Tolerability and Efficacy of RJX in Patients With COVID-19

Status unconfirmed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: COVID-19, Acute Respiratory Distress Syndrome, SARS-CoV-2, Hypoxemia

In brief

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.

Key facts

Study ID

NCT04708340

Run by

Reven Pharmaceuticals, Inc.

People needed

237

Starts

2021-03-25

Expected to finish

2023-02-01

Last updated by the study team

2022-03-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Memorial Hermann Memorial City Medical Center — Houston, Texas, United States
• Memorial Hermann Southeast Hospital — Houston, Texas, United States
• Christus Santa Rosa Hospital — New Braunfels, Texas, United States

Full record on ClinicalTrials.gov

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