COVID-19 Clinical Trial
Official title:
A Pilot Study of Ruxolitinib to Combat COVID-19
Verified date | May 2020 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators hypothesize that JAK 1/2 inhibition with ruxolitinib, an FDA approved treatment for intermediate or high-risk myelofibrosis, could have a similar effect in patients with severe COVID-19, quelling the immune-hyperactivation, allowing for clearance of the virus and reversal of the disease manifestations.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 31, 2021 |
Est. primary completion date | July 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - A diagnosis of advanced COVID-19 as defined by both of the following: - A positive test for SARS-CoV-2 RNA detected by RT-PCR collected from the upper respiratory tract (nasopharyngeal and oropharyngeal swab) and, if possible, the lower respiratory tract (sputum, tracheal aspirate, or bronchoalveolar lavage), analyzed by a CLIA certified lab - Critical disease manifested by any of the following: - Chest imaging (CT or chest X-ray permitted) with = 50% lung involvement - Respiratory failure requiring invasive mechanical ventilation or supplementary oxygen with FiO2 = 50% - Shock (defined as mean arterial pressure = 65 mmHg unresponsive to 25ml/kg isotonic intravenous fluid resuscitation and/or requiring vasopressor support - Cardiac dysfunction defined by: - New global systolic dysfunction with ejection fraction = 40% - Takotsubo cardiomyopathy - New onset supraventricular or ventricular arrhythmias - Plasma troponin I = 0.10 ng/mL in someone without previously documented troponin elevation beyond that level - Elevated plasma NT-proBNP in someone without documented prior elevation - If Age < 50, NT-proBNP > 450 pg/ml - If Age 50-74, NT-proBNP > 900 pg/ml - If Age = 74, NT-proBNP > 1800 pg/ml - Receipt of investigational or off-label agents for COVID-19 (prior or ongoing) does not exclude eligibility. - Patients who have received autologous or allogeneic stem cell transplant are eligible at the discretion of the investigators. - 18 years of age or older at the time of study registration - Adequate hematologic function defined as: - absolute neutrophil count = 1000/mm3 - platelet count = 50,000/mm3 without growth factor or transfusion support for 7 days prior to screening - Creatinine clearance = 15 mL/minute or receiving renal replacement therapy - Women of childbearing potential (defined as women with regular menses, women with amenorrhea, women with irregular cycles, women using a contraceptive method that precludes withdrawal bleeding, or women who have had a tubal ligation) are required to have a negative pregnancy test and use two forms of acceptable contraception, including one barrier method, during participation in the study treatment period. - Male patients (if engaging in reproductive sex with a women of childbearing potential) are required to use two forms of acceptable contraception, including one barrier method, during participation in the study and throughout the evaluation period. - Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable) Exclusion Criteria: - Known allergy or intolerance to ruxolitinib or another JAK inhibitor. - Known or suspected active viral (including HIV, hepatitis B, and hepatitis C), bacterial, mycobacterial, or fungal infection other than COVID-19. Virologic testing not required unless infection is suspected. - Pregnant and/or breastfeeding. - Any uncontrolled intercurrent illness that would put the patient at greater risk or limit compliance with study requirements in the opinion of the investigator. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | Incyte Corporation |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | Through 28 days | ||
Secondary | Length of hospital stay | Through completion of follow-up (estimated to be 7 months) | ||
Secondary | Length of ICU stay | Through completion of follow-up (estimated to be 7 months) | ||
Secondary | Duration of ventilator use | Through completion of follow-up (estimated to be 7 months) | ||
Secondary | Duration of vasopressors use | Through completion of follow-up (estimated to be 7 months) | ||
Secondary | Duration on renal replacement therapy | Through completion of follow-up (estimated to be 7 months) | ||
Secondary | Viral kinetics as measured by virologic failure | -Defined as increase in viral load of >0.5 log on two consecutive days, or >1 log increase in one day, not in keeping with any baseline trend of rising viral loads during the pre-treatment viral testing | Through completion of follow-up (estimated to be 7 months) | |
Secondary | Number of adverse events as measured by CTCAE v. 5.0 | Through completion of follow-up (estimated to be 7 months) | ||
Secondary | Proportion of participants with detectable virus | Day 5 | ||
Secondary | Proportion of participants with detectable virus | Day 10 | ||
Secondary | Proportion of participants with detectable virus | Day 15 | ||
Secondary | Proportion of participants with detectable virus | Day 29 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT06065033 -
Exercise Interventions in Post-acute Sequelae of Covid-19
|
N/A | |
Completed |
NCT06267534 -
Mindfulness-based Mobile Applications Program
|
N/A | |
Completed |
NCT05047601 -
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
|
Phase 2/Phase 3 | |
Recruiting |
NCT04481633 -
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
|
N/A | |
Recruiting |
NCT05323760 -
Functional Capacity in Patients Post Mild COVID-19
|
N/A | |
Completed |
NCT04537949 -
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
|
Phase 1/Phase 2 | |
Completed |
NCT04612972 -
Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru
|
Phase 3 | |
Recruiting |
NCT05494424 -
Cognitive Rehabilitation in Post-COVID-19 Condition
|
N/A | |
Active, not recruiting |
NCT06039449 -
A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2
|
Phase 3 | |
Enrolling by invitation |
NCT05589376 -
You and Me Healthy
|
||
Completed |
NCT05158816 -
Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
|
||
Recruiting |
NCT04341506 -
Non-contact ECG Sensor System for COVID19
|
||
Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
Completed |
NCT04512079 -
FREEDOM COVID-19 Anticoagulation Strategy
|
Phase 4 | |
Completed |
NCT05975060 -
A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT05542862 -
Booster Study of SpikoGen COVID-19 Vaccine
|
Phase 3 | |
Terminated |
NCT05487040 -
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
|
Phase 1 | |
Withdrawn |
NCT05621967 -
Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
|
N/A | |
Terminated |
NCT04498273 -
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
|
Phase 3 | |
Active, not recruiting |
NCT06033560 -
The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure
|