A Study to Test Whether Different Doses of Alteplase Help People With Severe Breathing Problems Because of COVID-19

  • STATUS
    Recruiting
  • End date
    Jul 15, 2022
  • participants needed
    270
  • sponsor
    Boehringer Ingelheim
Updated on 17 September 2021
ct scan
mechanical ventilation
chest x-ray
intubation
fluid overload
x-rays
d-dimer
acute respiratory distress
FIO2
respiratory failure
pao2
covid-19
pao2/fio2 ratio
SARS
oximetry
effusions
assisted breathing
assisted ventilation

Summary

This is a study in adults with severe breathing problems because of COVID-19. People who are in hospital on breathing support can participate in the study. The purpose of the study is to find out whether a medicine called alteplase helps people get better faster.

The study has 2 parts. In the first part, participants are put into 3 groups by chance. Participants in 2 of the groups get 2 different doses of alteplase, in addition to standard treatment.

Participants in the third group get standard treatment. In the second part of the study, participants are put into 2 groups by chance. One group gets alteplase and standard treatment. The other group gets only standard treatment. Alteplase is given as an infusion into a vein. In both study parts, treatments are given for 5 days. Doctors monitor patients and check whether their breathing problems improve. They compare results between the groups after 1 month.

Participants are in the study for 3 months.

Details
Condition Pulmonary Disease, ADULT RESPIRATORY DISTRESS SYNDROME, Acute Respiratory Distress Syndrome (ARDS), Acute Respiratory Distress, Lung Disease, acute respiratory distress syndrome, ards
Treatment Standard of Care, Alteplase
Clinical Study IdentifierNCT04640194
SponsorBoehringer Ingelheim
Last Modified on17 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years (or above legal age, e.g. UK 16 years)
ARDS with PaO2/FiO2 ratio >100 and 300, either on non-invasive ventilator support, OR on mechanical ventilation (<48 hours since intubation)
with bilateral opacities in chest X-ray or CT scan (not fully explained by effusions, lobar/lung collapse, or nodules)
with respiratory failure (not fully explained by cardiac failure/fluid overload) (or estimation of PaO2/FiO2 from pulse oximetry (SpO2/FiO2))
SARS-CoV-2 positive (laboratory-confirmed reverse transcription polymerase chain reaction (RT PCR) test)
Fibrinogen level upper limit of normal (according to local laboratory)
D-Dimer 3-fold of upper limit of normal (ULN) according to local laboratory
Signed and dated written informed consent in accordance with ICH Good Clinical Practice (GCP) and local legislation prior to admission to the Trial

Exclusion Criteria

Massive confirmed pulmonary embolism (PE) with haemodynamic instability at trial entry
Patients on mechanical ventilation for longer than 48 hours
Chronic pulmonary disease i.e. with known forced expiratory volume in 1 second (FEV1) <50%, requiring home oxygen, or oral steroid therapy or hospitalisation for exacerbation within 12 months, or significant chronic pulmonary disease in the Investigator's opinion, or primary pulmonary arterial hypertension
Has a Do-Not-Intubate (DNI) or Do-Not-Resuscitate (DNR) order
In the opinion of the investigator not expected to survive for > 48 hours after admission
Patients with known hypersensitivity to the active substance alteplase, gentamicin (a trace residue from the manufacturing process) or to any of the excipients
Significant bleeding disorder at present or within the past 3 months, known haemorrhagic diathesis
Patients receiving effective oral anticoagulant treatment, e.g. vitamin K antagonists with International normalised ratio (INR) >1.3, or any direct oral anticoagulant within the past 48 hours Further exclusion criteria apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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