Ignite Creation Date:
2024-05-06 @ 4:20 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04953234
Status:
COMPLETED
Last Update Posted:
2021-07-07
First Post:
2021-07-04
Brief Title:
Effect of Tumor Treating Fields TTFields 150 kHz Concomitant With Best Standard of Care for the Treatment of Hospitalized COVID-19 Patients and Continued Treatment Following Discharge
Sponsor:
NovoCure GmbH
Organization:
NovoCure Ltd
Study Overview
Official Title:
A Pilot Open-Label Study of NovoTTF-100L TTFields 150Hz in Hospitalized Patients With COVID-19 and Continued Treatment After Hospitalization
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
PAST PRE-CLINICAL AND CLINICAL EXPERIENCE
Tumor Treating Fields TTFields are a non-invasive regional antimitotic treatment modality with minimal toxicity which have been approved for the treatment of recurrent and newly diagnosed glioblastoma GBM by the Food and Drug Administration FDA in the United States and have obtained a CE mark in Europe for the same indications TTFields concomitant with chemotherapy were also approved for malignant pleural mesothelioma under FDAs humanitarian device exemption
Cell culture study demonstrated that TTFields can significantly reduce corona virus infection and replication in human lung cells
DESCRIPTION OF THE STUDY
All patients included in this study are patients who are hospitalized due to COVID-19 disease In addition all patients must meet all eligibility criteria
Eligible patients will be enrolled to the study and will receive COVID-19 best standard of care treatment concomitant with TTFields using the NovoTTF-100L System The patients will be treated continuously with the device until discharge from the hospital and until there are no limitations on activities
SCIENTIFIC BACKGROUND
Electric fields exert forces on electric charges similar to the way a magnet exerts forces on metallic particles within a magnetic field These forces cause movement and rotation of electrically charged biological building blocks much like the alignment of metallic particles seen along the lines of force radiating outwards from a magnet
Electric fields can also cause muscles to twitch and if strong enough may heat tissues TTFields are alternating electric fields of low intensity This means that they change their direction repetitively many times a second Since they change direction very rapidly 150 thousand times a second they do not cause muscles to twitch nor do they have any effects on other electrically activated tissues in the body brain nerves and heart Since the intensities of TTFields in the body are very low they do not cause heating
The breakthrough finding made by Novocure was that alternating fields of very low intensity now termed TTFields Tumor Treating Fields attenuate SARS-CoV-2 virus infection and replication TTFields can be directed to a certain part of the body leaving sensitive areas out of their reach
In conclusion TTFields hold the promise of serving as a brand new treatment for COVID-19 disease with very few side effects
Tumor Treating Fields TTFields are a non-invasive regional antimitotic treatment modality with minimal toxicity which have been approved for the treatment of recurrent and newly diagnosed glioblastoma GBM by the Food and Drug Administration FDA in the United States and have obtained a CE mark in Europe for the same indications TTFields concomitant with chemotherapy were also approved for malignant pleural mesothelioma under FDAs humanitarian device exemption
Cell culture study demonstrated that TTFields can significantly reduce corona virus infection and replication in human lung cells
DESCRIPTION OF THE STUDY
All patients included in this study are patients who are hospitalized due to COVID-19 disease In addition all patients must meet all eligibility criteria
Eligible patients will be enrolled to the study and will receive COVID-19 best standard of care treatment concomitant with TTFields using the NovoTTF-100L System The patients will be treated continuously with the device until discharge from the hospital and until there are no limitations on activities
SCIENTIFIC BACKGROUND
Electric fields exert forces on electric charges similar to the way a magnet exerts forces on metallic particles within a magnetic field These forces cause movement and rotation of electrically charged biological building blocks much like the alignment of metallic particles seen along the lines of force radiating outwards from a magnet
Electric fields can also cause muscles to twitch and if strong enough may heat tissues TTFields are alternating electric fields of low intensity This means that they change their direction repetitively many times a second Since they change direction very rapidly 150 thousand times a second they do not cause muscles to twitch nor do they have any effects on other electrically activated tissues in the body brain nerves and heart Since the intensities of TTFields in the body are very low they do not cause heating
The breakthrough finding made by Novocure was that alternating fields of very low intensity now termed TTFields Tumor Treating Fields attenuate SARS-CoV-2 virus infection and replication TTFields can be directed to a certain part of the body leaving sensitive areas out of their reach
In conclusion TTFields hold the promise of serving as a brand new treatment for COVID-19 disease with very few side effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None