COVID-19Phase 1/2RJXNCT04708340
Tolerability and Efficacy of RJX in Patients With COVID-19
A Phase 1/2 study testing Rejuveinix (RJX) Active Comparator in people with COVID-19 and Acute Respiratory Distress Syndrome, run by Reven Pharmaceuticals, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Acute Respiratory Distress Syndrome, SARS-CoV-2
- What is being tested?
- Rejuveinix (RJX) Active Comparator
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 237 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Mar 2021to Feb 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Memorial Hermann Memorial City Medical Center
Houston, Texas, 77024
Memorial Hermann Southeast Hospital
Houston, Texas, 77089
Christus Santa Rosa Hospital
New Braunfels, Texas, 78130
About this study
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
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.
Read the 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).
- Conditions
- COVID-19, Acute Respiratory Distress Syndrome, SARS-CoV-2, Hypoxemia
- Being tested
- Rejuveinix (RJX) Active Comparator, Placebo Comparator
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rejuveinix (RJX) Active ComparatorDrug
Also called RJX, Rejuveinix
Active drug comprised of: ascorbic acid, magnesium sulfate heptahydrate, cyanocobalamin, thiamine, riboflavin 5' phosphate, niacinamide, pyridoxine, calcium d-pantothenate, and sodium bicarbonate.
Placebo ComparatorDrug
Also called 0.9% Sodium Chloride in Water for Injection, USP., Normal Saline for Injection, USP
0.9% Sodium Chloride in Water for Injection a.k.a. Normal Saline for injection
| Study group | Role | What they receive |
|---|---|---|
| Arm A: RJX | Active comparator | 1. 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.
2. Standard of care (current antiviral and/or supportive care treatment currently in place at the institution for COVID-19 treatment).
3. 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. Receives: Drug: Rejuveinix (RJX) Active Comparator |
| Arm B: Placebo | Placebo comparator | 1. 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.
2. Standard of care (current antiviral and/or supportive care treatment currently in place at the institution for COVID-19 treatment).
3. Patients in Part 1 will not receive placebo.
4. Patients in Part 2 may be treated daily for up to 14 days. Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 60 days post-enrollment
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
Measured: Within 2 weeks
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
Measured: 60-days post enrollment
Secondary outcomes (6)
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
Measured: 60-days post enrollment
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)
Measured: 28-days post enrollment
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
Measured: 14-days post enrollment
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
Measured: 14-days post enrollment
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)
Measured: 14-days post enrollment
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
Measured: 60-days post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start25 Mar 2021
- Primary completionOct 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 237 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reven Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708340
- Sponsor's protocol ID
- RPI015
- Acronym
- RJX
- Status last verified
- Mar 2022
- First submitted
- 4 Jan 2021
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04708340
- Acronym / sponsor ID
- RJX / RPI015
- Conditions
- COVID-19, Acute Respiratory Distress Syndrome, SARS-CoV-2, Hypoxemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 237 participants (estimated)
- Lead sponsor
- Reven Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 13 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Arm A: RJX | Active comparator | Drug: Rejuveinix (RJX) Active Comparator1. 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. 2. Standard of care (current antiviral and/or supportive care treatment currently in place at the institution for COVID-19 treatment). 3. 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 B: Placebo | Placebo comparator | Drug: Placebo Comparator1. 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. 2. Standard of care (current antiviral and/or supportive care treatment currently in place at the institution for COVID-19 treatment). 3. Patients in Part 1 will not receive placebo. 4. Patients in Part 2 may be treated daily for up to 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rejuveinix (RJX) Active ComparatorAlso: RJX, RejuveinixActive drug comprised of: ascorbic acid, magnesium sulfate heptahydrate, cyanocobalamin, thiamine, riboflavin 5' phosphate, niacinamide, pyridoxine, calcium d-pantothenate, and sodium bicarbonate. | Drug | Arm A: RJX |
| Placebo ComparatorAlso: 0.9% Sodium Chloride in Water for Injection, USP., Normal Saline for Injection, USP0.9% Sodium Chloride in Water for Injection a.k.a. Normal Saline for injection | Drug | Arm B: Placebo |
Primary outcome
Safety as measured by DLTs and drug related SAE's
Time frame: Up to 60 days post-enrollment
• 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.
Time frame: Within 2 weeks
• 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
Time frame: 60-days post enrollment
• 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
6 secondary outcomes
Efficacy as measured by day of ICU care.
Time frame: 60-days post enrollment
Safety, Tolerability, Efficacy measured by mortality over 28 Days.
Time frame: 28-days post enrollment
Efficacy measured by mean change in baseline clinical status on Days 7 and 14.
Time frame: 14-days post enrollment
Efficacy measured by mean change in hospitalization days on Days 7 and 14.
Time frame: 14-days post enrollment
Efficacy measured by time to coming off supplemental oxygen on Days 7 and 14.
Time frame: 14-days post enrollment
Safety and Efficacy measured by time from first dose to renal therapy.
Time frame: 60-days post enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rejuveinix (RJX) Active Comparator in people with COVID-19 and Acute Respiratory Distress Syndrome, run by Reven Pharmaceuticals, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as measured by DLTs and drug related SAE's (time frame: Up to 60 days post-enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.