Status:
COMPLETED
Nebulised Rt-PA for ARDS Due to COVID-19
Lead Sponsor:
University College, London
Conditions:
COVID
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
Some patients infected with COVID-19 develop a severe form of a lung disease called acute respiratory distress syndrome (ARDS). In these patients, the lungs become severely inflamed because of the vir...
Detailed Description
This is a phase II, open label, uncontrolled, repeated dose, pilot trial of nebulised rt-PA in patients with COVID-19 ARDS. The study recruited patients requiring either invasive mechanical ventilati...
Eligibility Criteria
Inclusion
- Inclusion Criteria (cohorts 1 and 2):
- Patients with COVID-19 (confirmed by PCR or radiologically)
- ≥16 years
- Willing and able to provide written informed consent or where patient doesn't have capacity, consent obtained from a legal representative
- Patients on IMV must meet both the following criteria:
- PaO2/FiO2 of ≤ 300 (definition of ARDS)
- Intubated \> 6 hrs
- Patients not intubated must meet the following criteria:
- PaO2/FiO2 ≤ 300 or equivalent imputed by non-linear calculation from SpO2/FiO2 (see look-up table in appendices)
- In-patient \>6 hours and being actively treated
- On support with non-invasive ventilation OR continuous positive airway pressure (CPAP) OR high flow OR standard oxygen therapy
- Exclusion Criteria (cohort 1):
- Females who are pregnant
- Concurrent involvement in another experimental investigational medicinal product
- Known allergies to the IMP or excipients of IMP
- A pre-existing bleeding disorder (e.g. severe haemophilia) with no definitive treatment
- Pre-existing severe cardiopulmonary disease (e.g. incurable lung cancer, severe chronic obstructive lung disease, cardiomyopathy, heart failure or impaired contractility \<estimated 40% LVEF or RVEF)
- Fibrinogen \< 2.0 g/L at time of screening
- Patients considered inappropriate for active treatment (e.g. being considered for palliative care)
- Patients with active bleeding in the preceding 7 days
- Patients who in the opinion of the investigator are not suitable
- Exclusion Criteria (cohort 2):
- Females who are pregnant
- Known allergies to the IMP or excipients of IMP
- Fibrinogen \< 1.5 g/L at time of screening
- Patients considered inappropriate for active treatment (e.g. being considered for palliative care)
- Patients who in the opinion of the investigator are not suitable
Exclusion
Key Trial Info
Start Date :
April 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2021
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04356833
Start Date
April 22 2020
End Date
March 18 2021
Last Update
August 11 2025
Active Locations (1)
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1
The Royal Free Hospital
London, United Kingdom, NW3 2QG