Coronavirus InfectionPhase 3NCT04326426
ODYSSEY: A Study to Investigate the Efficacy of Tradipitant in Treating Severe or Critical COVID-19 Infection
A Phase 3 study testing Tradipitant in people with Coronavirus Infection, run by Vanda Pharmaceuticals at 1 site in United States.
Trial summary
This is a randomized, double-blind placebo-controlled trial to investigate the efficacy and safety of tradipitant 85 mg orally given twice daily to treat inflammatory lung injury associated with severe or critical COVID-19 infection. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronavirus Infection
- What is being tested?
- Tradipitant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2020to 31 Aug 2020
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-90
- Confirmed laboratory COVID-19 infection by RT-PCR
- Meeting severe or critical criteria of COVID-19 infection as defined at treating hospital
- Confirmed pneumonia by chest radiograph or computed tomography
- Fever defined as temperature ≥ 36.6 °C armpit, ≥ 37.2 °C oral, or ≥ 37.8 °C rectal
- Oxygen saturation less than 92%
Who cannot join
- Recent use of illicit drugs or alcohol abuse
- Known allergy to tradipitant or other neurokinin-1 antagonists
- Pregnancy
- Known HIV, HBV, or HCV infection
- Malignant tumor, other serious systemic diseases
- Inability to provide informed consent or to have an authorized relative or designated person provide informed consent, or to comply with the protocol requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Lenox Hill Hospital Northwell Health
New York, New York, 10075
About this study
Official title: ODYSSEY: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Treating Inflammatory Lung Injury and Improving Clinical Outcomes Associated With Severe or Critical COVID-19 Infection
This is a randomized, double-blind placebo-controlled trial to investigate the efficacy and safety of tradipitant 85 mg orally given twice daily to treat inflammatory lung injury associated with severe or critical COVID-19 infection.
On evaluation for enrollment, participant will need to meet all inclusion and exclusion criteria. If participant consents, they will be randomized 1:1 to treatment with either tradipitant 85 mg PO BID or placebo in addition to standard of care for COVID-19 infection as per the protocol at the treating hospital. NEWS 2 will be assessed at screening and daily following randomization. Inflammatory lab markers as detailed should be collected once per day in the morning, preferably at the same time every morning. All enrolled participants will have whole blood collected for whole genome sequencing.
- Conditions
- Coronavirus Infection
- Being tested
- Tradipitant, Placebo
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TradipitantDrug
Neurokinin-1 antagonist
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Tradipitant | Experimental | Tradipitant 85 mg PO BID Receives: Drug: Tradipitant |
| Placebo | Placebo comparator | 2 capsules of matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to improvement on a 7-point ordinal scale as compared to baseline
Measured: 14 days or discharge
Secondary outcomes (9)
Treatment and prevention of inflammatory lung injury as measured by change in baseline of interleukin-6 (IL-6)
Measured: 14 days or discharge
Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples
Measured: 14 days or discharge
In-hospital mortality
Measured: 14 days or discharge
Mean change in NEWS2 score from baseline
Measured: 14 days or discharge
Understand the effect of genetics for treatment response through whole genome sequence of the participant and the COVID-19 virus
Measured: 14 days or discharge
Reduction from baseline of NRS for cough
Measured: 14 days or discharge
Reduction from baseline of NRS for nausea
Measured: 14 days or discharge
Time to normalization of fever for at least 48 hours
Measured: 14 days or discharge
Time to improvement in oxygenation for at least 48 hours
Measured: 14 days or discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start13 Apr 2020
- Primary completion1 Aug 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326426
- Sponsor's protocol ID
- VLY-686-3501
- Status last verified
- Apr 2020
- First submitted
- 26 Mar 2020
- Last updated
- 20 Apr 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Smieszek SP, Przychodzen BP, Polymeropoulos VM, Polymeropoulos CM, Polymeropoulos MH. Assessing the potential correlation of polymorphisms in the IL6R with relative IL6 elevation in severely ill COVID-19 patients'. Cytokine. 2021 Dec;148:155662. doi: 10.1016/j.cyto.2021.155662. Epub 2021 Jul 29.
