Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04922957
Status:
TERMINATED
Last Update Posted:
2024-03-13
First Post:
2021-06-09
Brief Title:
A Phase 2b Multi-Center Randomized Double-Blind Placebo-Controlled Study Evaluating Efficacy and Safety of Allocetra-OTS in Patients With Severe or Critical COVID-19 With Associated Acute Respiratory Distress Syndrome ARDS
Sponsor:
Enlivex Therapeutics Ltd
Organization:
Enlivex Therapeutics Ltd
Study Overview
Official Title:
A Phase 2b Multi-Center Randomized Double-Blind Placebo-Controlled Study Evaluating Efficacy and Safety of Allocetra-OTS in Patients With Severe or Critical COVID-19 With Associated Acute Respiratory Distress Syndrome ARDS
Status:
TERMINATED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
strategic reprioritization
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 2b multi-center randomized double-blind placebo-controlled study evaluating the efficacy and safety of intravenous IV Allocetra-OTS 10x109 cells vs placebo 11 in adult hospitalized patients with severe or critical Coronavirus Disease 2019 COVID-19 with associated acute respiratory distress syndrome ARDS Patients will be followed for efficacy and safety for 6 months The trial will include periodic and ad-hoc DSMB review during the study period
Detailed Description:
This is a Phase 2b multi-center randomized double-blind placebo-controlled study evaluating the efficacy and safety of intravenous IV Allocetra-OTS 10x109 cells vs placebo 11 in adult hospitalized patients with severe or critical Coronavirus Disease 2019 COVID-19 with associated acute respiratory distress syndrome ARDS
Severe and critical COVID-19 are defined as follows
Severe COVID-19 shortness of breath at rest or respiratory distress or respiratory rate RR 30 per minute or SpO2 93 on room air at sea level
Critical COVID-19 respiratory failure requiring at least one of the following oxygen delivered by high-flow nasal cannula or noninvasive positive pressure ventilation
After a patient has signed the informed consent form ICF and after confirmation that the patient meets all eligibility criteria the patient will be enrolled in the study The two subpopulations severely ill and critically ill patients will be randomized 11 into the active treatment and placebo groups via two separate randomizations schemes
Study treatment Investigational Product or placebo administration will occur on Day 1 as close as possible to and no later than 48 hours from randomization Assessments performed on Day 1 prior to study treatment administration will be considered as baseline assessments
Patients will be followed for efficacy and safety through 6 months Following study treatment administration patients will be assessed daily for a period of 7 days The next visits are planned to occur on Days 14 28 and 60 A safety follow-up phone call will be scheduled to occur 6 months post study treatment Hospitalized patients will be monitored on a daily basis until discharge or up to 60 days post study treatment administration
Blood samples for safety assessment will be analyzed locally as per institutional guidelines
Additional blood samples will be collected for potential exploratory analyses Such biomarker analyses will be performed centrally as per Sponsor requirements
Patients who drop out within the interval between the randomization and study treatment administration will be replaced to keep the originally planned sample size
The trial will include periodic and ad-hoc Data Safety Monitoring Board DSMB review during the study period
Severe and critical COVID-19 are defined as follows
Severe COVID-19 shortness of breath at rest or respiratory distress or respiratory rate RR 30 per minute or SpO2 93 on room air at sea level
Critical COVID-19 respiratory failure requiring at least one of the following oxygen delivered by high-flow nasal cannula or noninvasive positive pressure ventilation
After a patient has signed the informed consent form ICF and after confirmation that the patient meets all eligibility criteria the patient will be enrolled in the study The two subpopulations severely ill and critically ill patients will be randomized 11 into the active treatment and placebo groups via two separate randomizations schemes
Study treatment Investigational Product or placebo administration will occur on Day 1 as close as possible to and no later than 48 hours from randomization Assessments performed on Day 1 prior to study treatment administration will be considered as baseline assessments
Patients will be followed for efficacy and safety through 6 months Following study treatment administration patients will be assessed daily for a period of 7 days The next visits are planned to occur on Days 14 28 and 60 A safety follow-up phone call will be scheduled to occur 6 months post study treatment Hospitalized patients will be monitored on a daily basis until discharge or up to 60 days post study treatment administration
Blood samples for safety assessment will be analyzed locally as per institutional guidelines
Additional blood samples will be collected for potential exploratory analyses Such biomarker analyses will be performed centrally as per Sponsor requirements
Patients who drop out within the interval between the randomization and study treatment administration will be replaced to keep the originally planned sample size
The trial will include periodic and ad-hoc Data Safety Monitoring Board DSMB review during the study period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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