A clinical trial of nebulised recombinant tissue plasminogen activator (rtPA) in patients with COVID-19 Acute Respiratory Distress Syndrome to decrease the duration of ventilatory support and mortality: A pilot study (the PACA trial)

Phase 1

• Conditions: Acute respiratory distress syndrome (ARDS) caused by COVID-19; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001640-26-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-09
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

All treatment group patients must meet the following criteria (ward or ICU based):
1.Patients with COVID-19 (confirmed by PCR or radiologically)
2.=16 years
3.Willing and able to provide written informed consent or where patient doesn’t have capacity, consent obtained from a legal representative
4.Patients on IMV must meet both the following criteria:
a.PaO2/FiO2 of = 300
b.Intubated > 6 hrs
5.Patients not intubated must meet all the following criteria:
a.PaO2/FiO2 = 300 or equivalent imputed by non-linear calculation from SpO2/FiO2 (see look-up table in appendices)
b.In-patient >6hours and being actively treated
c.On support with non-invasive ventilation OR continuous positive airway pressure (CPAP) OR high flow OR standard oxygen therapy

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 7
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

None of the following criteria must apply:
1.Females who are pregnant
2.Concurrent involvement in another experimental investigational medicinal product
3.Known allergies to the IMP or excipients of IMP
4.A pre-existing bleeding disorder with no definitive treatment (e.g. severe haemophilia)
5.Pre-existing severe cardiopulmonary disease (e.g. incurable lung cancer, severe chronic obstructive lung disease, cardiomyopathy, heart failure or impaired contractility 6.Fibrinogen < 2.0 g/L at time of screening
7.Patients considered inappropriate for active treatment (e.g. being considered for palliative care)
8.Patients with active bleeding in the preceding 7 days
9.Patients who in the opinion of the investigator are not suitable

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified