COVID-19NCT04953234
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
A study testing NovoTTF-100L in people with COVID-19, run by NovoCure GmbH at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- NovoTTF-100L
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 23 Feb 2021to 26 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Hospitalized with diagnosis of COVID-19 infection per reverse transcription polymerase chain reaction (RT-PCR) within 72 hours prior to treatment start.
- SpO2 ≤ 93% at sea level.
- Lung involvement confirmed with chest imaging.
- Able and willing to comply with all study procedures.
- Female participants of childbearing age must use highly effective contraception.
- All patients must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
Who cannot join
- Receipt of any experimental treatment for COVID-19 prior to or during the study.
- Assisted ventilation.
- 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.
- Significant co-morbidities at baseline as determined by the investigator:
- 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.
- 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).
Show all 12Show fewer
- 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.
- 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.
- Implantable electronic medical devices (e.g. pacemaker, defibrillator) in the upper torso.
- Pregnancy or breast-feeding.
- Known allergies to medical adhesives or hydrogel.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot, Open-Label Study of NovoTTF-100L (TTFields, 150Hz) in Hospitalized Patients With COVID-19 and Continued Treatment After Hospitalization
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.
Read the 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 FDA's 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.
- Conditions
- COVID-19
- Being tested
- NovoTTF-100L
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovoTTF-100LDevice
Also called TTFields
Patients receive continuous TTFields treatment using the NovoTTF-100L device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the thorax. The treatment enables the patient to maintain regular daily routine.
| Study group | Role | What they receive |
|---|---|---|
| NovoTTF-100L | Experimental | Patients receive TTFields using the NovoTTF-100L System together with COVID-19 best standard of care Receives: Device: NovoTTF-100L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of adverse events
Measured: 2 months
Secondary outcomes (9)
All-cause mortality
The proportion of participants who died by study Day 29.
Measured: Day 1 through Day 29
Incidence of intensive care unit admission
Measured: Day 1 through Day 29
Incidence of non-invasive ventilation or high-flow oxygen use
Measured: Day 1 through Day 29
Incidence of invasive ventilation
Measured: Day 1 through Day 29
Incidence of extracorporeal membrane oxygenation
Measured: Day 1 through Day 29
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.
Measured: Day 3, 8, and 11
Duration of hospitalization
Measured: Day 1 through Day 29
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.
Measured: Day 1 through Day 29
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.
Measured: Day 8, 15, 22, and 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start23 Feb 2021
- Primary completion26 Apr 2021
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoCure GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953234
- Sponsor's protocol ID
- EF-37
- Status last verified
- Jul 2021
- First submitted
- 4 Jul 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Open-Label Study of NovoTTF-100L (TTFields, 150Hz) in Hospitalized Patients With COVID-19 and Continued Treatment After Hospitalization
- ClinicalTrials.gov ID
- NCT04953234
- Acronym / sponsor ID
- EF-37
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NovoCure GmbHIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 7 Jul 2021 (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.
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 FDA's 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NovoTTF-100L | Experimental | Device: NovoTTF-100LPatients receive TTFields using the NovoTTF-100L System together with COVID-19 best standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years.
- Hospitalized with diagnosis of COVID-19 infection per reverse transcription polymerase chain reaction (RT-PCR) within 72 hours prior to treatment start.
- SpO2 ≤ 93% at sea level.
- Lung involvement confirmed with chest imaging.
- Able and willing to comply with all study procedures.
Key exclusion criteria (12 listed)
- Receipt of any experimental treatment for COVID-19 prior to or during the study.
- Assisted ventilation.
- 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.
- Significant co-morbidities at baseline as determined by the investigator:
- Implantable electronic medical devices (e.g. pacemaker, defibrillator) in the upper torso.
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 |
|---|---|---|
| NovoTTF-100LAlso: TTFieldsPatients receive continuous TTFields treatment using the NovoTTF-100L device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the thorax. The treatment enables the patient to maintain regular daily routine. | Device | NovoTTF-100L |
Primary outcome
Frequency and severity of adverse events
Time frame: 2 months
9 secondary outcomes
All-cause mortality
Time frame: Day 1 through Day 29
Incidence of intensive care unit admission
Time frame: Day 1 through Day 29
Incidence of non-invasive ventilation or high-flow oxygen use
Time frame: Day 1 through Day 29
Incidence of invasive ventilation
Time frame: Day 1 through Day 29
Incidence of extracorporeal membrane oxygenation
Time frame: Day 1 through Day 29
Patient inflammatory status
Time frame: Day 3, 8, and 11
Duration of hospitalization
Time frame: Day 1 through Day 29
Time to recovery
Time frame: Day 1 through Day 29
Clinical status at day 8, 15, 22, 29
Time frame: Day 8, 15, 22, and 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Individual participant dataSharing planned: Undecided
Related trials for COVID-19
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Not yet recruitingPhase 3
Dapagliflozin for Long COVID Syndrome
COVID - 19, Long COVID Syndrome
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
Active, not recruitingObservational study
Analysis of Coronavirus Disease 19 (COVID-19) Convalescent Plasma
Asymptomatic COVID-19 Infection Laboratory-Confirmed, Symptomatic COVID-19 Infection Laboratory-Confirmed
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
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. This study is not recruiting at the moment.
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 study testing NovoTTF-100L in people with COVID-19, run by NovoCure GmbH at 1 site in Israel.
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 7 inclusion and 12 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: finished, as of the sponsor's last update on 7 Jul 2021. 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 Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency and severity of adverse events (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2021.