Rectal ozone therapy in high-risk symptomatic SARS-CoV-2 positive patients

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

OZO-002

Scientific title:

Therapeutic effect of rectal ozone therapy in high-risk symptomatic SARS-CoV-2 positive patients under intensive surveillance. Phase III clinical trial. (COVID-19)

Acronym of Scientific Title:

OZO-COVID-002

Secondary indentifying numbers:

OZO-002/2021

Issuing authority of the secondary identifying numbers:

National Center for Scientific Research (CNIC)

Source(s) of monetary or material support:

National Center for Scientific Research, Central Account for BioCubafarma

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Rodolfo

Last name:

Suarez Iznaga

Medical Specialty :

Second Degree Specialist in Internal Medicine

Affiliation:

Salvador Allende Hospital

Postal address:

Calzada Cerro No. 1551, Cerro

City:

Havana

Country:

Cuba

Zip Code:

12000

Telephone:

+53-52504597

Email address:

rodolfo.suarez@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

01/09/2021

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

COVID-19

Health condition(s) code:

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

SARS Virus

Betacoronavirus

Health condition keyword:

COVID-19

SARS-CoV2

Intervention(s):

Group 1 Ozone (experimental). Rectal ozone therapy + Cuban national action protocol for Covid-19. Version 1.6.. Ozone therapy: It will be applied by rectal insufflation according to the following scheme Day 1: 100 mL of gas with 30 μg / mL of Ozone concentration, (3 mg of ozone) every 12 hours Day 2: 150 mL of gas with 35 μg / mL of Ozone concentration, (5.25 mg of ozone) every 12 hours Day 3-10: 200 mL of gas with 40 μg / mL of Ozone concentration, (8 mg of ozone) every 12 hours. The treatment will finish with 20 sessions of rectal ozone therapy for 10 days. Cuban national action protocol for Covid-19. Version 1.6: Heberferόn ® Interferon α-2b recombinant + Interferon gamma recombinant, according to the national form 3, 5 M IU, by intramuscular route, every three days, it is administered one day, two days are waited and it is applied again. Kaletra: 2 tablets every 12 hours, for 10 days. Chloroquine 1 tablet every 12 hours, for 10 days. Broad spectrum antibiotics if you suspect bacterial over-infection (Ceftriaxone 1gr to 2gr every 12 hours: in patients where associated bacterial infection is diagnosed. The decision to use another antibiotic will be determined by the results of laboratory studies and the microbiological map of the service). Treatment of comorbidities, according to their compensation status. Group 2 Conventional therapy (Control). Cuban national action protocol for Covid-19. Version 1.6. This therapy is compound by: Heberferόn ® Interferon α-2b recombinant + Interferon gamma recombinant, according to the national form 3, 5 M IU, by intramuscular route, every three days, it is administered one day, two days are waited and it is applied again. Kaletra: 2 tablets every 12 hours, for 10 days. Chloroquine 1 tablet every 12 hours, for 10 days. Broad spectrum antibiotics if you suspect bacterial over-infection (Ceftriaxone 1gr to 2gr every 12 hours: in patients where associated bacterial infection is diagnosed. The decision to use another antibiotic will be determined by the results of laboratory studies and the microbiological map of the service). Treatment of comorbidities, according to their compensation status.

Intervention code:

Interferon-alpha

Interferon-gamma

Interferons

Anti-Bacterial Agents

Anti-Infective Agents

Tablets

Ceftriaxone

Chloroquine

Administration, Rectal

Injections, Intramuscular

Administration, Oral

Insufflation

Intervention keyword:

Kaletra, Ozonetherapy

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

1- RT-PCR (Negativization of the test) (Positive or negative). Measurement time: Baseline, on the 5th, 7th and 10th days of treatment. 2- Clinical signs (mild, moderate, severe, critical). Measurement time: Every day until finalizing the treatment. Will be classified as: Mild: Fever, cough, sore throat, nasal congestion, slight headache, general malaise, diarrhea and / or vomiting. Normal radiology. Oxygen saturation greater than 95%. Moderate: Fever, cough, polypnea, slight changes in the Rx or lung ultrasound. Oxygen saturation greater than or equal to 90%. Severe: Fever, cough, polypnea, infiltrate / condensation Rx or lung ultrasound. Oxygen saturation less than 90% or requires VAM. Critical: ARDS, Sepsis or Septic Shock. 3- Evolution of the symptom (the same, better or worse). Measurement time: Every day until finalizing the treatment. 4- Dyspnea (dysnea scale using the BORG method). Measurement time: Every day until finalizing the treatment. 5- Oximetry (determination by digital oximetro). Measurement time: Every day until finalizing the treatment.

