Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04326426
Other study ID # VLY-686-3501
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received
Last updated
Start date April 13, 2020
Est. completion date August 31, 2020

Study information

Verified date April 2020
Source Vanda Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 300
Est. completion date August 31, 2020
Est. primary completion date August 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- 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%

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tradipitant
Neurokinin-1 antagonist
Placebo
Matching placebo

Locations

Country Name City State
United States Lenox Hill Hospital Northwell Health New York New York

Sponsors (1)

Lead Sponsor Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to improvement on a 7-point ordinal scale as compared to baseline 14 days or discharge
Secondary Treatment and prevention of inflammatory lung injury as measured by change in baseline of interleukin-6 (IL-6) 14 days or discharge
Secondary Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples 14 days or discharge
Secondary In-hospital mortality 14 days or discharge
Secondary Mean change in NEWS2 score from baseline 14 days or discharge
Secondary Understand the effect of genetics for treatment response through whole genome sequence of the participant and the COVID-19 virus 14 days or discharge
Secondary Reduction from baseline of NRS for cough 14 days or discharge
Secondary Reduction from baseline of NRS for nausea 14 days or discharge
Secondary Time to normalization of fever for at least 48 hours 14 days or discharge
Secondary Time to improvement in oxygenation for at least 48 hours 14 days or discharge
See also
  Status Clinical Trial Phase
Completed NCT04369456 - Blood Biomarkers as Predictors of COVID-19 Disease Progression in Recently Infected Kidney Transplant Patients N/A
Completed NCT04527471 - Pilot Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19 Phase 2
Recruiting NCT04410510 - P2Et Extract in the Symptomatic Treatment of Subjects With COVID-19 Phase 2/Phase 3
Withdrawn NCT04383899 - Role of Ibuprofen and Other Medicines on Severity of Coronavirus Disease 2019
Completed NCT04542915 - COVID-19-Related Health and Practices Among Dental Hygienists
Not yet recruiting NCT04400019 - Prevention of COVID19 Infection in Nursing Homes by Chemoprophylaxis With Hydroxychloroquine (PREVICHARM) Phase 2/Phase 3
Suspended NCT04385771 - Cytokine Adsorption in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation N/A
Terminated NCT04954014 - Pilot Study of Single Dose Bevacizumab as Treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 Patients Phase 2
Completed NCT04532632 - Taste and Smell Impairment in Critically Ill COVID-19 Patients
Terminated NCT04530448 - Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization Phase 4
Completed NCT04413435 - Clinical Characteristics of Critically Ill Patients With COVID-19
Terminated NCT05593770 - International Sites: Novel Experimental COVID-19 Therapies Affecting Host Response Phase 2/Phase 3
Completed NCT04510493 - Canakinumab in Patients With COVID-19 and Type 2 Diabetes Phase 3
Active, not recruiting NCT04587219 - The Study of "Gam-COVID-Vac" Vaccine Against COVID-19 With the Participation of Volunteers of 60 y.o and Older Phase 2
Withdrawn NCT05430958 - Safety, Tolerability and Immunogenicity of INO-4800 for COVID19 in Healthy Volunteers Phase 1
Completed NCT04596579 - SARS-CoV-2 (COVID-19) Immune Surveillance Among a Population Based Sample of Adults in Florida
Completed NCT04405934 - COG-UK Project Hospital-Onset COVID-19 Infections Study N/A
Enrolling by invitation NCT04484025 - SPI-1005 Treatment in Moderate COVID-19 Patients Phase 2
Terminated NCT04442230 - NasoVAX in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19) Phase 2
Terminated NCT04642638 - Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure Phase 2/Phase 3