Suspended

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

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What is being tested

ORTD-1 low dose

+ ORTD-1 mid dose

+ ORTD-1 high dose

DrugOther
Who is being recruted

COVID-19+9

+ Coronaviridae Infections

+ Infections

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1 & 2
Interventional
Study Start: April 2021
See protocol details

Summary

Principal SponsorOryn Therapeutics, LLC
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2021

Actual date on which the first participant was enrolled.

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.

Official TitleA Blinded, Controlled, Escalating Dose Study of ORTD-1 for Treatment of Hospitalized Patients With SARS-CoV-2 (COVID-19) Related Pneumonia.
NCT04708236
Principal SponsorOryn Therapeutics, LLC
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

COVID-19Coronaviridae InfectionsInfectionsLung DiseasesPneumoniaPneumonia, ViralRespiratory Tract DiseasesRespiratory Tract InfectionsRNA Virus InfectionsVirus DiseasesCoronavirus InfectionsNidovirales Infections

Criteria

5 inclusion criteria required to participate
Positive RT-PCR assay for SARS CoV-2 in a respiratory tract sample
Hospitalized for COVID-19
Radiographic diagnosis of pneumonia
Respiratory insufficiency
Show More Criteria
4 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Arm 1: ORTD-1

Group II

Experimental
Arm 2: ORTD-1

Group III

Experimental
Arm 3 : ORTD-1

Group IV

Placebo
Arm 4: Vehicle control

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

UC Irvine Medical Center

Orange, United StatesOpen UC Irvine Medical Center in Google Maps
SuspendedOne Study Center