Ignite Creation Date:
2024-05-06 @ 2:31 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04340557
Status:
COMPLETED
Last Update Posted:
2021-05-26
First Post:
2020-04-06
Brief Title:
Do Angiotensin Receptor Blockers Mitigate Progression to Acute Respiratory Distress Syndrome With SARS-CoV-2 Infection
Sponsor:
Sharp HealthCare
Organization:
Sharp HealthCare
Study Overview
Official Title:
Randomized Open Label Study of Standard of Care Plus an Angiotensin II Receptor Blocker Compared to Standard of Care Alone to Minimize the Progression to Respiratory Failure in SARS-CoV-2 Infection
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research is to identify whether or not Angiotensin Receptor Blockers ARB can halt the progression to respiratory failure requiring transfer into the intensive care unit ICU as well as halt mechanical ventilation in subjects with mild to moderate hypoxia due to the corona virus that causes COVID-19 Based on previous animal studies the researchers hypothesize that the addition of an ARB is beneficial in abating acute lung injury in subjects in early stages of SARS-CoV-2 viral induced hypoxia
Detailed Description:
This is an investigator initiated open label multicenter two arm randomized study to compare the impact of adding an ARB to the Standard of Care SOC to the SOC without an ARB Randomization ratio will be 11 The goal of this study is to identify whether or not ARBs have an impact on inhibiting the progression to respiratory failure requiring mechanical ventilation in patients with mild to moderate hypoxia in the setting of COVID-19 The addition of an ARB to the standard of care treatment for these patients may be beneficial in abating acute lung injury in patients in early stages of SARS-CoV-2 induced hypoxia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2003902 | OTHER | Sharp HealthCare Institutional Review Board SHC IRB | None |