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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04458298
Recruitment Status : Active, not recruiting
First Posted : July 7, 2020
Last Update Posted : July 29, 2021
Sponsor:
Information provided by (Responsible Party):
Orpheris, Inc.

Tracking Information
First Submitted Date  ICMJE June 29, 2020
First Posted Date  ICMJE July 7, 2020
Last Update Posted Date July 29, 2021
Actual Study Start Date  ICMJE August 11, 2020
Estimated Primary Completion Date June 2, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2020)
  • 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.
  • 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 ]
  • 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.
  • 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.
  • 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).
  • 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 ]
  • Number of Days of Resting Respiratory Rate of more than 24 breath/min [ Time Frame: Up to Day 30 ]
  • 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).
  • Number of Days of Supplemental Oxygen use [ Time Frame: Up to Day 30 ]
  • Number of Ventilator-free Days [ Time Frame: Up to Day 28 ]
  • Number of Days in Intensive Care Unit (ICU) [ Time Frame: Up to Day 30 ]
  • Number of Days of Hospitalization for Survivors [ Time Frame: Up to Day 30 ]
  • Number of Participants with all cause deaths [ Time Frame: Up to Day 30 ]
  • 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.
  • Incidence of Drug-related Serious Adverse Events (SAEs) [ Time Frame: Up to Day 60 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate OP-101 (Dendrimer N-acetyl-cysteine) in Severe Coronavirus Disease 2019 (COVID-19) Patients
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: OP-101
    OP-101 infusion will be administered intravenously.
  • Drug: Placebo
    Matching placebo infusion will be administered intravenously.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: OP-101
  • Experimental: Cohort B: OP-101 4 mg/kg
    Participants will receive a single IV infusion of OP-101 4 mg/kg on Day 1.
    Intervention: Drug: OP-101
  • Experimental: Cohort C: OP-101 8 mg/kg
    Participants will receive a single IV infusion of OP-101 8 mg/kg on Day 1.
    Intervention: Drug: OP-101
  • Placebo Comparator: Cohort D: Placebo
    Participants will receive a single IV infusion of matching placebo on Day 1.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 2, 2020)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2, 2022
Estimated Primary Completion Date June 2, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04458298
Other Study ID Numbers  ICMJE OP-101-004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Orpheris, Inc.
Study Sponsor  ICMJE Orpheris, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Orpheris, Inc.
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP