NCT04366778: COVBIO

Thrombosis and Covid-19

Completed Last updated 25 January 2021

What this trial tests

trial testing TEM-tPA in Thrombosis in 341 participants. Completed in 1 January 2021.

Timeline

1 May 2020

Primary endpoint
1 January 2021

1 January 2021

Quick facts

Lead sponsor	Hospices Civils de Lyon
Status	Completed
Study type	OBSERVATIONAL
Enrollment	341
Start date	1 May 2020
Primary completion	1 January 2021
Estimated completion	1 January 2021
Sites	1 location across France

Drugs / interventions tested

• TEM-tPA

Conditions studied

• Thrombosis — all drugs for Thrombosis →
• Covid-19 — all drugs for Covid-19 →
• SARS-CoV 2 — all drugs for SARS-CoV 2 →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with Thrombosis or Covid-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The coronavirus disease of 2019 (COVID-19) is a viral illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), now deemed a pandemic by the World Health Organization. Some COVID-19 patients may develop coagulopathy which is associated with poor prognosis and high risk of thrombosis. Some patients develop severe thrombotic complications, such as pulmonary embolism, despite anti-thrombotic prophylaxis by low molecular weight heparin. The aim of this project is to evaluate modified thromboelastometry for identifying patients at high risk of thrombosis. The hypothesize is that hypofibrinolysis with increased plasma PAI-1, TAFI (thrombin-activatable fibrinolysis inhibitor ) levels in association with high thrombin generation may explain high incidence of thrombosis in this population. A simple laboratory assay, widely available in hospitals, such as thromboelastometry, might be of great clinical interest to detect Covid-19 patients with high risk of thrombosis. In order to make ROTEM more sensitive to hypofibrinolysis, exogenous t-PA will be added in the assay. The preliminary results showed that patients with Covid-19 have significant hypercoagulability detectable with ROTEM and Covid-19 patients with thrombosis have both hypercoagulability and hypofibrinolysis.

Publications & conference data

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

1. The hypercoagulable state in COVID-19: Incidence, pathophysiology, and management.
   Abou-Ismail MY, Diamond A, Kapoor S, Arafah Y, et al · · 2020 · cited 465× · PMID 32788101 · DOI 10.1016/j.thromres.2020.06.029
2. Hypofibrinolytic state and high thrombin generation may play a major role in SARS-COV2 associated thrombosis.
   Nougier C, Benoit R, Simon M, Desmurs-Clavel H, et al · · 2020 · cited 222× · PMID 32668058 · DOI 10.1111/jth.15016