Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms

Summary

The study is a prospective, randomized, controlled investigation designed for comparison of two groups for the reduction of respiratory distress in a CoViD-19 population, using gammaCore Sapphire (nVNS) plus standard of care (active) vs. standard of care alone (SoC), the control group. The gammaCore® (nVNS) treatments will be used acutely and prophylactically. The aims of this study are to summarize and compare the incidence of clinical events and pro-inflammatory cytokine levels in patients randomized to use of gammaCore Sapphire plus standard of care vs standard of care alone in patients hospitalized for CoViD-19. Secondary objectives are demonstrate the safety of gammaCore Sapphire use in patients hospitalized for CoViD-19.

Conditions

• COVID
• Corona Virus Infection
• Respiratory Failure
• Respiratory Distress Syndrome, Adult
• ARDS, Human
• SARS (Severe Acute Respiratory Syndrome)

Interventions

DEVICE

gammaCore® Sapphire (non-invasive vagus nerve stimulator)

Administer gammaCore® Sapphire daily, prophylactically, for three treatments (morning, mid-day and night, one hour before bed), each treatment consisting of two 2-minute doses/stimulations, one on each side of the neck. This would be a total of 6 treatments (2 doses x 3 times per day) of stimulation. For acute respiratory distress or shortness of breath (SOB), administer one treatment consisting of two 2-minute stimulations, on the neck. If respiratory distress or shortness of breath persists 20 minutes after the start of the first treatment, administer a second treatment.

OTHER

Standard of care therapies

Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms

Sponsors & Collaborators

• ElectroCore INC

  collaborator INDUSTRY

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

  lead OTHER

Principal Investigators

• Tariq Cheema, MD · Allegheny Health Network

• Boyle Cheng, PhD · Allegheny Health Network

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-05-15

Primary Completion

2022-08-22

Completion

2023-04-13

FDA Device

Yes

Countries

• United States

Study Locations