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Tolerability and Efficacy of RJX in Patients With COVID-19 (RJX)

Primary Purpose

COVID-19, Acute Respiratory Distress Syndrome, SARS-CoV-2

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Rejuveinix (RJX) Active Comparator
Placebo Comparator
Sponsored by
Reven Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Cohort 1 (Part 1 and Part 2):

  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)
  2. Hospitalized COVID-19 patients age ≥65 years AND type 2 diabetes or hypertension, OR
  3. Hospitalized COVID-19 patients ≥18 years AND abnormal blood tests with CRP >50 mg/L PLUS at least 1 of the following biomarkers:

    1. D-dimer >1,000 ng/mL
    2. Ferritin >500 µg/L
    3. High sensitivity cardiac troponin >2 × ULN
    4. LDH >245 U/L

    Cohort 2 (Part 1 and Part 2):

  4. Hospitalized COVID-19 patients with hypoxemia who are either receiving NIPPV OR high-flow oxygen (namely, clinical status score 3 on an 8-point ordinal scale).
  5. Bilateral opacities on a chest x-ray OR chest CT scan. Cohort 1 and Cohort 2 (Parts 1 and 2)
  6. Male and non-pregnant, non-lactating female patients with SARS-CoV-2 infection that is documented by a Food and Drug Administration (FDA)-authorized diagnostic reverse transcription polymerase chain reaction test at/or within 4 days of Screening
  7. ≥18 years of age
  8. Body weight ≥40 kg at Screening
  9. History of COVID-19 within the last 2 weeks prior to study enrollment
  10. The patient OR a legally authorized representative has provided written informed consent
  11. Females of childbearing potential must have a negative beta human chorionic gonadotropin pregnancy test at Screening
  12. Females of childbearing potential must agree to be abstinent or else use a medically acceptable form of contraception from the Screening period through Day 28. Medically acceptable forms of contraception including implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomy, and double-barrier method [condom and occlusive cap (diaphragm or cervical/vault caps)] with spermicidal foam/gel/film/suppository

Exclusion Criteria Cohort 1

  1. Receiving high-flow oxygen OR NIPPV. Cohort 1 and Cohort 2
  2. ARDS by Berlin definition (Appendix 16.2)
  3. On extracorporeal membrane oxygenation
  4. Uncontrolled hypertension (systolic blood pressure [BP] >150 mmHg and/or diastolic BP >100 mmHg), unstable angina, congestive heart failure of New York Heart Association Classification Class III or IV (i.e., Class III: marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g., walking short distances [20 100 m], comfortable only at rest; Class IV: severe limitations, experiences symptoms even while at rest, mostly bedbound patients), serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 12 months prior to enrollment
  5. Subjects with a history of congenital long QT syndrome or of Torsades de pointes; subjects with bradycardia (<60 bpm), heart block (excluding 1st degree block, being PR interval prolongation only); subjects with any of the following findings on electrocardiogram (ECG): QTc interval >470 msec in women OR >450 msec in men; subjects requiring any drugs known to prolong the QTc interval, including antiarrhythmic medications
  6. Shock or hypotension requiring vasoactive peptides, such as dopamine, norepinephrine, epinephrine, or dobutamine
  7. Renal function impairment with creatinine ≥2 mg/dL
  8. Liver function impairment with total bilirubin ≥2 mg/dL
  9. Platelet count <50,000/µL
  10. Multi-organ failure
  11. History of an allergic reaction or hypersensitivity to the study drug or any component of the study drug formulation
  12. Use of systemic corticosteroids, nonsteroidal anti-inflammatory drugs, antibiotics, and antiviral drugs that are not part of the standard of care
  13. Presence of any uncontrolled concomitant illness (e.g., bacterial sepsis or invasive fungal infection), or other serious illness and medical conditions, or other medical history, including laboratory results, which, in the Investigator's opinion, would be likely to interfere with their participation in the study
  14. Pregnancy or breast-feeding (for women)

Sites / Locations

  • Memorial Hermann Memorial City Medical Center
  • Memorial Hermann Southeast Hospital
  • Christus Santa Rosa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm A: RJX

Arm B: Placebo

Arm Description

RJX 20 mL (10 mL of Vial A plus 10 mL of Vial B) mixed in normal saline, total volume 120 mL, administered by IV infusion over a period of 40 minutes +/- 10 minutes once daily. Standard of care (current antiviral and/or supportive care treatment currently in place at the institution for COVID-19 treatment). Patients in Part 1 are allowed to receive only one 7-day cycle of RJX while patients in Part 2 may be treated daily for up to 14 days.

