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Trial record 3 of 4 for:    op-101

A Study to Evaluate OP-101 (Dendrimer N-acetyl-cysteine) in Severe Coronavirus Disease 2019 (COVID-19) Patients (PRANA)

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ClinicalTrials.gov Identifier: NCT04458298
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Orpheris, Inc.

Brief Summary:
The primary purpose is to evaluate the safety and tolerability of OP-101 and secondary purpose is to determine the effect of OP-101 reducing proinflammatory cytokines after a single dose in severe COVID-19 Patients.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: OP-101 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of OP-101 (Dendrimer N-acetyl-cysteine) in Patients With Severe COVID-19
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021


Arm Intervention/treatment
Experimental: Cohort A: OP-101 2 mg/kg
Participants will receive a single intravenous (IV) infusion of OP-101 2 milligram per kilogram (mg/kg) on Day 1.
Drug: OP-101
OP-101 infusion will be administered intravenously.

Experimental: Cohort B: OP-101 4 mg/kg
Participants will receive a single IV infusion of OP-101 4 mg/kg on Day 1.
Drug: OP-101
OP-101 infusion will be administered intravenously.

Experimental: Cohort C: OP-101 8 mg/kg
Participants will receive a single IV infusion of OP-101 8 mg/kg on Day 1.
Drug: OP-101
OP-101 infusion will be administered intravenously.

Placebo Comparator: Cohort D: Placebo
Participants will receive a single IV infusion of matching placebo on Day 1.
Drug: Placebo
Matching placebo infusion will be administered intravenously.




Primary Outcome Measures :
  1. Number of Participants with Treatment Emergent Adverse Events Graded as Assessed by CTCAE Version 4.0 [ Time Frame: Up to Day 60 ]
    Number of participants with treatment emergent adverse events will be evaluated as a measure of safety and tolerability of OP-101 by monitoring and documenting all adverse events, which include laboratory test variables.


Secondary Outcome Measures :
  1. Time to Improvement (2 points) in Clinical Status Assessment Using the World Health Organization 7-Point Ordinal Scale (WHO 7OS) [ Time Frame: Up to Day 30 ]
    WHO-7 is a 7 point ordinal scale for clinical improvement with scores ranging from 0 to 7 where 0= uninfected, 1= no limitation of activities (ambulatory), 2= limitation of activities (ambulatory), 3= hospitalized, no oxygen therapy (hospitalized mild disease), 4= Hospitalized, oxygen by mask or nasal prongs (hospitalized mild disease), 5= Hospitalized, noninvasive ventilation or high-flow oxygen (hospitalized severe disease), 6= Hospitalized, intubation and mechanical ventilation (hospitalized severe disease), 7= Hospitalized, ventilation + additional organ support - pressors, renal replacement therapy, ECMO.

  2. Time to Resolution of Fever for at least 48 hours Without Antipyretics for Patients with Documented Fever (>=37.2 degree celsius [oral], or >=37.8 degree celsius [rectal], or >=38.0 degree celsius [tympanic]) [ Time Frame: Up to Day 30 ]
  3. Time to Improvement in Oxygenation for at least 48 hours [ Time Frame: Up to Day 30 ]
    Improvement in oxygenation is defined by increase in pulse oxygen saturation/fraction of inspired oxygen (SpO2/FiO2) of >=50 compared with nadir SpO2/FiO2.

  4. Change from Baseline in the World Health Organization (WHO)-7 Point Ordinal Scale [ Time Frame: Baseline up to Day 30 ]
    WHO-7 is a 7 point ordinal scale for clinical improvement with scores ranging from 0 to 7 where 0= uninfected, 1= no limitation of activities (ambulatory), 2= limitation of activities (ambulatory), 3= hospitalized, no oxygen therapy (hospitalized mild disease), 4= Hospitalized, oxygen by mask or nasal prongs (hospitalized mild disease), 5= Hospitalized, noninvasive ventilation or high-flow oxygen (hospitalized severe disease), 6= Hospitalized, intubation and mechanical ventilation (hospitalized severe disease), 7= Hospitalized, ventilation + additional organ support - pressors, renal replacement therapy, ECMO.

  5. Time to Discharge from Clinic or Hospital or to National Early Warning Score 2 (NEWS2) of <=2 and maintained for 24 hours [ Time Frame: Up to Day 30 ]
    NEWS2 consists of: Physiological Parameters: Respiration rate (per minute), SpO2 Scale 1 (%), SpO2 Scale 2 (%), Use of Air or oxygen, Systolic blood pressure (mmHg), Pulse (per minute), Consciousness, Temperature (°C).

