Rectal Ozone in the COVID-19 treatment

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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:

ORC

Scientific title:

EXPLORATORY STUDY OF THE THERAPEUTIC EFFECT AND SAFETY OF RECTAL OZONE THERAPY IN PATIENTS POSITIVE TO SARS-CoV 2 WITH MILD TO MODERATE SYMPTOMS (COVID-19)

Acronym of Scientific Title:

ORC

Secondary indentifying numbers:

OZO-001

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), Ministry of Public Health (MINSAP)

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)

Authorization date :

04/06/2020

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 :

2nd degree specialist in Internal Medicine

Affiliation:

Dr. Salvador Allende Clinical Surgical Teaching Hospital

Postal address:

Calzada del Cerro No. 1551 esq. Dominguez. Cerro

City:

Havana

Country:

Cuba

Zip Code:

12000

Telephone:

+53-78776354

Email address:

sallende@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:

08/06/2020

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

Intervention(s):

Group 1 (Experimental): Treated with increasing dose of rectal ozone therapy (100 mL of gas with 30 μg / mL Ozone concentration every 12 hours x 1 day, 150 mg at 35 μg / mL every 12 hours the next day and 200 ml at 40 μg / mL c / 12 h the remaining 8 days + conventional therapy approved by the MINSAP integrated by Oseltamivir (75 mg c / 12 h orally x 14 days) or Kaletra (2 capsules c / 12h orally x 14 days) + Chloroquine ( 1 tab / 12h x 10 days) + Heberferon (3 million IU, IM route, three times a week x 3-4 weeks) Group 2 (Control): Treated with the MINSAP approved conventional therapy integrated by Oseltamivir (75 mg c / 12 hours orally x 14 days) or Kaletra (2 capsules every 12 hours orally x 14 days) + Chloroquine (1 tab every 12 hours x 10 days) + Heberferon (3 million IU, IM route, three times a week x 3-4 weeks)

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):

Real-time polymerase chain reaction test-TR-PCR (Positive/Negative). Measurement time: day 0, day 6, day 11 Clinical signs (fever, pain head, fatigue, sore throat, dry cough, dyspnea. Every signs evaluted like Yes/No). Measurement time: day 0 to day 11, day 15 Progression of clinical signs (equal, better, worse). Measurement time : day 0 to day 11, day 15

Key secondary outcomes:

C-reactive protein (values at mg/L). Measurement time: day 0, day 6, day 11 Serum ferritin (values at ug/L). Measurement time: day 0, day 6, day 11 Redox balance indicators (MDA (values at mmol/L). Total hydroperoxides (values at mmol/L). Nitric oxide (values at µmol/L). Glutathione (values at mmol/L). SOD (values at mmol/L). CAT (values at mmol/L)). Measurement time: day 0, day 6, day 11 Complete blood count (Hemoglobin (values at g/dL). Hematocrit (values at %). Red Blood Cells-Erythrocytes (values at x10^6/L), White Blood Cells-Leukocytes (values at x10^9/L), Plateles (values at x10^9/L), Lymphocytes (values at %), Monocytes (values at %), Eosinophils (values at %), Basophils (values at %), Neutrophils (values at %), Erythrocyte sedimentation (values at mm/h)). Measurement time: day 0, day 6, day 11 Blood chemistry (Albumin (values at g/L), LDH (values at U/L), ALT (values at U/L), AST (values at U/L), GGT (values at U/L), Creatinine (values at umol/L), Glucose (values at mmol/L), Bilirubin (values at mg/dl), Uric acid (values at mg/dl), Cholesterol (values at mmol/L), Triglycerides (values at mmol/L), HDL(values at mmol/L)). Measurement time: day 0, day 6, day 11

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 between 19 and 80 years, of either sex with a diagnosis confirmed by COVID-19 PCR-TR. 2- Patients who signed the informed consent to participate in the study. 3- Reported care patients with mild and moderate symptoms according to hospital diagnostic criteria (fever, dry cough and sore throat)

Exclusion criteria:

1- Pregnant or lactating patients. 2- Patients with uncontrolled hyperthyroidism. 3- Patients with glucose-6-phosphate dehydrogenase deficiency verified analytically or due to their medical history. 4- Chronic non-communicable diseases decompensated at the start of the trial. 5- Cancer patients due to being immunocompromised. 6- Patients with psychiatric illnesses that imply the 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 or active bleeding. 10- People with allergies or hypersensitivity to medical ozone. 11- Patients who participated in other clinical trials within the previous three months.

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:

N/A

Target sample size:

32

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

Middle Name:

Barbara

Last Name:

Zamora Rodriguez

Specialty:

Health Sciences PhD, pharmacologist

Affiliation:

National Center for Scientific Research (CNIC)

Postal Address:

Ave 25 y 198, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-53056529

Email :

zullyt.zamora@cnic.edu.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

Middle Name:

Barbara

Last Name:

Zamora Rodriguez

Specialty:

Health Sciences PhD, Pharmacologist

Affiliation:

National Center for Scientific Research (CNIC)

Postal Address:

Ave 25 y 198, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-53056529

Email :

zullyt.zamora@cnic.edu.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

Dr. Salvador Allende Clinical Surgical Teaching Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

01/06/2020

Postal address of Ethic Committee :

Calzada del Cerro No. 1551 esq. Dominguez. Cerro, Havana, 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:

23/08/2020

Date of available results:

23/08/2021

Date of first publication:

23/08/2021

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:

RPCEC00000320

Date of Registration in Primary Registry:

05/06/2020

Record Verification Date:

2020/06/05

Next update date:

2021/06/05

Link to the spanish version:

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Rectal Ozone in the COVID-19 treatment

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