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RIC as an Adjunct Therapy for Severe COVID-19 Disease: a Prospective Randomized Pilot Study

NCT04659460 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-12-09

No results posted yet for this study

Summary

This research aims to assess the use of an experimental and non-invasive procedure, Remote Ischemic Conditioning (RIC), as an adjunct therapy in attenuating severe COVID-19 disease. An excessive and counterproductive systemic inflammatory response is thought to be a major cause of severe disease and death in patients with COVID-19. Severe ICU cases frequently have markedly higher levels of inflammatory markers such as CRP, IL-6, IL and TNF-a; which is thought to be correlated with increasing disease severity. The relationship between dysregulated inflammatory processes and disease states such as acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are well understood. ALI is characterized by an acute exaggerated mononuclear/neutrophilic inflammatory response followed by progressive collagen deposition in the lung, and if severe enough, may progress to ARDS requiring ventilation.

Conditions

  • COVID
  • Corona Virus Infection
  • Acute Lung Injury
  • Ischemia Limb
  • Acute Respiratory Distress Syndrome

Interventions

DEVICE

Remote Ischemic Conditioning

RIC interventions will be applied to the upper extremity calibrated to induce four, ten-minute cycles of five-minutes-ischemia and five-minutes-perfusion for a total of 20 cumulative minutes of limb ischemia, at a pressure of 250 mmHg.

Sponsors & Collaborators

  • Defence Research and Development Canada

    collaborator INDUSTRY

  • Unity Health Toronto

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-15
Primary Completion
2021-03-31
Completion
2021-09-01

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04659460 on ClinicalTrials.gov