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

STATUS

Recruiting
End date

Feb 15, 2023
participants needed

320
sponsor

Boehringer Ingelheim

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Updated on 12 May 2022

See if I qualify

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	Acute Respiratory Distress Syndrome
Treatment	Standard of Care, Alteplase
Clinical Study Identifier	NCT04640194
Sponsor	Boehringer Ingelheim
Last Modified on	12 May 2022

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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 ≥ lower limit of normal (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
	D-Dimer ≥ upper limit of normal (ULN) according to local laboratory
Exclusion Criteria
	Massive confirmed pulmonary embolism (PE) with haemodynamic instability at trial entry, or any (suspected or confirmed) PE that is expected to require therapeutic dosages of anticoagulants during the treatment period
	Indication for therapeutic dosages of anticoagulants 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
	Planned interventions during the first 5 days after randomisation, such as surgery, insertion of central catheter or arterial line, drains, etc
	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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Step 2 Get screened

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Step 3 Enroll in the clinical study

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Step 4 Get your study results

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