CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
Tenecteplase +1 moredrug
Likely dose
Tenecteplase 0.25 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04505592
NCT04505592Phase 2Completed

Tenecteplase With Concomitant Anticoagulation for Severe Acute Respiratory Failure in Patients With COVID-19

Hooman Poor·interventional·Posted Aug 10, 2020·Updated Apr 6, 2023

In Brief

A Phase 2 clinical trial evaluating Tenecteplase and Placebo for COVID-19 and 2 related conditions. Completed, enrolled 13 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedAug 10, 2020
Enrollment StartSep 25, 2020
Primary CompletionMar 10, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.9 years ago

Interventions

Tenecteplasedrug

First 20 patients randomized to treatment arm will receive 0.25 mg/kg of tenecteplase. Next 20 patients randomized to treatment arm will receive 0.50 mg/kg of tenecteplase. Both will receive concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.

Placebodrug

Patients will receive placebo with concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.