COVID-19 PneumoniaNCT04444531
Ozone Therapy and Coronavirus Disease of 2019 (COVID-19) Pneumonia
An observational study of COVID-19 Pneumonia, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
Trial summary
The objective is to determine whether the use of ozone autohemotherapy is associated with a decrease in time to clinical improvement Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19 Pneumonia
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- 20 Mar 2020to 26 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
Study population: - Adults >18yo hospitalised patients confirmed COVID-19 infection (diagnosed by nasopharyngeal swab performed on admission), with severe pneumonia with baseline chest X-ray abnormalities + oxygen saturation <94% on room air, and tachypnea with respiratory rate exceeding 30 per minute.
Who may be able to join
- confirmed COVID-19 infection (diagnosed by nasopharyngeal swab performed on admission)
- severe pneumonia with baseline chest X-ray abnormalities;
- Oxygen saturation <94% on room air, and tachypnea with respiratory rate exceeding 30 per minute.
- Informed consent signed.
Who cannot join
- Not willing to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ozone Therapy for Patients With COVID-19 Pneumonia: Preliminary Report of a Prospective Case-control Study
The objective is to determine whether the use of ozone autohemotherapy is associated with a decrease in time to clinical improvement
- Conditions
- COVID-19 Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ozone autohemotherapy plus standard treatment | Not described | |
| Standard treatment alone | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical improvement
Clinical improvement was defined as a two-point reduction (relative to the patient's status on hospital admission) on a six-point ordinal scale, or discharge alive from the hospital, whichever came first. The six-point scale was as follows: death (6 points); extracorporeal membrane oxygenation or mechanical ventilation (5 points); noninvasive ventilation or high-flow oxygen therapy (4 points); oxygen therapy without need for high-flow oxygen or non-invasive ventilation (3 points); hospital admission without need for oxygen therapy (2 points); and discharged from hospital or reached discharge criteria (1 point). Discharge criteria were as evidence of clinical recovery (normalization of pyrexia, respiratory rate <24 per minute, oxygen saturation >94% on room air, and absence of cough) for at least 72 hours.
Measured: 28 days
Secondary outcomes (6)
Rate of patients with Clinical improvement at day 14
Clinical improvement was defined as a two-point reduction (relative to the patient's status on hospital admission) on a six-point ordinal scale, or discharge alive from the hospital, whichever came first. The six-point scale was as follows: death (6 points); extracorporeal membrane oxygenation or mechanical ventilation (5 points); noninvasive ventilation or high-flow oxygen therapy (4 points); oxygen therapy without need for high-flow oxygen or non-invasive ventilation (3 points); hospital admission without need for oxygen therapy (2 points); and discharged from hospital or reached discharge criteria (1 point). Discharge criteria were as evidence of clinical recovery (normalization of pyrexia, respiratory rate <24 per minute, oxygen saturation >94% on room air, and absence of cough) for at least 72 hours.
Measured: 14 days
Rate of patients with Clinical improvement at day 28
Clinical improvement was defined as a two-point reduction (relative to the patient's status on hospital admission) on a six-point ordinal scale, or discharge alive from the hospital, whichever came first. The six-point scale was as follows: death (6 points); extracorporeal membrane oxygenation or mechanical ventilation (5 points); noninvasive ventilation or high-flow oxygen therapy (4 points); oxygen therapy without need for high-flow oxygen or non-invasive ventilation (3 points); hospital admission without need for oxygen therapy (2 points); and discharged from hospital or reached discharge criteria (1 point). Discharge criteria were as evidence of clinical recovery (normalization of pyrexia, respiratory rate <24 per minute, oxygen saturation >94% on room air, and absence of cough) for at least 72 hours.
Measured: 28 days
Time to a 2-fold decrease of C-protein reactive from baseline
Measured: 28 days
Time to a 2-fold decrease of ferritin from baseline
Measured: 28 days
Time to a 2-fold decrease of Lactate Dehydrogenase from baseline
Measured: 28 days
Time to a 2-fold decrease of D-dimer from baseline
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start20 Mar 2020
- Primary completion19 May 2020
- Study completion26 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Vives, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444531
- Sponsor's protocol ID
- COVID Networking group
- Status last verified
- Nov 2020
- First submitted
- 22 Jun 2020
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Hernandez A, Vinals M, Pablos A, Vilas F, Papadakos PJ, Wijeysundera DN, Bergese SD, Vives M. Ozone therapy for patients with COVID-19 pneumonia: Preliminary report of a prospective case-control study. Int Immunopharmacol. 2021 Jan;90:107261. doi: 10.1016/j.intimp.2020.107261. Epub 2020 Dec 5.
PubMed 33310665
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ozone Therapy for Patients With COVID-19 Pneumonia: Preliminary Report of a Prospective Case-control Study
- ClinicalTrials.gov ID
- NCT04444531
- Acronym / sponsor ID
- COVID Networking group
- Conditions
- COVID-19 Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 19 May 2020 (actual)
- Study completion
- 26 May 2020 (actual)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to determine whether the use of ozone autohemotherapy is associated with a decrease in time to clinical improvement
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ozone autohemotherapy plus standard treatment | – | – |
| Standard treatment alone | – | – |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- - Adults >18yo hospitalised patients confirmed COVID-19 infection (diagnosed by nasopharyngeal swab performed on admission), with severe pneumonia with baseline chest X-ray abnormalities + oxygen saturation <94% on room air, and tachypnea with respiratory rate exceeding 30 per minute.
Key inclusion criteria (4 listed)
- confirmed COVID-19 infection (diagnosed by nasopharyngeal swab performed on admission)
- severe pneumonia with baseline chest X-ray abnormalities;
- Oxygen saturation <94% on room air, and tachypnea with respiratory rate exceeding 30 per minute.
- Informed consent signed.
Key exclusion criteria (1 listed)
- Not willing to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to clinical improvement
Time frame: 28 days
Clinical improvement was defined as a two-point reduction (relative to the patient's status on hospital admission) on a six-point ordinal scale, or discharge alive from the hospital, whichever came first. The six-point scale was as follows: death (6 points); extracorporeal membrane oxygenation or mechanical ventilation (5 points); noninvasive ventilation or high-flow oxygen therapy (4 points); oxygen therapy without need for high-flow oxygen or non-invasive ventilation (3 points); hospital admission without need for oxygen therapy (2 points); and discharged from hospital or reached discharge criteria (1 point). Discharge criteria were as evidence of clinical recovery (normalization of pyrexia, respiratory rate <24 per minute, oxygen saturation >94% on room air, and absence of cough) for at least 72 hours.
6 secondary outcomes
Rate of patients with Clinical improvement at day 14
Time frame: 14 days
Rate of patients with Clinical improvement at day 28
Time frame: 28 days
Time to a 2-fold decrease of C-protein reactive from baseline
Time frame: 28 days
Time to a 2-fold decrease of ferritin from baseline
Time frame: 28 days
Time to a 2-fold decrease of Lactate Dehydrogenase from baseline
Time frame: 28 days
Time to a 2-fold decrease of D-dimer from baseline
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Derived from this study: PubMed 33310665Hernandez A, Vinals M, Pablos A, Vilas F, Papadakos PJ, Wijeysundera DN, Bergese SD, Vives M. Ozone therapy for patients with COVID-19 pneumonia: Preliminary report of a prospective case-control study. Int Immunopharmacol. 2021 Jan;90:107261. doi: 10.1016/j.intimp.2020.107261. Epub 2020 Dec 5.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pneumonia, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to clinical improvement (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04444531, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2020.