Prasugrel in Severe COVID-19 Pneumonia (PARTISAN)
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ClinicalTrials.gov Identifier: NCT04445623 |
Recruitment Status : Unknown
Verified May 2020 by Azienda Ospedaliera Universitaria Integrata Verona.
Recruitment status was: Not yet recruiting
First Posted : June 24, 2020
Last Update Posted : June 26, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID19 Thrombosis | Drug: Prasugrel Hydrochloride 10 MG Oral Tablet Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 128 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Experimental phase 3 drug trial, randomized 1:1, double-blind, multicentre in patients treated with prasugrel vs placebo. |
Masking: | Double (Participant, Care Provider) |
Masking Description: | use of placebo tablets of the same shape, colour of the investigational drug. Identical time and route of administration. |
Primary Purpose: | Treatment |
Official Title: | Prasugrel in the Prevention of Severe SARS-CoV2 Pneumonia in Hospitalised Patients |
Estimated Study Start Date : | July 2020 |
Estimated Primary Completion Date : | October 2020 |
Estimated Study Completion Date : | January 2021 |

Arm | Intervention/treatment |
---|---|
Active Comparator: prasugrel hydrochloride
film-coated tablets of prasugrel hydrochloride (10 mg daily dose after loading dose of 60 mg)
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Drug: Prasugrel Hydrochloride 10 MG Oral Tablet
administration of prasugrel daily for 15 days |
Placebo Comparator: placebo
film-coated tablets of placebo (10 mg daily dose after loading dose of 60 mg)
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Drug: Placebo
administration of placebo daily for 15 days |
- P/F ratio at day 7 [ Time Frame: day 7 ]PaO2/FiO2 ratio (arterial oxygen tension divided by the fraction of inspired oxygen) detected after 7 days of treatment
- Daily P/F ratio [ Time Frame: 15 days ]PaO2/FiO2 ratio (arterial oxygen tension divided by the fraction of inspired oxygen) detected daily for 15 days
- Daily need for oxygen supply [ Time Frame: 15 days ]daily need for oxygen supply for 15 days
- Need for ICU [ Time Frame: day 15 and day 30 ]Number of patients requiring transfer to the intensive care unit (ICU) by treatment arm
- Death [ Time Frame: 15 day and day 30 ]death by day 15 and day 30 by treatment arm
- MOF [ Time Frame: day 15 and day 30 ]Multi-organ failure (MOF) by day 15 and day 30 assessed using sequential organ failure assessment score (SOFA) score (Units 0-4 better outcome, over 30 worse outcome) by treatment arm
- Discharge [ Time Frame: day 15 and day 30 ]Number of patients discharged after improvement by day 15 and day 30 by treatment arm
- Clinical progression of the disease SOFA score [ Time Frame: day 15 and day 30 ]Clinical progression of the disease evaluated by SOFA score (Units 0-6 better outcome, 15-24 worse outcome) by day 15 and day 30
- Clinical progression of the disease APACHE II [ Time Frame: day 15 and day 30 ]Clinical progression of the disease evaluated by Acute Physiology And Chronic Health Evaluation (APACHE II) score (Units 1-5 better outcome, over 30 worse outcome) by day 15 and day 30
- Venous thrombosis/ pulmonary embolism/thrombosis [ Time Frame: day 15 and day 30 ]Number of patients with venous thrombosis/ pulmonary embolism/thrombosis by day 15 and day 30
- Need for CT imaging [ Time Frame: day 15 ]Number of patients requiring computerized tomography (CT) imaging due to worsening of respiratory function by treatment arm
- Daily Temperature [ Time Frame: 15 days ]Body temperature measured twice daily for 15 days, C°
- Daily blood pressure [ Time Frame: 15 days ]Blood pressure measured twice daily for 15 days, mmHg
