NCT04400006

Brief Summary

Coronavirus has already infected 4,673,809 people and killed 312,646 people worldwide, and no specific treatment or a vaccine against it has yet proven to be effective. Ozone therapy has become o promising tool for both prevention and treatment of COVID-19 infection by various possible mechanisms. The oxidative stress created by ozone in the body to stimulate the peripheral phagocytic cells, activate the antioxidant system, and restore the immune system is thought to be effective for the prevention of COVID-19 infection. In recent years, ozone therapy has become a popular alternative method for chronic pain management of various diseases such as fibromyalgia, knee osteoarthritis, and rheumatic diseases. As a result of this, there were many individuals who had received ozone therapy before the outbreak of COVID-19. This study aimed to investigate the preventive effect of ozone therapy against COVID-19 infection in these individuals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2020

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2020

Completed
Last Updated

May 22, 2020

Status Verified

May 1, 2020

Enrollment Period

10 days

First QC Date

May 21, 2020

Last Update Submit

May 21, 2020

Conditions

Keywords

CoronavirusOzonePreventive Medicine

Outcome Measures

Primary Outcomes (1)

  • The survey that was taken by telephone calls

    It involved questions about age, gender, height, weight, occupation, comorbidities, and concurrent medications, in addition to a detailed query for COVID-19 infection

    Day 0

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals who completed at least ten sessions of ozone therapy applied by the method of major autohemotherapy\* in the last six months from the time the first COVID-19 case of Turkey reported (Mar 11, 2020).

You may qualify if:

  • To be completed at least ten sessions of ozone therapy applied by the method of major autohemotherapy in the last six months from the time the first COVID-19 case of Turkey reported (Mar 11, 2020)

You may not qualify if:

  • To received ozone therapy locally or fewer than ten sessions
  • not want to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kardelen Gencer Atalay

Istanbul, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Kardelen Gencer

    Marmara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 21, 2020

First Posted

May 22, 2020

Study Start

May 6, 2020

Primary Completion

May 16, 2020

Study Completion

May 17, 2020

Last Updated

May 22, 2020

Record last verified: 2020-05

Locations