Placebo (total of 20 mL normal saline) mixed in normal saline IV, total volume 120 mL of normal saline IV, administered by IV infusion over a period of 40 minutes +/- 10 minutes once daily. Standard of care (current antiviral and/or supportive care treatment currently in place at the institution for COVID-19 treatment). Patients in Part 1 will not receive placebo. Patients in Part 2 may be treated daily for up to 14 days.

Outcomes

Primary Outcome Measures

Safety as measured by DLTs and drug related SAE's
• Part 1, Cohorts 1 and 2: Cumulative incidence of DLTs and drug-related SAEs (viz., sum of DLT + SAEs) reported within 14 days of first dose of RJX (Part 1) or reported within 60 days of first dose of study drug (Part 2)
Tolerability and Efficacy measured by progression of disease through an ordinal scale.
• Part 2, Cohort 1: Progression to severe disease on an 8-point ordinal scale from a clinical status score of 4 or 5 to a clinical status score of 3, 2, or 1 within 2 weeks of first dose of study drug
Efficacy measured by time to resolution of respiratory failure
• Part 2, Cohort 2: Time to resolution of respiratory failure (TTRRF), with status change on an 8-point ordinal scale from a clinical status score of 3 to a clinical status score of ≥4

Secondary Outcome Measures

Efficacy as measured by day of ICU care.
The key secondary endpoints for Parts 1 and 2, Cohorts 1 and 2 are: • Mean number of days of ICU care
Safety, Tolerability, Efficacy measured by mortality over 28 Days.
The key secondary endpoints for Parts 1 and 2, Cohorts 1 and 2 are: • Proportion of patients that die (any cause) by Day 28 post randomization (patient may be inpatient or outpatient in follow up)
Efficacy measured by mean change in baseline clinical status on Days 7 and 14.
Additional secondary endpoint for Parts 1 and 2, Cohorts 1 and 2 are: • Mean change from baseline of clinical status using an 8-point ordinal scale (with 8 being "Not hospitalized, no limitations on activities", and 1 being "Death") at Days 7 and 14
Efficacy measured by mean change in hospitalization days on Days 7 and 14.
Additional secondary endpoint for Parts 1 and 2, Cohorts 1 and 2 are: • Mean number of hospitalization days
Efficacy measured by time to coming off supplemental oxygen on Days 7 and 14.
Additional secondary endpoint for Parts 1 and 2, Cohorts 1 and 2 are: • Time to coming off supplemental oxygen (defined as a score of ≥5 on an 8-point ordinal scale; Cohort 1 only)
Safety and Efficacy measured by time from first dose to renal therapy.
Additional secondary endpoint for Cohort 2, Part 2 is: • Time to initiation of renal replacement therapy

