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

Oryn Therapeutics

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: COVID-19

Treatments: Drug: ORTD-1 mid dose; Drug: ORTD-1 high dose; Other: Vehicle control; Drug: ORTD-1 low dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT04708236

ORTD1-COV-001

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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0 participants in 4 patient groups, including a placebo group

ORTD-1 Low dose

Experimental group

Description:

Arm 1: ORTD-1

Treatment:

Drug: ORTD-1 low dose

ORTD-1 Mid Dose

Experimental group

Description:

Arm 2: ORTD-1

Treatment:

Drug: ORTD-1 mid dose

ORTD-1 High Dose

Experimental group

Description:

Arm 3 : ORTD-1

Treatment:

Drug: ORTD-1 high dose

Vehicle Control

Placebo Comparator group

Description:

Arm 4: Vehicle control

Treatment:

Other: Vehicle control