Dipyridamole to Prevent Coronavirus Exacerbation of Respiratory Status (DICER) in COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Number of Participants With Wins at Each Level of a Hierarchical Composite Rank Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
Placebo given by mouth four times a day
干预措施: Placebo oral tablet (Drug)
Dipyridamole 100 Milligram(mg)
100 milligrams (mg) by mouth (PO) four times a day (QID)
干预措施: Dipyridamole 100 Milligram(mg) (Drug)
结局指标
主要结局
Number of Participants With Wins at Each Level of a Hierarchical Composite Rank Score
时间窗: 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.
Percent Change in D-dimer
时间窗: baseline, up to approximately 14 days after last study drug administration
average percent daily change in plasma D-dimer levels compared to baseline
次要结局
- Days Alive and Free of Organ Support(up to approximately 28 days after last study drug administration score)
- Individual Component of Composite Endpoint- Days on Mechanical Ventilation(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)
- Individual Component of Composite Endpoint- Death(up to approximately 30 days after hospital discharge)
- Individual Component of Composite Endpoint- Sp02/Fi02 (as Shown by Participant Count)(up to 14 days after study drug administration)
研究者
Jason Scott Knight
Associate Professor of Internal Medicine
University of Michigan