NCT04808895: Asperum

Acetylsalicylic Acid in the Prevention of Severe SARS-CoV2 Pneumonia in Hospitalised Patients With COVID-19

Status unknown Phase 3 Last updated 22 March 2021

What this trial tests

Phase 3 trial testing Acetylsalicylic acid in COVID-19 in 204 participants. Status unknown.

Timeline

1 April 2021

Primary endpoint
1 July 2021

31 August 2021

Quick facts

Lead sponsor	Azienda Ospedaliera Universitaria Integrata Verona
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	204
Start date	1 April 2021
Primary completion	1 July 2021
Estimated completion	31 August 2021
Sites	1 location across Italy

Drugs / interventions tested

• Acetylsalicylic acid (acetylsalicylic acid) — full drug profile →
• Placebo

Conditions studied

• COVID-19 — all drugs for COVID-19 →
• Thrombosis Pulmonary — all drugs for Thrombosis Pulmonary →

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona — full company profile →

Who can join

Adults 18 to 99, any sex, with COVID-19 or Thrombosis Pulmonary. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Inflammatory diseases favour the onset of venous thromboembolic events in hospitalized patients. Thromboprophylaxis with a fixed dose of heparin/low molecular weight heparin (LMWH) is recommended if concomitant inflammatory disease. In severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) pneumonia an inflammation-dependent thrombotic process occurs and platelet activation may promote thrombosis and amplify inflammation, as indicated by previous experimental evidence, and the similarities with atherothrombosis and thrombotic microangiopathies. Antiplatelet agents represent the cornerstone in the prevention and treatment of atherosclerotic arterial thromboembolism, with limited efficacy in the context of venous thromboembolism. The use of acetylsalicylic acid may improve inflammation and respiratory function in humans as indicated by the results of observational studies. There are no validated protocols for thrombosis prevention in Covid-19. There is scientific rationale to consider acetylsalicylic acid for the prevention of thrombosis in the pulmonary circulation and attenuation of inflammation. This is supported by numerous demonstrations of the anti-inflammatory activity of antiplatelet agents and the evidence of improvement in respiratory function both in human and experimental pathology. The hypothesis underlying the present study project is that in Covid-19 platelet activation occurs through an inflammation-dependent mechanism and that early antithrombotic prophylaxis in non-critical patients could reduce the incidence of pulmonary thrombosis and respiratory and multi-organ failure improving clinical outcome in patients with SARS-CoV2 pneumonia. The prevention of thrombogenic platelet activity with acetylsalicylic acid could be superior to fixed dose enoxaparin alone. The proposed treatment is feasible in all coronavirus disease 2019 (COVID-19) patients, regardless of the treatment regimen (antivirals, anti-inflammatory drugs), except for specific contraindications. To this aim, the investigators a randomised, placebo-controlled, double blind, parallel arms study to investigate the potential protection of acetylsalicylic acid towards the progression of lung failure in patients admitted to a medical ward for SARS-CoV-2 pneumonia. A 15-day treatment period is considered. Primary endpoint is the occurrence of one of the following events: admission to an intensive care unit, requirement of mechanical ventilation, PaO2/FiO2 less than 150 mm Hg.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Races of small molecule clinical trials for the treatment of COVID-19: An up-to-date comprehensive review.
   Hu S, Jiang S, Qi X, Bai R, et al · · 2022 · cited 68× · PMID 34762760 · DOI 10.1002/ddr.21895
2. The roles of lipids in SARS-CoV-2 viral replication and the host immune response.
   Theken KN, Tang SY, Sengupta S, FitzGerald GA. · · 2021 · cited 59× · PMID 34599996 · DOI 10.1016/j.jlr.2021.100129
3. Metabolic alterations upon SARS-CoV-2 infection and potential therapeutic targets against coronavirus infection.
   Chen P, Wu M, He Y, Jiang B, et al · · 2023 · cited 50× · PMID 37286535 · DOI 10.1038/s41392-023-01510-8
4. Aspirin as an Adjunctive Pharmacologic Therapy Option for COVID-19: Anti-Inflammatory, Antithrombotic, and Antiviral Effects All in One Agent.
   Tantry US, Schror K, Navarese EP, Jeong YH, et al · · 2021 · cited 15× · PMID 34908882 · DOI 10.2147/jep.s330776
5. Nonsteroidal anti-inflammatory drugs and glucocorticoids in COVID-19.
   Ricciotti E, Laudanski K, FitzGerald GA. · · 2021 · cited 11× · PMID 34303107 · DOI 10.1016/j.jbior.2021.100818
6. The central role of neutrophil extracellular traps (NETs) and by-products in COVID-19 related pulmonary thrombosis.
   Li S, Wang H, Shao Q. · · 2023 · cited 10× · PMID 37647446 · DOI 10.1002/iid3.949
7. Antiplatelet agents for the treatment of adults with COVID-19.
   Fischer AL, Messer S, Riera R, Martimbianco ALC, et al · · 2023 · cited 5× · PMID 37489818 · DOI 10.1002/14651858.cd015078
8. Lipid metabolism, viral infection, and antiviral immunity: a new host-pathogen interface.
   Yang LJ, Tang M, Yang L. · · 2026 · PMID 41868152 · DOI 10.3389/fcimb.2026.1765502