Key secondary outcomes:

1- C-reactive protein (mg/L). Measurement time: at Baseline, on the 5th, 7th and 10th days of treatment. 2- Dimero-D (ng/mL). Measurement time: at Baseline, on the 5th, 7th and 10th days of treatment. 3- Serum ferritin (ng/ml). Measurement time: at Baseline, on the 5th, 7th and 10th days of treatment. 4- Redox Balance Indicator: Malondialdehyde (mmol/mgHb), PAOP (mM/cloramina T), Nitric Oxide (uM); Glutathione (mM/mgHb), dismutase superoxide (U/mhHb min) and catalase (U/mgHb min). Measurement time: at Baseline, on the 5th, 7th and 10th days of treatment. 5- Hemogram: hemoglobin (g/L), hematocrit (%), red blood cells (erythrocytes) (x106/L), white blood cells (leukocytes) (x106/L), platelets (x109/L)and mean platelet volume (ft) and differential of leukocytes (lymphocytes (%), monocytes (%), basophils (%), eosinophils (%) and neutrophils (%), erythrocyte sedimentation (mm/h). Measurement time: Baseline, on the 5th, 7th and 10th days of treatment. 6- Blood biochemical: Lactate dehydrogenase (U/L), alanine amino transferase (U/L), aspartate amino transferase (U/L), creatinine kinase (mmol/L), gamma-glutamyl transferase (U/L), glucose (mmol/L), creatinine (umol/L), biliribine (umol/L), uric acid (mg/dL). Measurement time: Baseline, on the 5th, 7th and 10th days of treatment. 7- Chest X-ray (an evaluation scale will be classify inflammatory lung damage. Measuremetn time: Baseline and progressively according to the criteria of the attending physician. 8- Intestinal microbiota (positive or negative). Measurement time: Baseline, on the 5th and 10th days of treatment.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

80 years

Inclusion criteria:

1) Hospitalized patients 2) between 19 and 80 years of age, 3) of both sexes 4) with a confirmed diagnosis of COVID-19 by TR-PCR. 5) That they have signed the informed consent to participate in the study. 6) Reported care patients with high risk mild and moderate symptoms according to hospital diagnostic criteria. High-risk patient (RA): patient 65 years of age or older, with or without comorbidities, and patient under 65 years of age with comorbidities.

Exclusion criteria:

1) Pregnant or lactating patients. 2) Patients with glucose-6-phosphate-dehydrogenase deficiency proven analytically or by their medical history. 3) Chronic non-communicable diseases decompensated at the time of initiation of the trial 4) Cancer patients for being immunocompromised. 5) Patients with uncontrolled hyperthyroidism. 6) Patients with psychiatric illnesses, mental retardation or cognitive impairment that imply the psychological incompetence of the subject. 7) Scheduled surgery or other procedures that require general anesthesia during the study. 8) Patients who use immunosuppressants continuously, or who undergo an organ transplant within 6 months. 9) Patients with bleeding disorders, thrombocytopenia, active bleeding or who are under anticoagulant treatment. 10) Patients who participated in other clinical trials within the previous three months (eg. Vaccination with COVID 19 candidates) 11) Patients who were previously ill with COVID 19 12) People with allergies or hypersensitivity to medical ozone. 13) Patients with motor disabilities that make it difficult or impossible for them to move autonomously 14) Patients with more than two diarrhea a day.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

3

Target sample size:

292

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Rodolfo

Last Name:

Suarez Iznaga

Specialty:

Second Degree Specialist in Internal Medicine

Affiliation:

Salvador Allende Hospital

Postal Address:

Calzada del Cerro No. 1551, Cerro

City:

Havana

Country:

Cuba

Zip Code:

12000

Telephone:

+53-52504597

Email :

rodolfo.suarez@infomed.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Zullyt

Last Name:

Zamora Rodriguez

Specialty:

PhD in Health Sciences

Affiliation:

National Center for Scientific Research

Postal Address:

Ave 25 y 158, Cuabanaca, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-53056529

Email :

zullyt.zamora@cnic.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Salvador Allende Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

22/04/2021

Postal address of Ethic Committee :

Calzada del Cerro 1551, Cerro, Havana, ZC 12000, Cuba

Telephone:

+53-78776354

Email:

sallende@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

11/11/2021

Date of available results:

11/01/2022

Date of first publication:

11/03/2022

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000383

Date of Registration in Primary Registry:

15/07/2021

Record Verification Date:

2021/07/15

Next update date:

2022/07/15

Link to the spanish version:

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Rectal ozone therapy in high-risk symptomatic SARS-CoV-2 positive patients

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