Full Information

First Posted
January 4, 2021
Last Updated
March 14, 2022
Sponsor
Reven Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04708340
Brief Title
Tolerability and Efficacy of RJX in Patients With COVID-19
Acronym
RJX
Official Title
A Two-part, Two-cohort, Double-blind, Randomized, Placebo-controlled, Multicenter Phase 1/2 Study to Evaluate the Safety, Tolerability and Efficacy of REJUVEINIX (RJX) in Patients With COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 25, 2021 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reven Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is designed as a 2-part, 2-cohort, double-blind, randomized, placebo controlled, multicenter Phase 1/2 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 14/Discharge, 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 Age ≥65 years AND type 2 diabetes or hypertension OR Age ≥18 years with abnormal blood tests AND CRP >50 mg/L PLUS at least 1 of the following biomarkers: D-dimer >1,000 ng/mL, Ferritin >500 µg/L, High sensitivity cardiac troponin >2 × upper limit of normal (ULN), LDH >245 U/L. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Acute Respiratory Distress Syndrome, SARS-CoV-2, Hypoxemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
In Part 1, RJX will be administered daily for 7 days (1 cycle). In Part 2, Placebo or RJX will be administered daily for 7 days for 1 cycle but may receive 2 cycles. Each Cohort is comprised of Part 1, a single site, and Part 2, multiple sites. The 2 Cohorts are: Cohort 1: Hospitalized COVID-19 patients ≥18 years without hypoxemia and either not receiving any oxygen therapy OR are receiving supplemental oxygen via mask or nasal prongs (clinical status score 4 or 5 on 8-point ordinal scale). Patients are required to have the following high-risk characteristics Age ≥65 years AND type 2 diabetes or hypertension OR Age ≥18 years with abnormal blood tests AND CRP >50 mg/L PLUS at least 1 of the following biomarkers abnormal: a. D-dimer, b. Ferritin, c. High sensitivity cardiac troponin, d. LDH Cohort 2: • Hospitalized COVID-19 patients with hypoxemia and without ARDS who are receiving either non-invasive positive pressure ventilation (NIPPV) OR high flow oxygen
Masking
ParticipantInvestigator
Masking Description
Masking the dose administered
Allocation
Randomized
Enrollment
237 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: RJX
Arm Type
Active Comparator
Arm Description
RJX 20 mL (10 mL of Vial A plus 10 mL of Vial B) mixed in normal saline, total volume 120 mL, administered by IV infusion over a period of 40 minutes +/- 10 minutes once daily. Standard of care (current antiviral and/or supportive care treatment currently in place at the institution for COVID-19 treatment). Patients in Part 1 are allowed to receive only one 7-day cycle of RJX while patients in Part 2 may be treated daily for up to 14 days.
Arm Title
Arm B: Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (total of 20 mL normal saline) mixed in normal saline IV, total volume 120 mL of normal saline IV, administered by IV infusion over a period of 40 minutes +/- 10 minutes once daily. Standard of care (current antiviral and/or supportive care treatment currently in place at the institution for COVID-19 treatment). Patients in Part 1 will not receive placebo. Patients in Part 2 may be treated daily for up to 14 days.
Intervention Type
Drug
Intervention Name(s)
Rejuveinix (RJX) Active Comparator
Other Intervention Name(s)
RJX, Rejuveinix
Intervention Description
Active drug comprised of: ascorbic acid, magnesium sulfate heptahydrate, cyanocobalamin, thiamine, riboflavin 5' phosphate, niacinamide, pyridoxine, calcium d-pantothenate, and sodium bicarbonate.
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Other Intervention Name(s)
0.9% Sodium Chloride in Water for Injection, USP., Normal Saline for Injection, USP
Intervention Description
0.9% Sodium Chloride in Water for Injection a.k.a. Normal Saline for injection
Primary Outcome Measure Information:
Title
Safety as measured by DLTs and drug related SAE's
Description
• Part 1, Cohorts 1 and 2: Cumulative incidence of DLTs and drug-related SAEs (viz., sum of DLT + SAEs) reported within 14 days of first dose of RJX (Part 1) or reported within 60 days of first dose of study drug (Part 2)
Time Frame
Up to 60 days post-enrollment
Title
Tolerability and Efficacy measured by progression of disease through an ordinal scale.
Description
• Part 2, Cohort 1: Progression to severe disease on an 8-point ordinal scale from a clinical status score of 4 or 5 to a clinical status score of 3, 2, or 1 within 2 weeks of first dose of study drug
Time Frame
Within 2 weeks
Title
Efficacy measured by time to resolution of respiratory failure
Description
• Part 2, Cohort 2: Time to resolution of respiratory failure (TTRRF), with status change on an 8-point ordinal scale from a clinical status score of 3 to a clinical status score of ≥4
Time Frame
60-days post enrollment
Secondary Outcome Measure Information:
Title
Efficacy as measured by day of ICU care.
Description
The key secondary endpoints for Parts 1 and 2, Cohorts 1 and 2 are: • Mean number of days of ICU care
Time Frame
60-days post enrollment
Title
