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Rectal Ozone in the COVID-19 treatment
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5 Junio 2020 - 5:45pm
por Gladys
23 Marzo 2023 - 1:15am
por Gladys
Cambios a
Health condition(s) code
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Coronavirus Infections
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Coronaviridae Infections
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Nidovirales Infections
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SARS Virus
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Betacoronavirus
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Severe Acute Respiratory Syndrome
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Respiratory Tract Infections
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Respiration Disorders
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Respiratory Tract Diseases
Cambios a
Health condition keyword
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COVID-19
Cambios a
Intervention code
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Medicine, Traditional
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Oseltamivir
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Chloroquine
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Interferons
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Tablets
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Administration, Rectal
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Administration, Oral
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Injections, Intramuscular
Cambios a
Intervention keyword
-
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Ozone therapy,
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Kaletra,
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Heberferon
Cambios a
Record Verification Date
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2020/
06
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05
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2020/
09
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14
Cambios a
Next update date
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2021/
06
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05
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2021/
09
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14
Revisión de 23 Marzo 2023 - 1:15am
Rectal Ozone in the COVID-19 treatment
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)
Primary sponsor:
National Center for Scientific Research (CNIC)
Secondary sponsor:
Not applicable
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
País:
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
Health condition(s) code:
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
SARS Virus
Betacoronavirus
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Respiration Disorders
Respiratory Tract Diseases
Health condition keyword:
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)
Intervention code:
Medicine, Traditional
Oseltamivir
Chloroquine
Interferons
Tablets
Administration, Rectal
Administration, Oral
Injections, Intramuscular
Intervention keyword:
Ozone therapy, Kaletra, Heberferon
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
País:
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
País:
Cuba
Zip Code:
11300
Telephone:
+53-53056529
Email :
zullyt.zamora@cnic.edu.cu
Data Sharing
Section to complete the data related to the data sharing plan.
Data sharing plan:
No
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
Correo electrónico:
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:
2020/09/14
Next update date:
2021/09/14
Link to the spanish version:
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