To Observe Whether Isoflurane Can Treat COVID-19 Patients

NCT04492943 | Completed

• 1 other identifier: 2020P001048
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This is a blood collection and retrospective data collection study. The investigators plan to assess whether the sedative drug, isoflurane, can treat COVID-19 patients relatively better compared to other sedative drugs given during routine treatment to patients on mechanical ventilation. The investigators will also use nanoneedle biosensors to quickly detect blood IgM/IgG ratio in those patients, and (3) to establish a pre-clinical system to determine the effects of inhalational anesthetics on amounts of SARS-CoV-2 and other viruses, and pneumoniae.

Conditions

COVID-19

Keywords

Mechanical ventilation; Anesthesia

Outcome Measures

Primary Outcomes (3)

• Survival Outcome

  Survival outcome will be based on whether the patient either (a) recovers from COVID-19 and is discharged from the hospital or (b) does not recover from COVID-19 and passes away while in the hospital.

  From the date of hospital admission until date of discharge or death of any cause, assessed up to 6 months.

• COVID-19 Testing Methods

  Identifying faster COVID-19 testing methods, specifically nanoneedle biotechnology.

  From the date of hospital admission until date of discharge or death of any cause, assessed up to 6 months.

• COVID-19 Clearance

  COVID-19 clearance will be based on whether the patient either (a) tests negative for COVID-19 after treatment in the hospital or (b) does not test negative for COVID-19 after treatment in the hospital.

  From the date of hospital admission until date of discharge or death of any cause, assessed up to 6 months.

Eligibility Criteria

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

Study Population

COVID-19 positive patients placed on mechanical ventilation

You may qualify if:

• Over the age of 18 years old
• Tested positive for COVID-19
• Documented SARS-CoV-2 carriage in the nasopharyngeal sample by PCR
• Intubated for mechanical ventilation with an anesthesia machine

You may not qualify if:

• Patient or any their family members have any contraindication for inhalation anesthetics (e.g., malignant hyperthermia).

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02129-2020, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood may be collected from patients if available from excess clinical blood draws conducted during routine clinical care.

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: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: July 30, 2020
• Study Start: April 20, 2020
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-09

Locations

US (1)