Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients

NCT04409886 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 120-20-ASF
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective randomized controlled, double blind clinical trial performed on laboratory confirmed COVID-19 infection admitted patients in the Shamir Medical Center. The trial will include 30 patients who will undergo either hyperbaric oxygen therapy (HBOT) or Normobaric oxygen therapy (NBOT), randomized on a 2:1 ratio, within 4 days in addition to the standard treatment including oxygen, drugs, steroids, bronchodilators, antibiotics and others. The evaluation procedure includes symptom monitoring, room air saturation, vital signs monitoring, pulmonary function and blood tests at baseline, one day and one week after the last session. In addition, one hour prior to and post session saturation and vitals will be monitored.

Conditions

COVID, Coronavirus

Outcome Measures

Primary Outcomes (1)

• Oxygenation Index

  PaO2/FiO2 (Oxygenation Index)

  one day after the last session

Study Arms (1)

HBOT (Hyperbaric Oxygen Therapy)

EXPERIMENTAL

Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)

Biological: Hyperbaric Oxygen Therapy

Interventions

Hyperbaric Oxygen Therapy BIOLOGICAL

Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)

HBOT (Hyperbaric Oxygen Therapy)

Eligibility Criteria

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

You may qualify if:

• Within 7 days of patient's need of oxygen supply
• Positive SARS-CoV-2 RT-PCR
• At least one risk factor for bad prognosis of COVID-19: hypertension, diabetes mellitus, ischemic heart disease, smoking, age\>50, etc.
• Respiratory insufficiency: Room Air SpO2 \<94% or PaO2/FiO2\<300mmHg
• Age\>18
• Ability to sign an informed consent

You may not qualify if:

• Negative SARS-CoV-2 RT-PCR
• HBOT contraindication: pneumothorax, pneumomediastinum, claustrophobia, ear/sinus disease which aren't allowed in HBOT, known chronic pulmonary disease: severe emphysema or known pulmonary bullae.
• Pregnancy
• Inability to sign an informed consent

Sponsors & Collaborators

• Maimonides Medical Center: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Results Point of Contact

• Title: Gene Sobol
• Organization: Maimonides Medical Center

gsobol@maimonidesmed.org

718-283-6000

Study Officials

• Ory Wiesel, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 1, 2020
• Study Start: June 1, 2020
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: June 29, 2021
• Results First Posted: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)