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

COVID-19 Clinical Trial

Official title:

A Blinded, Controlled, Escalating Dose Study of ORTD-1 for Treatment of Hospitalized Patients With SARS-CoV-2 (COVID-19) Related Pneumonia.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04708236
• Other study ID #: ORTD1-COV-001
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: April 2021
• Est. completion date: July 2021

Study information

• Verified date: June 2021
• Source: Oryn Therapeutics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Pneumonia

Intervention

Drug:
• ORTD-1 low dose
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
• ORTD-1 mid dose
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
• ORTD-1 high dose
ORTD-1 will be administered intravenously once daily for 5 consecutive days.

Other:
• Vehicle control
Vehicle Control will be administered intravenously once daily for 5 consecutive days.

Locations

Country	Name	City	State
United States	UC Irvine Medical Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
Oryn Therapeutics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Peripheral blood oxygen levels (SpO2)	SpO2 over time will be measured by pulse oximetry.	Day 1-Day 7, Day 14, Day 21, Day 28, Day 35, Day 65
Other	IL-6	Level of the inflammatory biomarker IL-6 in blood will be measured.	Through Day 65
Other	TNF-alpha	Level of the inflammatory biomarker TNF- alpha in blood will be measured.	Through Day 65
Other	C-reactive protein	Level of the inflammatory biomarker C-reactive protein in blood will be measured.	Through Day 65
Other	Serum ferritin	Level of serum ferritin in blood will be measured.	Through Day 65
Other	D-dimer	Level of D-dimer in blood will be measured.	Through Day 65
Other	Serum concentration of ORTD-1 (Pharmacokinetics)	Serum concentration of ORTD-1 will be measured following IV infusion and during follow-up	Day 1-Day 6, Day 14, Day 21, Day 35, Day 65
Primary	Incidence of adverse events	Number of participants with treatment-emergent adverse events	Through Day 65
Primary	Incidence of laboratory abnormalities	Number of participants with Grade 3 or higher laboratory abnormalities	Through Day 65
Primary	Incidence of anti-drug antibodies	Number of participants who develop antibodies to ORTD-1	Through Day 65
Secondary	Proportion of patients requiring intubation	The requirement of intubation and invasive ventilation will be assessed for patients at each visit.	Day 1-65
Secondary	Percentage of days requiring supplemental oxygen	Percentage of days for which the patient requires supplemental oxygen will be recorded.	Day 1-65
Secondary	Overall survival (OS)	Overall survival is defined as the time from enrollment until death from any cause.	Day 1-65