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A Study of ORTD-1 in Patients Hospitalized With COVID-19 Related Pneumonia

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ClinicalTrials.gov Identifier: NCT04708236
Recruitment Status : Withdrawn (recruitment)
First Posted : January 13, 2021
Last Update Posted : June 14, 2021
Sponsor:
Information provided by (Responsible Party):
Oryn Therapeutics, LLC

Tracking Information
First Submitted Date  ICMJE January 8, 2021
First Posted Date  ICMJE January 13, 2021
Last Update Posted Date June 14, 2021
Estimated Study Start Date  ICMJE April 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2021)
  • Incidence of adverse events [ Time Frame: Through Day 65 ]
    Number of participants with treatment-emergent adverse events
  • Incidence of laboratory abnormalities [ Time Frame: Through Day 65 ]
    Number of participants with Grade 3 or higher laboratory abnormalities
  • Incidence of anti-drug antibodies [ Time Frame: Through Day 65 ]
    Number of participants who develop antibodies to ORTD-1
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2021)
  • Proportion of patients requiring intubation [ Time Frame: Day 1-65 ]
    The requirement of intubation and invasive ventilation will be assessed for patients at each visit.
  • Percentage of days requiring supplemental oxygen [ Time Frame: Day 1-65 ]
    Percentage of days for which the patient requires supplemental oxygen will be recorded.
  • Overall survival (OS) [ Time Frame: Day 1-65 ]
    Overall survival is defined as the time from enrollment until death from any cause.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 12, 2021)
  • Peripheral blood oxygen levels (SpO2) [ Time Frame: Day 1-Day 7, Day 14, Day 21, Day 28, Day 35, Day 65 ]
    SpO2 over time will be measured by pulse oximetry.
  • IL-6 [ Time Frame: Through Day 65 ]
    Level of the inflammatory biomarker IL-6 in blood will be measured.
  • TNF-alpha [ Time Frame: Through Day 65 ]
    Level of the inflammatory biomarker TNF- alpha in blood will be measured.
  • C-reactive protein [ Time Frame: Through Day 65 ]
    Level of the inflammatory biomarker C-reactive protein in blood will be measured.
  • Serum ferritin [ Time Frame: Through Day 65 ]
    Level of serum ferritin in blood will be measured.
  • D-dimer [ Time Frame: Through Day 65 ]
    Level of D-dimer in blood will be measured.
  • Serum concentration of ORTD-1 (Pharmacokinetics) [ Time Frame: Day 1-Day 6, Day 14, Day 21, Day 35, Day 65 ]
    Serum concentration of ORTD-1 will be measured following IV infusion and during follow-up
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study of ORTD-1 in Patients Hospitalized With COVID-19 Related Pneumonia
Official Title  ICMJE A Blinded, Controlled, Escalating Dose Study of ORTD-1 for Treatment of Hospitalized Patients With SARS-CoV-2 (COVID-19) Related Pneumonia.
Brief Summary Evaluate the safety and effect of ORTD-1 on COVID-19 related pneumonia.
Detailed Description This is a randomized, blinded, vehicle-controlled dose-escalation study. Initial enrollment and treatment will be conducted as an inpatient study. Patients will be randomized 2:1, ORTD-1 treatment versus vehicle control. Patients will be allocated into 1 of 3 sequential escalating dose cohorts. Blinded study drug will be infused intravenously once daily for 5 consecutive days.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Patients will be allocated into 1 of 3 sequential escalating dose cohorts and randomized to ORTD-1 treatment versus vehicle control within each cohort.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: ORTD-1 low dose
    ORTD-1 will be administered intravenously once daily for 5 consecutive days.
    Other Name: Intervention 1
  • Drug: ORTD-1 mid dose
    ORTD-1 will be administered intravenously once daily for 5 consecutive days.
    Other Name: Intervention 1
  • Drug: ORTD-1 high dose
    ORTD-1 will be administered intravenously once daily for 5 consecutive days.
    Other Name: Intervention 1
  • Other: Vehicle control
    Vehicle Control will be administered intravenously once daily for 5 consecutive days.
    Other Name: Intervention 2
Study Arms  ICMJE
  • Experimental: ORTD-1 Low dose
    Arm 1: ORTD-1
    Intervention: Drug: ORTD-1 low dose
  • Experimental: ORTD-1 Mid Dose
    Arm 2: ORTD-1
    Intervention: Drug: ORTD-1 mid dose
  • Experimental: ORTD-1 High Dose
    Arm 3 : ORTD-1
    Intervention: Drug: ORTD-1 high dose
  • Placebo Comparator: Vehicle Control
    Arm 4: Vehicle control
    Intervention: Other: Vehicle control
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 9, 2021)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2021)
18
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Positive RT-PCR assay for SARS CoV-2 in a respiratory tract sample
  • Hospitalized for COVID-19
  • Radiographic diagnosis of pneumonia
  • Respiratory insufficiency
  • Receiving pharmacologic thromboprophylaxis

Exclusion Criteria:

  • Premorbid abnormal pulmonary function or disease
  • Concurrent or prior intubation or ventilated support for COVID-19
  • Receiving systemic corticosteroids or other immunomodulators or immunosuppressant drugs
  • Previous hospitalization for COVID-19
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 NCT04708236
Other Study ID Numbers  ICMJE ORTD1-COV-001
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 Not Provided
Responsible Party Oryn Therapeutics, LLC
Study Sponsor  ICMJE Oryn Therapeutics, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alpesh Amin, MD Professor & Chair, Department of Medicine University of California, Irvine
PRS Account Oryn Therapeutics, LLC
Verification Date June 2021

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