Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04708340
Status:
UNKNOWN
Last Update Posted:
2022-03-15
First Post:
2021-01-04
Brief Title:
Tolerability and Efficacy of RJX in Patients With COVID-19
Sponsor:
Reven Pharmaceuticals Inc
Organization:
Reven Pharmaceuticals Inc
Study Overview
Official Title:
A Two-part Two-cohort Double-blind Randomized Placebo-controlled Multicenter Phase 12 Study to Evaluate the Safety Tolerability and Efficacy of REJUVEINIX RJX in Patients With COVID-19
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
RJX
Brief Summary:
This study is designed as a 2-part 2-cohort double-blind randomized placebo controlled multicenter Phase 12 study to evaluate the safety tolerability and efficacy of RJX in patients with COVID-19
Detailed Description:
For each cohort there will be an open label Safety Lead-in Part 1 and a placebo controlled randomized double-blind portion Part 2 In Part 1 RJX will be administered daily for 7 days In the active treatment arm of Part 2 for both cohorts RJX will be administered daily for 7 days per cycle and patients may receive up to 2 cycles As detailed below patients will be allowed to receive a second 7 day cycle of therapy based on the medical judgment of the Investigator The total RJX exposure during Part 2 could therefore be up to 14 days Both cohorts will start and enroll in parallel and independently A safety follow-up period will begin at Day 14Discharge or when treatment is discontinued and will continue for approximately 60 days post discharge Part 1 will be conducted at a single site and Part 2 will be conducted at multiple sites The 2 cohorts in this study are
Cohort 1
Hospitalized COVID-19 patients 18 years without hypoxemia who are either not receiving any oxygen therapy OR are receiving supplemental oxygen via mask or nasal prongs namely clinical status score 4 or 5 on an 8-point ordinal scale
Patients are required to have the following high-risk characteristics
1 Age 65 years AND type 2 diabetes or hypertension OR
2 Age 18 years with abnormal blood tests AND CRP 50 mgL PLUS at least 1 of the following biomarkers
1 D-dimer 1000 ngmL
2 Ferritin 500 µgL
3 High sensitivity cardiac troponin 2 upper limit of normal ULN
4 LDH 245 UL
Cohort 2
Hospitalized COVID-19 patients with hypoxemia without ARDS who are receiving either non-invasive positive pressure ventilation NIPPV OR high flow oxygen namely clinical status score 3 on an 8-point ordinal scale
Cohort 1
Hospitalized COVID-19 patients 18 years without hypoxemia who are either not receiving any oxygen therapy OR are receiving supplemental oxygen via mask or nasal prongs namely clinical status score 4 or 5 on an 8-point ordinal scale
Patients are required to have the following high-risk characteristics
1 Age 65 years AND type 2 diabetes or hypertension OR
2 Age 18 years with abnormal blood tests AND CRP 50 mgL PLUS at least 1 of the following biomarkers
1 D-dimer 1000 ngmL
2 Ferritin 500 µgL
3 High sensitivity cardiac troponin 2 upper limit of normal ULN
4 LDH 245 UL
Cohort 2
Hospitalized COVID-19 patients with hypoxemia without ARDS who are receiving either non-invasive positive pressure ventilation NIPPV OR high flow oxygen namely clinical status score 3 on an 8-point ordinal scale
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