A Study to Test Whether Different Doses of Alteplase Help People With Severe Breathing Problems Because of COVID-19 : The TRISTARDS Trial - ThRombolysIS Therapy for ARDS A Phase IIb/III Operationally Seamless, Open-label, Randomised, Sequential, Parallel-group Adaptive Study to Evaluate the Efficacy and Safety of Daily Intravenous Alteplase Treatment Given up to 5 Days on Top of Standard of Care (SOC) Compared With SOC Alone, in Patients With Acute Respiratory Distress Syndrome (ARDS) Triggered by COVID-19
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..
Medienart: |
Klinische Studie |
---|
Erscheinungsjahr: |
2024 |
---|---|
Erschienen: |
2024 |
Enthalten in: |
ClinicalTrials.gov - (2024) vom: 20. März Zur Gesamtaufnahme - year:2024 |
---|
Sprache: |
Englisch |
---|
Links: |
Volltext [kostenfrei] |
---|
Themen: |
610 |
---|
Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: November 23, 2020, Last downloaded: ClinicalTrials.gov processed this data on March 27, 2024, Last updated: March 27, 2024 |
---|
Study ID: |
NCT04640194 |
---|---|
Veröffentlichungen zur Studie: |
|
fisyears: |
|
---|---|
Förderinstitution / Projekttitel: |
|
PPN (Katalog-ID): |
CTG000010715 |
---|
LEADER | 01000caa a22002652 4500 | ||
---|---|---|---|
001 | CTG000010715 | ||
003 | DE-627 | ||
005 | 20240327010452.0 | ||
007 | cr uuu---uuuuu | ||
008 | 240313s2024 xx |||||o 00| ||eng c | ||
035 | |a (DE-627)CTG000010715 | ||
035 | |a (UBBS_Klinische_Studien)NCT04640194 | ||
035 | |a (UBBS_Klinische_Studien)0135-0347 | ||
035 | |a (UBBS_Klinische_Studien)2020-002913-16 | ||
040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
041 | |a eng | ||
245 | 1 | 0 | |a A Study to Test Whether Different Doses of Alteplase Help People With Severe Breathing Problems Because of COVID-19 |b The TRISTARDS Trial - ThRombolysIS Therapy for ARDS A Phase IIb/III Operationally Seamless, Open-label, Randomised, Sequential, Parallel-group Adaptive Study to Evaluate the Efficacy and Safety of Daily Intravenous Alteplase Treatment Given up to 5 Days on Top of Standard of Care (SOC) Compared With SOC Alone, in Patients With Acute Respiratory Distress Syndrome (ARDS) Triggered by COVID-19 |
264 | 1 | |c 2024 | |
336 | |a Text |b txt |2 rdacontent | ||
337 | |a Computermedien |b c |2 rdamedia | ||
338 | |a Online-Ressource |b cr |2 rdacarrier | ||
500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: November 23, 2020, Last downloaded: ClinicalTrials.gov processed this data on March 27, 2024, Last updated: March 27, 2024 | ||
520 | |a 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. | ||
650 | 2 | |a Respiratory Distress Syndrome | |
650 | 2 | |a Respiratory Distress Syndrome, Newborn | |
650 | 2 | |a Acute Lung Injury | |
650 | 2 | |a Syndrome | |
650 | 4 | |a Study Type: Interventional | |
650 | 4 | |a Recruitment Status: Completed | |
650 | 4 | |a Phase: Phase 2, Phase 3 | |
650 | 4 | |a 610 | |
773 | 0 | 8 | |i Enthalten in |t ClinicalTrials.gov |g (2024) vom: 20. März |
773 | 1 | 8 | |g year:2024 |g day:20 |g month:03 |
856 | 4 | 0 | |u https://clinicaltrials.gov/show/NCT04640194 |z kostenfrei |3 Volltext |
912 | |a GBV_CTG | ||
951 | |a AR | ||
952 | |j 2024 |b 20 |c 03 |