Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04708236
Status:
WITHDRAWN
Last Update Posted:
2021-06-14
First Post:
2021-01-08
Brief Title:
A Study of ORTD-1 in Patients Hospitalized With COVID-19 Related Pneumonia
Sponsor:
Oryn Therapeutics LLC
Organization:
Oryn Therapeutics LLC
Study Overview
Official Title:
A Blinded Controlled Escalating Dose Study of ORTD-1 for Treatment of Hospitalized Patients With SARS-CoV-2 COVID-19 Related Pneumonia
Status:
WITHDRAWN
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluate the safety and effect of ORTD-1 on COVID-19 related pneumonia
Detailed Description:
This is a randomized blinded vehicle-controlled dose-escalation study Initial enrollment and treatment will be conducted as an inpatient study Patients will be randomized 21 ORTD-1 treatment versus vehicle control Patients will be allocated into 1 of 3 sequential escalating dose cohorts Blinded study drug will be infused intravenously once daily for 5 consecutive days
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?:
None
Is an FDA AA801 Violation?:
None