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

NCT04708236 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: ORTD1-COV-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19

Keywords

COVID-19 pneumonia; SARS-CoV-2; COVID-19 drug treatment; theta-defensins

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse events

  Number of participants with treatment-emergent adverse events

  Through Day 65

• Incidence of laboratory abnormalities

  Number of participants with Grade 3 or higher laboratory abnormalities

  Through Day 65

• Incidence of anti-drug antibodies

  Number of participants who develop antibodies to ORTD-1

  Through Day 65

Secondary Outcomes (3)

• Proportion of patients requiring intubation

  Day 1-65

• Percentage of days requiring supplemental oxygen

  Day 1-65

• Overall survival (OS)

  Day 1-65

Other Outcomes (7)

• Peripheral blood oxygen levels (SpO2)

  Day 1-Day 7, Day 14, Day 21, Day 28, Day 35, Day 65

• IL-6

  Through Day 65

• TNF-alpha

  Through Day 65

Study Arms (4)

ORTD-1 Low dose

EXPERIMENTAL

Arm 1: ORTD-1

Drug: ORTD-1 low dose

ORTD-1 Mid Dose

EXPERIMENTAL

Arm 2: ORTD-1

Drug: ORTD-1 mid dose

ORTD-1 High Dose

EXPERIMENTAL

Arm 3 : ORTD-1

Drug: ORTD-1 high dose

Vehicle Control

PLACEBO COMPARATOR

Arm 4: Vehicle control

Other: Vehicle control

Interventions

ORTD-1 low dose DRUG

ORTD-1 will be administered intravenously once daily for 5 consecutive days.

Also known as: Intervention 1

ORTD-1 Low dose

ORTD-1 mid dose DRUG

ORTD-1 will be administered intravenously once daily for 5 consecutive days.

Also known as: Intervention 1

ORTD-1 Mid Dose

ORTD-1 high dose DRUG

ORTD-1 will be administered intravenously once daily for 5 consecutive days.

Also known as: Intervention 1

ORTD-1 High Dose

Vehicle control OTHER

Vehicle Control will be administered intravenously once daily for 5 consecutive days.

Also known as: Intervention 2

Vehicle Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oryn Therapeutics, LLC: lead

Study Sites (1)

UC Irvine Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

rhesus-theta-defensin-1

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Alpesh Amin, MD

  Professor & Chair, Department of Medicine University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be allocated into 1 of 3 sequential escalating dose cohorts and randomized to ORTD-1 treatment versus vehicle control within each cohort.

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 13, 2021
• Study Start: April 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: July 1, 2021
• Last Updated: June 14, 2021

Record last verified: 2021-06

Locations

US (1)