Safety, Tolerability, Efficacy measured by mortality over 28 Days.
Description
The key secondary endpoints for Parts 1 and 2, Cohorts 1 and 2 are: • Proportion of patients that die (any cause) by Day 28 post randomization (patient may be inpatient or outpatient in follow up)
Time Frame
28-days post enrollment
Title
Efficacy measured by mean change in baseline clinical status on Days 7 and 14.
Description
Additional secondary endpoint for Parts 1 and 2, Cohorts 1 and 2 are: • Mean change from baseline of clinical status using an 8-point ordinal scale (with 8 being "Not hospitalized, no limitations on activities", and 1 being "Death") at Days 7 and 14
Time Frame
14-days post enrollment
Title
Efficacy measured by mean change in hospitalization days on Days 7 and 14.
Description
Additional secondary endpoint for Parts 1 and 2, Cohorts 1 and 2 are: • Mean number of hospitalization days
Time Frame
14-days post enrollment
Title
Efficacy measured by time to coming off supplemental oxygen on Days 7 and 14.
Description
Additional secondary endpoint for Parts 1 and 2, Cohorts 1 and 2 are: • Time to coming off supplemental oxygen (defined as a score of ≥5 on an 8-point ordinal scale; Cohort 1 only)
Time Frame
14-days post enrollment
Title
Safety and Efficacy measured by time from first dose to renal therapy.
Description
Additional secondary endpoint for Cohort 2, Part 2 is: • Time to initiation of renal replacement therapy
Time Frame
60-days post enrollment
Other Pre-specified Outcome Measures:
Title
Evaluate Change in Serum CRP Concentration
Description
The exploratory endpoint for Parts 1 and 2 is: Kinetic of response of CRP (comparison of baseline to Day 7, Day 14, and Day 28 post-randomization). These laboratory measures will be obtained either as an inpatient or an outpatient follow-up.
Time Frame
Up to 28-days post randomization
Title
Evaluate Change in Serum Ferritin Concentration
Description
The exploratory endpoint for Parts 1 and 2 is: Kinetic of response of ferritin (comparison of baseline to Day 7, Day 14, and Day 28 post-randomization). These laboratory measures will be obtained either as an inpatient or an outpatient follow-up.
Time Frame
Up to 28-days post randomization
Title
Evaluate Change in Serum D-dimer Concentration
Description
The exploratory endpoint for Parts 1 and 2 is: Kinetic of response of D-dimer (comparison of baseline to Day 7, Day 14, and Day 28 post-randomization). These laboratory measures will be obtained either as an inpatient or an outpatient follow-up.
Time Frame
Up to 28-days post randomization
Title
Evaluate Change in Serum LDH Concentration
Description
The exploratory endpoint for Parts 1 and 2 is: Kinetic of response of LDH (comparison of baseline to Day 7, Day 14, and Day 28 post-randomization). These laboratory measures will be obtained either as an inpatient or an outpatient follow-up.
Time Frame
Up to 28-days post randomization
Title
Evaluate Change in Serum IL-6 Concentration
Description
The exploratory endpoint for Parts 1 and 2 is: Kinetic of response of IL-6 (comparison of baseline to Day 7, Day 14, and Day 28 post-randomization). These laboratory measures will be obtained either as an inpatient or an outpatient follow-up.
Time Frame
Up to 28-days post randomization
Title
Evaluate Change in Serum IL-10 Concentration
Description
The exploratory endpoint for Parts 1 and 2 is: Kinetic of response of IL-10 (comparison of baseline to Day 7, Day 14, and Day 28 post-randomization). These laboratory measures will be obtained either as an inpatient or an outpatient follow-up.
Time Frame
Up to 28-days post randomization
Title
Evaluate Change in Serum TNF-α Concentration
Description
The exploratory endpoint for Parts 1 and 2 is: Kinetic of response of TNF-α (comparison of baseline to Day 7, Day 14, and Day 28 post-randomization). These laboratory measures will be obtained either as an inpatient or an outpatient follow-up.
Time Frame
Up to 28-days post randomization
Title
Evaluate Change in Serum TGF-β Concentration
Description
The exploratory endpoint for Parts 1 and 2 is: Kinetic of response of TGF-β (comparison of baseline to Day 7, Day 14, and Day 28 post-randomization). These laboratory measures will be obtained either as an inpatient or an outpatient follow-up.
Time Frame
Up to 28-days post randomization
Title
Evaluate Change in Serum C3 Concentration
Description
The exploratory endpoint for Parts 1 and 2 is: Kinetic of response of C3 (comparison of baseline to Day 7, Day 14, and Day 28 post-randomization). These laboratory measures will be obtained either as an inpatient or an outpatient follow-up.
Time Frame
Up to 28-days post randomization
Title
Evaluate Change in Serum C5 Concentration
Description
The exploratory endpoint for Parts 1 and 2 is: Kinetic of response of C5 (comparison of baseline to Day 7, Day 14, and Day 28 post-randomization). These laboratory measures will be obtained either as an inpatient or an outpatient follow-up.
Time Frame
Up to 28-days post randomization
Title
Evaluate Change in Plasma ascorbic acid Concentration
Description
The exploratory endpoint for Parts 1 and 2 is: Kinetic of response of ascorbic acid (comparison of baseline to Day 7, Day 14, and Day 28 post-randomization). These laboratory measures will be obtained either as an inpatient or an outpatient follow-up.