PubMed 34353696
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ODYSSEY: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Treating Inflammatory Lung Injury and Improving Clinical Outcomes Associated With Severe or Critical COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04326426
- Acronym / sponsor ID
- VLY-686-3501
- Conditions
- Coronavirus Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 30 Mar 2020 (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.
This is a randomized, double-blind placebo-controlled trial to investigate the efficacy and safety of tradipitant 85 mg orally given twice daily to treat inflammatory lung injury associated with severe or critical COVID-19 infection.
On evaluation for enrollment, participant will need to meet all inclusion and exclusion criteria. If participant consents, they will be randomized 1:1 to treatment with either tradipitant 85 mg PO BID or placebo in addition to standard of care for COVID-19 infection as per the protocol at the treating hospital. NEWS 2 will be assessed at screening and daily following randomization. Inflammatory lab markers as detailed should be collected once per day in the morning, preferably at the same time every morning. All enrolled participants will have whole blood collected for whole genome sequencing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tradipitant | Experimental | Drug: TradipitantTradipitant 85 mg PO BID |
| Placebo | Placebo comparator | Drug: Placebo2 capsules of matching placebo |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18-90
- Confirmed laboratory COVID-19 infection by RT-PCR
- Meeting severe or critical criteria of COVID-19 infection as defined at treating hospital
- Confirmed pneumonia by chest radiograph or computed tomography
- Fever defined as temperature ≥ 36.6 °C armpit, ≥ 37.2 °C oral, or ≥ 37.8 °C rectal
Key exclusion criteria (6 listed)
- Recent use of illicit drugs or alcohol abuse
- Known allergy to tradipitant or other neurokinin-1 antagonists
- Pregnancy
- Known HIV, HBV, or HCV infection
- Malignant tumor, other serious systemic diseases
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 |
|---|---|---|
| TradipitantNeurokinin-1 antagonist | Drug | Tradipitant |
| PlaceboMatching placebo | Drug | Placebo |
Primary outcome
Time to improvement on a 7-point ordinal scale as compared to baseline
Time frame: 14 days or discharge
9 secondary outcomes
Treatment and prevention of inflammatory lung injury as measured by change in baseline of interleukin-6 (IL-6)
Time frame: 14 days or discharge
Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples
Time frame: 14 days or discharge
In-hospital mortality
Time frame: 14 days or discharge
Mean change in NEWS2 score from baseline
Time frame: 14 days or discharge
Understand the effect of genetics for treatment response through whole genome sequence of the participant and the COVID-19 virus
Time frame: 14 days or discharge
Reduction from baseline of NRS for cough
Time frame: 14 days or discharge
Reduction from baseline of NRS for nausea
Time frame: 14 days or discharge
Time to normalization of fever for at least 48 hours
Time frame: 14 days or discharge
Time to improvement in oxygenation for at least 48 hours
Time frame: 14 days or discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Derived from this study: PubMed 34353696Smieszek SP, Przychodzen BP, Polymeropoulos VM, Polymeropoulos CM, Polymeropoulos MH. Assessing the potential correlation of polymorphisms in the IL6R with relative IL6 elevation in severely ill COVID-19 patients'. Cytokine. 2021 Dec;148:155662. doi: 10.1016/j.cyto.2021.155662. Epub 2021 Jul 29.
Related trials for Coronavirus Infection
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
RecruitingPhase 4
A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Formulations
SARS-CoV-2
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory Failure
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tradipitant in people with Coronavirus Infection, run by Vanda Pharmaceuticals 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 6 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 20 Apr 2020. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Time to improvement on a 7-point ordinal scale as compared to baseline (time frame: 14 days or discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04326426, which also lists 1 linked publication.
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 20 Apr 2020; AzTrials last refreshed its copy on 8 Nov 2026.