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Clinical Trials/EUCTR2020-001640-26-GB
EUCTR2020-001640-26-GB
Active, not recruiting
Phase 1

A pilot, open label, phase II clinical trial of nebulised recombinant tissue-Plasminogen Activator (rtPA)in patients with COVID-19 ARDS: The Plasminogen Activator COVID-19 ARDS (PACA) trial - Nebulised rtPA for ARDS due to COVID-19 – The PACA trial

niversity College London0 sites36 target enrollmentApril 9, 2020
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ConditionsAcute respiratory distress syndrome (ARDS) caused by COVID-19Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
DrugsActilyse

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Acute respiratory distress syndrome (ARDS) caused by COVID-19
Sponsor
niversity College London
Enrollment
36
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 9, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity College London

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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