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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 : Recruiting
First Posted : January 13, 2021
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Oryn Therapeutics, LLC

Brief Summary:
Evaluate the safety and effect of ORTD-1 on COVID-19 related pneumonia.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: ORTD-1 low dose Drug: ORTD-1 mid dose Drug: ORTD-1 high dose Other: Vehicle control Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
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
Official Title: A Blinded, Controlled, Escalating Dose Study of ORTD-1 for Treatment of Hospitalized Patients With SARS-CoV-2 (COVID-19) Related Pneumonia.
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: ORTD-1 Low dose
Arm 1: ORTD-1
Drug: ORTD-1 low dose
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
Other Name: Intervention 1

Experimental: ORTD-1 Mid Dose
Arm 2: ORTD-1
Drug: ORTD-1 mid dose
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
Other Name: Intervention 1

Experimental: ORTD-1 High Dose
Arm 3 : ORTD-1
Drug: ORTD-1 high dose
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
Other Name: Intervention 1

Placebo Comparator: Vehicle Control
Arm 4: Vehicle control
Other: Vehicle control
Vehicle Control will be administered intravenously once daily for 5 consecutive days.
Other Name: Intervention 2




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Through Day 65 ]
    Number of participants with treatment-emergent adverse events

  2. Incidence of laboratory abnormalities [ Time Frame: Through Day 65 ]
    Number of participants with Grade 3 or higher laboratory abnormalities

  3. Incidence of anti-drug antibodies [ Time Frame: Through Day 65 ]
    Number of participants who develop antibodies to ORTD-1


Secondary Outcome Measures :
  1. 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.

  2. Percentage of days requiring supplemental oxygen [ Time Frame: Day 1-65 ]
    Percentage of days for which the patient requires supplemental oxygen will be recorded.

  3. Overall survival (OS) [ Time Frame: Day 1-65 ]
    Overall survival is defined as the time from enrollment until death from any cause.


Other Outcome Measures:
  1. 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.

  2. IL-6 [ Time Frame: Through Day 65 ]
    Level of the inflammatory biomarker IL-6 in blood will be measured.

  3. TNF-alpha [ Time Frame: Through Day 65 ]
    Level of the inflammatory biomarker TNF- alpha in blood will be measured.

  4. C-reactive protein [ Time Frame: Through Day 65 ]
    Level of the inflammatory biomarker C-reactive protein in blood will be measured.

  5. Serum ferritin [ Time Frame: Through Day 65 ]
    Level of serum ferritin in blood will be measured.

  6. D-dimer [ Time Frame: Through Day 65 ]
    Level of D-dimer in blood will be measured.

  7. 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



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

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

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): NCT04708236


Contacts
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Contact: Mary Poppenheimer 707-495-6621 mpoppenheimer@oryntherapeutics.com

Locations
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United States, California
UC Irvine Medical Center Recruiting
Orange, California, United States, 92868
Sponsors and Collaborators
Oryn Therapeutics, LLC
Investigators
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Principal Investigator: Alpesh Amin, MD Professor & Chair, Department of Medicine University of California, Irvine
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Responsible Party: Oryn Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT04708236    
Other Study ID Numbers: ORTD1-COV-001
First Posted: January 13, 2021    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021

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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 Oryn Therapeutics, LLC:
COVID-19 pneumonia
SARS-CoV-2
COVID-19 drug treatment
theta-defensins
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections