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NCT04370223: COVID-OZONE

Ozone Auto-hemotherapy for COVID-19 Pneumonia

Status unknown Phase 3 Last updated 9 June 2020
What this trial tests

Phase 3 trial testing Ozone auto-hemotherapy in COVID-19 Pneumonia in 208 participants. Status unknown.

Timeline
25 May 2020
Primary endpoint
25 October 2020
25 December 2020

Quick facts

Lead sponsorInstitut d'Investigació Biomèdica de Girona Dr. Josep Trueta
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment208
Start date25 May 2020
Primary completion25 October 2020
Estimated completion25 December 2020
Sites10 locations across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Who can join

Adults 18 to 90, any sex, with COVID-19 Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, randomized, controlled, open-label clinical trial testing the use of ozone auto-hemotherapy in hospitalized patients with Covid-19 pneumonia. Eligible patients will be randomly assigned to receive either ozone auto-hemotherapy plus standard treatment, or standard treatment alone. Patients in the ozone auto-hemotherapy group will receive treatment mixing 100-200ml of blood with ozone at a concentration of 40 μg / mL with a gas volume of 200 ml. Treatment will occur every 12h during 5 days. Standard treatment will be the one used in each hospital participating in the trial. All analyses will be done according to the intention-to-treat principle

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
    Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
  2. Multi-omics-based identification of SARS-CoV-2 infection biology and candidate drugs against COVID-19.
    Barh D, Tiwari S, Weener ME, Azevedo V, et al · · 2020 · cited 57× · PMID 33131530 · DOI 10.1016/j.compbiomed.2020.104051
  3. Insights on the mechanisms of action of ozone in the medical therapy against COVID-19.
    Chirumbolo S, Valdenassi L, Simonetti V, Bertossi D, et al · · 2021 · cited 29× · PMID 34020394 · DOI 10.1016/j.intimp.2021.107777
  4. The Relationship between Ozone and Human Blood in the Course of a Well-Controlled, Mild, and Transitory Oxidative Eustress.
    Tricarico G, Travagli V. · · 2021 · cited 22× · PMID 34943049 · DOI 10.3390/antiox10121946
  5. Rationale for ozone-therapy as an adjuvant therapy in COVID-19: a narrative review.
    Ranaldi GT, Villani ER, Franza L. · · 2020 · cited 7× · PMID 33004712 · DOI 10.4103/2045-9912.289462

Verify or expand the search:

Other recruiting trials for COVID-19 Pneumonia

Currently open trials in the same condition.

Other Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta trials

Trials by the same sponsor.

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