Tazemetostat for the Treatment of Moderate to Severe COVID-19 Infection : Repurposing Tazemetostat for the Treatment of Acute Respiratory Distress Syndrome (ARDS) or Systemic Cytokine Release Syndrome (SCRS) in COVID-19 Patient
The investigators hypothesize that tazemetostat will mitigate the hyperinflammatory effects of COVID-19 infection, prevent respiratory deterioration, and reduce requirements of invasive ventilation. This will be conducted as a Phase II open label study. After being informed about the study and potential risks, all patients giving written informed consent will undergo randomization to receive 800 mg tazemetostat BID for 15 days in addition to standard of care treatment. The duration of the interventional part of the study will last 15 days, additionally the patients will be evaluated at 30 and 90 days for overall clinical status and sequelae. The study will be conducted at a single site (Loma Linda University Medical Center)..
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Klinische Studie| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
ClinicalTrials.gov - (2021) vom: 22. Nov. Zur Gesamtaufnahme - year:2021 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: August 24, 2021, Last downloaded: ClinicalTrials.gov processed this data on November 29, 2021, Last updated: December 01, 2021 |
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| Study ID: |
NCT05018975 |
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| Veröffentlichungen zur Studie: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
CTG007820321 |
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| 245 | 1 | 0 | |a Tazemetostat for the Treatment of Moderate to Severe COVID-19 Infection |b Repurposing Tazemetostat for the Treatment of Acute Respiratory Distress Syndrome (ARDS) or Systemic Cytokine Release Syndrome (SCRS) in COVID-19 Patient |
| 264 | 1 | |c 2021 | |
| 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: August 24, 2021, Last downloaded: ClinicalTrials.gov processed this data on November 29, 2021, Last updated: December 01, 2021 | ||
| 520 | |a The investigators hypothesize that tazemetostat will mitigate the hyperinflammatory effects of COVID-19 infection, prevent respiratory deterioration, and reduce requirements of invasive ventilation. This will be conducted as a Phase II open label study. After being informed about the study and potential risks, all patients giving written informed consent will undergo randomization to receive 800 mg tazemetostat BID for 15 days in addition to standard of care treatment. The duration of the interventional part of the study will last 15 days, additionally the patients will be evaluated at 30 and 90 days for overall clinical status and sequelae. The study will be conducted at a single site (Loma Linda University Medical Center). | ||
| 650 | 2 | |a COVID-19 | |
| 650 | 2 | |a Respiratory Distress Syndrome | |
| 650 | 2 | |a Respiratory Distress Syndrome, Newborn | |
| 650 | 2 | |a Acute Lung Injury | |
| 650 | 2 | |a Syndrome | |
| 650 | 2 | |a Cytokine Release Syndrome | |
| 650 | 4 | |a Medical Condition: COVID-19 Acute Respiratory Distress Syndrome, Cytokine Release Syndrome | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Withdrawn | |
| 650 | 4 | |a Phase: Phase 2 | |
| 650 | 4 | |a 610 | |
| 773 | 0 | 8 | |i Enthalten in |t ClinicalTrials.gov |g (2021) vom: 22. Nov. |
| 773 | 1 | 8 | |g year:2021 |g day:22 |g month:11 |
| 856 | 4 | 0 | |u https://clinicaltrials.gov/show/NCT05018975 |z kostenfrei |3 Volltext |
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