Status:
UNKNOWN
Tolerability and Efficacy of RJX in Patients With COVID-19
Lead Sponsor:
Reven Pharmaceuticals, Inc.
Conditions:
COVID-19
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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-...
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 a...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
March 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2023
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT04708340
Start Date
March 25 2021
End Date
February 1 2023
Last Update
March 15 2022
Active Locations (3)
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1
Memorial Hermann Memorial City Medical Center
Houston, Texas, United States, 77024
2
Memorial Hermann Southeast Hospital
Houston, Texas, United States, 77089
3
Christus Santa Rosa Hospital
New Braunfels, Texas, United States, 78130