Tenecteplase in Patients With COVID-19

Status Completed

Clinical Trial Summary

This is a placebo-controlled, double blind, randomized, Phase II dose escalation study intended to evaluate the potential safety and efficacy of tenecteplase for the treatment of COVID-19 associated respiratory failure. The hypothesis is that administration of the drug, in conjunction with heparin anticoagulation, will improve patients' clinical outcomes.

Clinical Trial Description

Patients with COVID-19 who suffer from acute hypoxemic respiratory failure have a poor prognosis. COVID-19 has been associated with a hyperinflammatory and hypercoagulable state, leading to a range of thromboembolic complications from pulmonary embolism to ischemic stroke. Furthermore, emerging data suggest that the associated acute respiratory failure is, at least in part, due to pulmonary vascular disease caused by micro- and/or macro-emboli, creating pulmonary vascular shunting and dead-space ventilation. In this placebo-controlled, double blind, randomized, Phase II dose escalation study, we plan to evaluate the clinical efficacy and safety of low-dose IV bolus tenecteplase together with anticoagulation compared with control patients on therapeutic anticoagulation alone in hospitalized adults diagnosed with COVID-19 respiratory failure with elevated D-dimer. We believe these patients can be successfully treated without significantly increasing the risk of major bleeding while improving recovery rates, shorten hospitalization time, and perhaps ultimately prove to improve survival. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04505592
Study type	Interventional
Source	Icahn School of Medicine at Mount Sinai
Contact
Status	Completed
Phase	Phase 2
Start date	September 25, 2020
Completion date	March 10, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06065033` - Exercise Interventions in Post-acute Sequelae of Covid-19	N/A
Completed	`NCT06267534` - Mindfulness-based Mobile Applications Program	N/A
Completed	`NCT05047601` - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection	Phase 2/Phase 3
Recruiting	`NCT04481633` - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection	N/A
Recruiting	`NCT05323760` - Functional Capacity in Patients Post Mild COVID-19	N/A
Completed	`NCT04612972` - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru	Phase 3
Completed	`NCT04537949` - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults	Phase 1/Phase 2
Recruiting	`NCT05494424` - Cognitive Rehabilitation in Post-COVID-19 Condition	N/A
Active, not recruiting	`NCT06039449` - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2	Phase 3
Enrolling by invitation	`NCT05589376` - You and Me Healthy
Completed	`NCT05158816` - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting	`NCT04341506` - Non-contact ECG Sensor System for COVID19
Completed	`NCT04384445` - Zofin (Organicell Flow) for Patients With COVID-19	Phase 1/Phase 2
Completed	`NCT04512079` - FREEDOM COVID-19 Anticoagulation Strategy	Phase 4
Active, not recruiting	`NCT05975060` - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.	Phase 2/Phase 3
Active, not recruiting	`NCT05542862` - Booster Study of SpikoGen COVID-19 Vaccine	Phase 3
Withdrawn	`NCT05621967` - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation	N/A
Terminated	`NCT05487040` - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease	Phase 1
Terminated	`NCT04498273` - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80	Phase 3
Active, not recruiting	`NCT06033560` - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure