COVID-19 Clinical Trial
Official title:
A Pilot, Open-Label Study of NovoTTF-100L (TTFields, 150Hz) in Hospitalized Patients With COVID-19 and Continued Treatment After Hospitalization
NCT number | NCT04953234 |
Other study ID # | EF-37 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 23, 2021 |
Est. completion date | April 26, 2021 |
Verified date | July 2021 |
Source | NovoCure Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is a prospective, pilot study aimed to test the safety of Tumor Treating Fields (TTFields) concomitant with best standard of care, for the treatment of hospitalized COVID-19 patients and continued treatment after hospitalization. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields) to the region of the organ to be treated, by means of surface, insulated electrode arrays.
Status | Completed |
Enrollment | 10 |
Est. completion date | April 26, 2021 |
Est. primary completion date | April 26, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age = 18 years. 2. Hospitalized with diagnosis of COVID-19 infection per reverse transcription polymerase chain reaction (RT-PCR) within 72 hours prior to treatment start. 3. SpO2 = 93% at sea level. 4. Lung involvement confirmed with chest imaging. 5. Able and willing to comply with all study procedures. 6. Female participants of childbearing age must use highly effective contraception. 7. All patients must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted. Exclusion Criteria: 1. Receipt of any experimental treatment for COVID-19 prior to or during the study. 2. Assisted ventilation. 3. Critical illness: respiratory failure defined as oxygen saturation by pulse oximetry/inspired oxygen fraction (SpO2/FiO2) ratio < 150, septic shock, and/or multiple organ dysfunction. 4. Significant co-morbidities at baseline as determined by the investigator: 1. Clinically significant hematological, hepatic and renal dysfunction, defined as: Neutrophil count < 1.5 x 10^9/L and platelet count < 100 x 10^9/L; bilirubin > 1.5 x upper limit of normal (ULN); aspartate aminotransferase (AST) and/or alanine transaminase (ALT) > 2.5 x ULN; and serum creatinine > 2.5 mg/dL. 2. History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class IV (unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases). 3. History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the study. 4. History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent. 5. Implantable electronic medical devices (e.g. pacemaker, defibrillator) in the upper torso. 6. Pregnancy or breast-feeding. 7. Known allergies to medical adhesives or hydrogel. 8. Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's cooperation or other unspecified reasons that, in the opinion of the Investigator or sponsor, make the subject's enrollment incompatible with study objectives. |
Country | Name | City | State |
---|---|---|---|
Israel | Hadassah Medical Center | Jerusalem |
Lead Sponsor | Collaborator |
---|---|
NovoCure GmbH |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency and severity of adverse events | 2 months | ||
Secondary | All-cause mortality | The proportion of participants who died by study Day 29. | Day 1 through Day 29 | |
Secondary | Incidence of intensive care unit admission | Day 1 through Day 29 | ||
Secondary | Incidence of non-invasive ventilation or high-flow oxygen use | Day 1 through Day 29 | ||
Secondary | Incidence of invasive ventilation | Day 1 through Day 29 | ||
Secondary | Incidence of extracorporeal membrane oxygenation | Day 1 through Day 29 | ||
Secondary | Patient inflammatory status | Inflammatory status measured as the difference in C reactive protein (CRP), D-dimer and ferritin blood levels from baseline on days 3, 8 and 11 until discharge. | Day 3, 8, and 11 | |
Secondary | Duration of hospitalization | Day 1 through Day 29 | ||
Secondary | Time to recovery | Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities. | Day 1 through Day 29 | |
Secondary | Clinical status at day 8, 15, 22, 29 | Clinical status according to ordinal scale. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. | Day 8, 15, 22, and 29 |
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