
| Atypical urothelial cells in urine | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
| Incontinence | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Emesis | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Vaginal hemorrhage | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Ankle pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Body pain | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Fall | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Diaphoresis | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Tremor | General disorders | CTCAE (5.0) | Systematic Assessment |
|
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| D007239 |
| Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Composite endpoint- 50+ unit drop SpO2/FiO2 |
|
| Composite endpoint- remaining (ties among patients evaluated by ordinal score) |
|