| Methods |
Trial design: proof‐of‐concept, single‐centre, single‐blinded, placebo‐controlled, randomised trial Type of publication: trial registry Setting: hospital Recruitment dates: between May 2020 and January 2021 Country: USA Language: English Number of centres: single‐centre Inclusion criteria: age ≥ 18 years, willing and able to provide informed consent prior to performing study procedures unless they have a legally authorised representative (LAR), confirmed coronavirus (SARS‐CoV‐2) infection, currently hospitalised or anticipated hospitalisation requiring supplemental oxygen Exclusion criteria: in the opinion of at least two physicians, unlikely to survive for > 48 hours from screening, concurrent enrolment in a clinical trial of a cytokine inhibitor (targeting IL‐6, 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 readings at least 4 hours apart, pregnant or breastfeeding, concurrent dual antithrombotic therapy (aspirin or P2Y12 inhibitor (e.g. clopidogrel, ticagrelor) plus anticoagulation to treat deep venous thrombosis or pulmonary embolism, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 5 times upper limit of normal, haemoglobin < 8 g/dl, or platelets < 50,000 per 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 registration number: NCT04391179 Date of trial registration: 18 May 2020 Prospective completion date: February 2022 |
| Outcomes |
Primary outcomes
Per cent change in D‐dimer (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 (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; a) death, b) days on mechanical ventilation, c) dichotomised (yes/no) decrease in daily average SpO2/FiO2 of at least 50 units relative to day 1 at anytime during the observation period, d) cumulative sum of COVID ordinal score during study hospitalisation.
Secondary outcomes
Days alive and free of organ support (up to approximately 28 days after last study drug administration score). Organ support is defined as receipt of invasive mechanical ventilation, vasopressor therapy, ECMO support, or dialysis Individual component of composite endpoint ‐ death (up to approximately 30 days after hospital discharge), death of any cause during duration of study participation 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). Binary outcome indicating patients whose Sp02/Fi02 dropped 50 points relative to baseline at any time during hospitalisation. Individual component of composite endpoint ‐ cumulative sum of WHO Ordinal Scale for Clinical Improvement scores during hospitalisation or through 14 days after study drug administration, whichever occurs first
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