COVID-19Phase 1/2NCT04708236
A Study of ORTD-1 in Patients Hospitalized With COVID-19 Related Pneumonia
A Phase 1/2 study testing ORTD-1 low dose, ORTD-1 mid dose and ORTD-1 high dose in people with COVID-19, run by Oryn Therapeutics, LLC at 1 site in United States.
Trial summary
Evaluate the safety and effect of ORTD-1 on COVID-19 related pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- ORTD-1 low dose, ORTD-1 mid dose and ORTD-1 high dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2021to Jul 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Blinded, Controlled, Escalating Dose Study of ORTD-1 for Treatment of Hospitalized Patients With SARS-CoV-2 (COVID-19) Related Pneumonia.
Evaluate the safety and effect of ORTD-1 on COVID-19 related pneumonia.
Read the 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.
- Conditions
- COVID-19
- Being tested
- ORTD-1 low dose, ORTD-1 mid dose, ORTD-1 high dose, Vehicle control
- Keywords
- COVID-19 pneumonia, SARS-CoV-2, COVID-19 drug treatment, theta-defensins
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORTD-1 low doseDrug
Also called Intervention 1
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
ORTD-1 mid doseDrug
Also called Intervention 1
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
ORTD-1 high doseDrug
Also called Intervention 1
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
Vehicle controlOther
Also called Intervention 2
Vehicle Control will be administered intravenously once daily for 5 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| ORTD-1 Low dose | Experimental | Arm 1: ORTD-1 Receives: Drug: ORTD-1 low dose |
| ORTD-1 Mid Dose | Experimental | Arm 2: ORTD-1 Receives: Drug: ORTD-1 mid dose |
| ORTD-1 High Dose | Experimental | Arm 3 : ORTD-1 Receives: Drug: ORTD-1 high dose |
| Vehicle Control | Placebo comparator | Arm 4: Vehicle control Receives: Other: Vehicle control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Number of participants with treatment-emergent adverse events
Measured: Through Day 65
Incidence of laboratory abnormalities
Number of participants with Grade 3 or higher laboratory abnormalities
Measured: Through Day 65
Incidence of anti-drug antibodies
Number of participants who develop antibodies to ORTD-1
Measured: Through Day 65
Secondary outcomes (3)
Proportion of patients requiring intubation
The requirement of intubation and invasive ventilation will be assessed for patients at each visit.
Measured: Day 1-65
Percentage of days requiring supplemental oxygen
Percentage of days for which the patient requires supplemental oxygen will be recorded.
Measured: Day 1-65
Overall survival (OS)
Overall survival is defined as the time from enrollment until death from any cause.
Measured: Day 1-65
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study startApr 2021 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionJul 2021 (estimated)
Why it stopped: recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oryn Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alpesh Amin, MD, Principal investigator, Professor & Chair, Department of Medicine University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708236
- Sponsor's protocol ID
- ORTD1-COV-001
- Status last verified
- Jun 2021
- First submitted
- 8 Jan 2021
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blinded, Controlled, Escalating Dose Study of ORTD-1 for Treatment of Hospitalized Patients With SARS-CoV-2 (COVID-19) Related Pneumonia.
- ClinicalTrials.gov ID
- NCT04708236
- Acronym / sponsor ID
- ORTD1-COV-001
- Conditions
- COVID-19
- Keywords
- COVID-19 pneumonia, SARS-CoV-2, COVID-19 drug treatment, theta-defensins
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oryn Therapeutics, LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2021 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 13 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety and effect of ORTD-1 on COVID-19 related pneumonia.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| ORTD-1 Low dose | Experimental | Drug: ORTD-1 low doseArm 1: ORTD-1 |
| ORTD-1 Mid Dose | Experimental | Drug: ORTD-1 mid doseArm 2: ORTD-1 |
| ORTD-1 High Dose | Experimental | Drug: ORTD-1 high doseArm 3 : ORTD-1 |
| Vehicle Control | Placebo comparator | Other: Vehicle controlArm 4: Vehicle control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORTD-1 low doseAlso: Intervention 1ORTD-1 will be administered intravenously once daily for 5 consecutive days. | Drug | ORTD-1 Low dose |
| ORTD-1 mid doseAlso: Intervention 1ORTD-1 will be administered intravenously once daily for 5 consecutive days. | Drug | ORTD-1 Mid Dose |
| ORTD-1 high doseAlso: Intervention 1ORTD-1 will be administered intravenously once daily for 5 consecutive days. | Drug | ORTD-1 High Dose |
| Vehicle controlAlso: Intervention 2Vehicle Control will be administered intravenously once daily for 5 consecutive days. | Other | Vehicle Control |
Primary outcome
Incidence of adverse events
Time frame: Through Day 65
Number of participants with treatment-emergent adverse events
Incidence of laboratory abnormalities
Time frame: Through Day 65
Number of participants with Grade 3 or higher laboratory abnormalities
Incidence of anti-drug antibodies
Time frame: Through Day 65
Number of participants who develop antibodies to ORTD-1
3 secondary outcomes
Proportion of patients requiring intubation
Time frame: Day 1-65
Percentage of days requiring supplemental oxygen
Time frame: Day 1-65
Overall survival (OS)
Time frame: Day 1-65
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alpesh Amin, MD principal investigator
Professor & Chair, Department of Medicine University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ORTD-1 low dose, ORTD-1 mid dose and ORTD-1 high dose in people with COVID-19, run by Oryn Therapeutics, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Through Day 65). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.