Prevalence of positive evolutive PCR in patients with COVID 19 treated with rectal ozone therapy: observational study prospective cohort.

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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-EST-OBS

Scientific title:

Prevalence of positive evolutive PCR in patients with COVID 19 treated with rectal ozone therapy: observational study prospective cohort. (COVID-19)

Acronym of Scientific Title:

OZONOTHERAPY-STUDY-OBSERVACIONAL

Secondary indentifying numbers:

OZO-EST-OBS-01

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 (CNIC), 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:

Others instances

Other regulatory instances:

Cuban Public Health Ministry

Authorization date :

12/08/2020

Reference number:

Not applicable

Principal investigator

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

First name:

Zullyt

Last name:

Zamora Rodriguez

Medical Specialty :

Doctor of Health Sciences

Affiliation:

National Center for Scientific Research (CNIC)

Postal address:

Ave 25 y 158, Reparto Cubanacan, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72724841

Email address:

zullyt.zamora@cnic.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:

Havana, "Dr. Salvador Allende" Clinical-Surgical Hospital

Havana, "Dr. Luis Diaz Soto" Hospital

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

15/08/2020

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

SARS Virus

Coronaviridae Infections

Nidovirales Infections

Betacoronavirus

Disease Prevention

Health condition keyword:

COVID-19

SARS-CoV2

Intervention(s):

Rectal Ozonotherapy every 12 hours during 10 days (150 mL gas WITH 40 μg/mL Ozono concentration (8 mg Ozono) )

Intervention code:

Medicine, Traditional

Administration, Rectal

Intervention keyword:

Ozone therapy

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. Virology- PCR SARS CoV 2 (Positive, Negative). Measurement time: Baseline and at day 10 2. Clinical signs (Fever (Yes, No), Cephalea (Yes, No), Fatigue (Yes, No), Sore throat (Yes, No), Cough dehydrates (Yes, No), Others (Yes, No )). Measurement time: Baseline and at day 10 3. Hematology (Hemoglobin, hematocrit, erythrocytes, leukocytes with differential, Erythrosedimentation, using numerical values according to the units of the clinical sites). Measurement time: Baseline and at day 10 4. Biochemical (ALT, AST, GGT, Glucose, creatinine, albumin, uric acid, using numerical values according to the units of the clinical sites) Measurement time: Baseline and at day 10.

Key secondary outcomes:

Adverse Events-AE (Name of AE, Intensity ((mild, moderate and severe), possible relation with the treatment (definitivamen related, probably related, possible, no related)). Measurement time: daily during 10 days.

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:

Hospitalization patients between 19-80 years old, both sexes, persistent positive to SARS-CoV 2. To receive ozone therapy, the patient's must have given their consent

Exclusion criteria:

1. Patients with uncontrolled hyperthyroidism 2. Patients with deficit glucose-6-fosfato-deshidrogenasa comprobate or by ancedent of clinic history. 3. 3. Chronic non-transmisible diseases decompensated at the beginning of the trial 4. Oncological patients because they are immunocompromised. 5. Patients with psiquiatric problems that imply the incompetence of the subject. 6. Surgery or other procedures that require general anesthesia during the study. 7. Patients use inmunosupresores or organs trasplants in previos 6 months. 8. Patients with coagulations trastorn, thrombocytopenia or active bleeding. 9. Patients with allergies or hypersensitivity to medical ozone. 10. Patients incorporated in another clinical trial.

Type of population:

Adults

Type of participant:

Patients

Study design

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

Type study:

Observational

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

N/A

Target sample size:

200

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:

Zullyt

Last Name:

Zamora Rodriguez

Specialty:

PhD in Health Science

Affiliation:

National Center for Scientific Research

Postal Address:

Ave 25 y 158, Reparto Cubanacan, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72724841

Email :

zullyt.zamora@cnic.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:

Zully

Last Name:

Zamora Rodríguez

Specialty:

PhD in Health Science

Affiliation:

National center for Scientific Research

Postal Address:

11300

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72724841

Email :

zullyt.zamora@cnic.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

200

Study completion date:

25/10/2020

Date of available results:

01/12/2020

Date of first publication:

15/01/2021

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:

RPCEC00000341

Date of Registration in Primary Registry:

27/10/2020

Record Verification Date:

2020/10/27

Next update date:

2021/10/27

Link to the spanish version:

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Prevalence of positive evolutive PCR in patients with COVID 19 treated with rectal ozone therapy: observational study prospective cohort.

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