  6. Percentage of Patients Alive and not Using Supplemental Oxygen at Time of Discharge from Hospital/Clinic or Day 30 [ Time Frame: Up to Day 30 ]
  7. Number of Days of Resting Respiratory Rate of more than 24 breath/min [ Time Frame: Up to Day 30 ]
  8. Number of Days with Hypoxemia [ Time Frame: Up to Day 30 ]
    Hypoxemia is defined by Saturation of Peripheral Oxygen (SpO2) of less than (<) 95 percent (%) on room air or acute respiratory distress syndrome (ARDS).

  9. Number of Days of Supplemental Oxygen use [ Time Frame: Up to Day 30 ]
  10. Number of Ventilator-free Days [ Time Frame: Up to Day 28 ]
  11. Number of Days in Intensive Care Unit (ICU) [ Time Frame: Up to Day 30 ]
  12. Number of Days of Hospitalization for Survivors [ Time Frame: Up to Day 30 ]
  13. Number of Participants with all cause deaths [ Time Frame: Up to Day 30 ]
  14. Percent change from baseline in Proinflammatory Cytokines [ Time Frame: Baseline up to Day 30 ]
    Percent change from baseline in proinflammatory cytokines (C-reactive protein [CRP], ferritin, and interleukin-6 [IL-6]) will be reported.

  15. Incidence of Drug-related Serious Adverse Events (SAEs) [ Time Frame: Up to Day 60 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Body mass index (BMI) less than or equal to (<=) 35 kilogram per meter square (kg/m^2)
  • Positive laboratory test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or respiratory infection with recent exposure to a person with laboratory-proven SARS-CoV-2
  • Hypoxemia defined by saturation of peripheral oxygen (SpO2) of less than (<) 95 percent (%) on room air or Acute respiratory distress syndrome (ARDS)
  • Occurrence of at least two of the following criteria: fever greater than (>) 38.0 degree celsius, tachycardia >90 beats/minute, tachypnea >20 breaths/minute, leucocytosis >12*109 per liter (/L) or leucopoenia <4 *109/L
  • Participants must have an estimated glomerular filtration rate of greater than or equal to (>=) 45 milliliter per minute per 1.73 meter square (mL/min/1.73 m^2) at screening

Key Exclusion Criteria:

  • Not expected to survive for more than 24 hours
  • Severe chronic obstructive pulmonary disease requiring long-term home oxygen therapy or mechanical ventilation (noninvasive ventilation or via tracheotomy) except for continuous positive airway pressure or bi-level positive airway pressure used solely for sleep-disordered breathing
  • Acute left ventricular failure or myocardial infarction
  • Currently receiving extracorporeal membrane oxygenation (ECMO) therapy
  • Receiving renal dialysis therapy for chronic renal failure
  • Concurrent treatment with immune modulatory study drugs (e.g., anti-IL6 antibodies, Janus kinase (JAK) kinase inhibitors) or other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 within 30 days or 5 half-lives, whichever is longer, prior to dosing with OP-101; except for those that have received FDA emergency-use authorization and have become standard of care (SOC). Concurrent treatment with corticosteroids is permitted if participant has documented continued hypoxemia (SpO2 of <95% on room air) and hyper-inflammation (CRP>=10mg/L) at screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04458298


Contacts
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Contact: Jeffrey L. Cleland, Executive Chair, Co-founder +1 650 241 1697 cleland@orpheris.com

Locations
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United States, California
Research Site Recruiting
Loma Linda, California, United States, 92354
Principal Investigator: H. Bryant Nguyen, MD         
United States, Florida
Research site Recruiting
Fort Lauderdale, Florida, United States, 33316
Principal Investigator: Sunil Kumar, MD         
United States, Georgia
Research Site Recruiting
Atlanta, Georgia, United States, 30342
Principal Investigator: Ishan Mehta, MD         
United States, Maryland
Research site Recruiting
Baltimore, Maryland, United States, 21287
Principal Investigator: Nauder Faraday, MD         
United States, Texas
Research Site Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Aaron Gusdon, MD         
Sponsors and Collaborators
Orpheris, Inc.
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Responsible Party: Orpheris, Inc.
ClinicalTrials.gov Identifier: NCT04458298    
Other Study ID Numbers: OP-101-004
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Orpheris, Inc.:
SARS-COV-2
Coronavirus
Cytokine storm
Acute respiratory distress syndrome
Inflammation
IL-6
Treatment
OP-101