Time Frame
Up to 28-days post randomization
Title
Evaluate Change in plasma niacinamide Concentration
Description
The exploratory endpoint for Parts 1 and 2 is: Kinetic of response of niacinamide (comparison of baseline to Day 7, Day 14, and Day 28 post-randomization). These laboratory measures will be obtained either as an inpatient or an outpatient follow-up.
Time Frame
Up to 28-days post randomization
Title
Evaluate Change in plasma thiamine Concentration
Description
The exploratory endpoint for Parts 1 and 2 is: Kinetic of response of thiamine (comparison of baseline to Day 7, Day 14, and Day 28 post-randomization). These laboratory measures will be obtained either as an inpatient or an outpatient follow-up.
Time Frame
Up to 28-days post randomization
Title
Evaluate Change in plasma cyanocobalamin Concentration
Description
The exploratory endpoint for Parts 1 and 2 is: Kinetic of response of cyanocobalamin (comparison of baseline to Day 7, Day 14, and Day 28 post-randomization). These laboratory measures will be obtained either as an inpatient or an outpatient follow-up.
Time Frame
Up to 28-days post randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Cohort 1 (Part 1 and Part 2): 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) Hospitalized COVID-19 patients age ≥65 years AND type 2 diabetes or hypertension, OR Hospitalized COVID-19 patients ≥18 years AND abnormal blood tests with CRP >50 mg/L PLUS at least 1 of the following biomarkers: D-dimer >1,000 ng/mL Ferritin >500 µg/L High sensitivity cardiac troponin >2 × ULN LDH >245 U/L Cohort 2 (Part 1 and Part 2): Hospitalized COVID-19 patients with hypoxemia who are either receiving NIPPV OR high-flow oxygen (namely, clinical status score 3 on an 8-point ordinal scale). Bilateral opacities on a chest x-ray OR chest CT scan. Cohort 1 and Cohort 2 (Parts 1 and 2) Male and non-pregnant, non-lactating female patients with SARS-CoV-2 infection that is documented by a Food and Drug Administration (FDA)-authorized diagnostic reverse transcription polymerase chain reaction test at/or within 4 days of Screening ≥18 years of age Body weight ≥40 kg at Screening History of COVID-19 within the last 2 weeks prior to study enrollment The patient OR a legally authorized representative has provided written informed consent Females of childbearing potential must have a negative beta human chorionic gonadotropin pregnancy test at Screening Females of childbearing potential must agree to be abstinent or else use a medically acceptable form of contraception from the Screening period through Day 28. Medically acceptable forms of contraception including implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomy, and double-barrier method [condom and occlusive cap (diaphragm or cervical/vault caps)] with spermicidal foam/gel/film/suppository Exclusion Criteria Cohort 1 Receiving high-flow oxygen OR NIPPV. Cohort 1 and Cohort 2 ARDS by Berlin definition (Appendix 16.2) On extracorporeal membrane oxygenation Uncontrolled hypertension (systolic blood pressure [BP] >150 mmHg and/or diastolic BP >100 mmHg), unstable angina, congestive heart failure of New York Heart Association Classification Class III or IV (i.e., Class III: marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g., walking short distances [20 100 m], comfortable only at rest; Class IV: severe limitations, experiences symptoms even while at rest, mostly bedbound patients), serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 12 months prior to enrollment Subjects with a history of congenital long QT syndrome or of Torsades de pointes; subjects with bradycardia (<60 bpm), heart block (excluding 1st degree block, being PR interval prolongation only); subjects with any of the following findings on electrocardiogram (ECG): QTc interval >470 msec in women OR >450 msec in men; subjects requiring any drugs known to prolong the QTc interval, including antiarrhythmic medications Shock or hypotension requiring vasoactive peptides, such as dopamine, norepinephrine, epinephrine, or dobutamine Renal function impairment with creatinine ≥2 mg/dL Liver function impairment with total bilirubin ≥2 mg/dL Platelet count <50,000/µL Multi-organ failure History of an allergic reaction or hypersensitivity to the study drug or any component of the study drug formulation Use of systemic corticosteroids, nonsteroidal anti-inflammatory drugs, antibiotics, and antiviral drugs that are not part of the standard of care Presence of any uncontrolled concomitant illness (e.g., bacterial sepsis or invasive fungal infection), or other serious illness and medical conditions, or other medical history, including laboratory results, which, in the Investigator's opinion, would be likely to interfere with their participation in the study Pregnancy or breast-feeding (for women)
Facility Information:
Facility Name
Memorial Hermann Memorial City Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Memorial Hermann Southeast Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Christus Santa Rosa Hospital
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Tolerability and Efficacy of RJX in Patients With COVID-19

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