- Daily total blood count Hemoglobin [ Time Frame: 15 days ]Total blood count measured in venous blood for 15 days, Hemoglobin, g/L (cell/mcL
- Daily total blood count Red Blood Cells [ Time Frame: 15 days ]Total blood count measured in venous blood for 15 days, Red Blood cells (cell/mcL)
- Daily total blood count Leukocytes [ Time Frame: 15 days ]Total blood count measured in venous blood for 15 days, Leukocytes (cell/mcL)
- Daily total blood count Platelets [ Time Frame: 15 days ]Total blood count measured in venous blood for 15 days, platelets (cell/mcL)
- Daily indices of organ damage Liver [ Time Frame: 15 days ]ALT U/L in venous blood
- Indices of inflammation C-reactive protein [ Time Frame: day 1, 2, 7, 15 ]C-reactive protein microg/L in venous blood
- Indices of haemostasis PT [ Time Frame: day 1, 2, 7,15 ]PT ratio in venous blood by treatment arm
- Daily progression at imaging (chest-X-ray) [ Time Frame: 15 days ]progression of lung infiltrates as detected by chest-X-ray by treatment arm
- Major bleeding [ Time Frame: day 1, 2, 7, 15, 30 ]Major and/or clinically relevant bleeding according to International Society of Thrombosis and Haemostasis (ISTH) bleeding scale (Unit 0 better outcome, 4 worse outcome, 11 items) during treatment.
- Total bleeding [ Time Frame: day 1, 2, 7, 15, 30 ]Total bleeding according to International Society of Thrombosis and Haemostasis (ISTH bleeding) scale (Unit 0 better outcome, 4 worse outcome, 11 items) during treatment.
- Unexpected clinical or laboratory findings [ Time Frame: day 1, 2, 7, 15 ]Number of unexpected changes in clinical or laboratory findings not included in the predefined list of outcomes during treatment. .
- Indices of inflammation D-dimer [ Time Frame: day 1, 2, 7, 15 ]D-dimer microg/L in venous blood
- Indices of inflammation Fibrinogen [ Time Frame: day 1, 2, 7, 15 ]Fibrinogen g/L in venous blood
- Indices of inflammation IL-6 [ Time Frame: day 1, 2, 7, 15 ]Interleukin (IL)-6 pg/mL in venous blood by treatment arm
- Indices of inflammation IL-1 [ Time Frame: day 1, 2, 7, 15 ]Interleukin (IL)-1 pg/mL in venous blood by treatment arm
- Daily indices of organ damage kidney [ Time Frame: 15 days ]serum creatinine micromol/L by treatment arm
- Daily indices of organ damage heart [ Time Frame: 15 days ]troponin t ng/L by treatment arm
- Haemostasis aPTT [ Time Frame: day 1, 2, 7,15 ]aPTT ratio by treatment arm
- Haemostasis VASP PRI [ Time Frame: day 1, 2, 7,15 ]Vasodilator stimulated phosphoprotein (VASP) phosphorylation (PRI) % by treatment arm
- Haemostasis platelet-leukocytes aggregates [ Time Frame: day 1, 2, 7,15 ]Platelet-leukocytes aggregates % in peripheral by treatment arm

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 ischemic attack (TIA).
- Severe liver failure (Child-Pugh class C).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04445623
Contact: Pietro Minuz, Professor | 045-8124414 ext +39 | pietro.minuz@univr.it | |
Contact: Marco Cattaneo, Professor | 02-50323095 ext +39 | marco.cattaneo@unimi.it |
Italy | |
Azienda Ospedaliera Universitaria Integrata Verona | |
Verona, Italy, 37126 |
Responsible Party: | Azienda Ospedaliera Universitaria Integrata Verona |
ClinicalTrials.gov Identifier: | NCT04445623 |
Other Study ID Numbers: |
MGI-COVID-19-prasugrel |
First Posted: | June 24, 2020 Key Record Dates |
Last Update Posted: | June 26, 2020 |
Last Verified: | May 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
COVID-19 Pneumonia Thrombosis Respiratory Tract Infections Infections Pneumonia, Viral Virus Diseases Coronavirus Infections Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Prasugrel Hydrochloride Platelet Aggregation Inhibitors |