| Study name |
Prasugrel in Severe COVID‐19 Pneumonia (PARTISAN) |
| Methods |
Trial design: RCT, open‐label, phase 3 Type of publication: trial registry Setting: hospital Recruitment dates: not yet recruiting Country: Italy Language: English Number of centres: NR Inclusion criteria: COVID‐19 pneumonia, age over 18 years, willingness to express consent Exclusion criteria: active neoplasia or in maintenance therapy, pregnancy and breastfeeding, any absolute contraindication to the use of antiplatelet drugs, pathological bleeding in progress, recent major bleeding at any location, need to use therapeutic doses of oral anticoagulants or heparins, need to use antiplatelet in combination for clinical indication, hypersensitivity to the active substance prasugrel or any of the excipients, clinical history of stroke or transient ischaemic attack (TIA), severe liver failure (Child‐Pugh class C) Trial registration number: NCT04445623 Date of trial registration: 24 June 2020 Prospective completion date: January 2021 |
| Participants |
Age: 18 to 99 years Gender: NR Ethnicity: NR Number of participants (recruited/allocated/evaluated): 128/NR/NR Severity of disease: SARS‐CoV‐2 infection (COVID‐19) Additional diagnoses: thrombosis Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): NR |
| Interventions |
Active comparator: film‐coated tablets of prasugrel hydrochloride (10 mg daily dose after loading dose of 60 mg) orally once daily for 15 days Placebo comparator: film‐coated tablets of placebo orally once daily for 15 days
Concomitant therapy: NR Treatment cross‐overs: NR Duration of follow‐up: NR Treatment cross‐overs: NR Compliance with assigned treatment: NR
|
| Outcomes |
Primary outcomes
P/F ratio at day 7
Secondary outcomes
Daily P/F ratio Daily need for oxygen supply Need for ICU Death MOF Discharge Clinical progression of the disease SOFA score Clinical progression of the disease APACHE II Venous thrombosis/ pulmonary embolism/thrombosis Need for CT imaging Daily Temperature Daily blood pressure Daily total blood count Hemoglobin Daily total blood count Red Blood Cells Daily total blood count Leukocytes Daily total blood count Platelets Daily indices of organ damage Liver Indices of inflammation C‐reactive protein Indices of haemostasis PT Daily progression at imaging (chest‐X‐ray) Major bleeding Total bleeding Unexpected clinical or laboratory findings Indices of inflammation D‐dimer Indices of inflammation Fibrinogen Indices of inflammation IL‐6 Indices of inflammation IL‐1 Daily indices of organ damage kidney Daily indices of organ damage heart Haemostasis aPTT Haemostasis VASP PRI Haemostasis platelet‐leukocytes aggregates
Additional Outcomes: NR |
| Starting date |
1 July 2020 |
| Contact information |
Contact: Pietro Minuz, Professor 045‐8124414 ext +39 pietro.minuz@univr.it Contact: Marco Cattaneo, Professor 02‐50323095 ext +39 marco.cattaneo@unimi.it |
| Notes |
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