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

NCT04953234 | Completed

• 1 other identifier: EF-37
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Frequency and severity of adverse events

  2 months

Secondary Outcomes (9)

• All-cause mortality

  Day 1 through Day 29

• Incidence of intensive care unit admission

  Day 1 through Day 29

• Incidence of non-invasive ventilation or high-flow oxygen use

  Day 1 through Day 29

• Incidence of invasive ventilation

  Day 1 through Day 29

• Incidence of extracorporeal membrane oxygenation

  Day 1 through Day 29

Study Arms (1)

NovoTTF-100L

EXPERIMENTAL

Patients receive TTFields using the NovoTTF-100L System together with COVID-19 best standard of care

Device: NovoTTF-100L

Interventions

NovoTTF-100L DEVICE

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.

Also known as: TTFields

NovoTTF-100L

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• NovoCure GmbH: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 7, 2021
• Study Start: February 23, 2021
• Primary Completion: April 26, 2021
• Study Completion: April 26, 2021
• Last Updated: July 7, 2021

Record last verified: 2021-07

Locations

IL (1)