Observational study of the benefits of rectal ozonotherapy and BIOPLA as complemetary theraphy in convalescent patients with SARS-COV 2

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-BIOPLA-SARS-COV 2

Scientific title:

Observational study of the benefits of rectal ozonotherapy and BIOPLA as complementary therapy in convalescent patients with SARS-COV 2 (COVID-19)

Acronym of Scientific Title:

EST-OBS-OZO-BIOPLA-SARS-COV 2

Secondary indentifying numbers:

Conv/COVID19/2020

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, OSDE 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:

Innnovation Committee

Authorization date :

08/06/2020

Reference number:

Principal investigator

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

First name:

Mario

Last name:

Delgado Guerra

Medical Specialty :

First Degree Specialist in Internal Medcine

Affiliation:

Hospital of the University of Informatics Sciences (UCI)

Postal address:

Carretera a San Antonio de los Bannos Km 2 1/2 Reparto Torrens

City:

Havana

Country:

Cuba

Zip Code:

19370

Telephone:

+53-52179900

Email address:

mario.delgado@infomed.sld.cu [1]

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:

Complete

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

SARS Virus

Coronaviridae Infections

Nidovirales Infections

Betacoronavirus

Health condition keyword:

COVID-19

SARS-CoV2

Intervention(s):

Group 1: Rectal ozonotherapy in combination with BIOPLA. Rectal ozonotherapy aplication (200 mL gas with 30 μg/mL ozono concentration), 5 days/week during 4 weeks plus BIOPLA (1 capsule-500mg)/dayafter lunch, during 4 weeks. Group 2: BIOPLA (1 capsule-500mg)/day after lunch, during 4 weeks.

Intervention code:

Medicine, Traditional

Administration, Rectal

Administration, Oral

Intervention keyword:

Ozone therapy, BIOPLA

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):

Physical-nutritional status (Body mass index [(weight (kg) / height (m)) measured as Poor, Normal, Excessive]; Arm circumference [Assessment of atrophy measured as Presence or Not]; Grip strength [Evolution of sarcopenia measured as Presence or not]).Measurement time: Baseline and, at the end of the 4th week of treatment

Key secondary outcomes:

Blood biochemical variables (Albumin (g / L), lactate dehydrogenase (LDH-UI), alanine amino transferase (ALT-U / L), aspartate amino transferase (AST-U / L), creatinine (umol / L), gamma-glutamyl transferase (GGT-U / L), glucose (mmol / L), biliribin (mmol / L), uric acid (mmol / L), cholesterol (mmol / L), triglycerides (mmol / L) and high-density lipoproteins ( HDL-mmol / L)). Measurement time: At baseline and after 4 weeks of treatment. Redox balance indicators (Pro-oxidants MDA and total hydroperoxides, Nitric oxide, Products of advanced protein oxidation; Antioxidants (Glutathione, SOD and CAT)). Measurement time: At baseline and after 4 weeks of treatment. Adverse events-AE (Occurrence of AE in patient (Yes/No); Description of AE (name of AE); Duration of AE (Date of start and stop of the AE); Intensity of AE (mild, moderate, severe); Attitude respect to study treatment (within changes, modification of dose, temporal or definitive interruption of study treatment); Relation of causality (highly probable, probable, possible, improbable, no related, no evaluable)). Measurement time: 4 weeks

Selection criterias

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

Gender:

Male/Female

Minimum age:

40 years

Maximum age:

80 years

Inclusion criteria:

Hospitalization patients convalescient with SARS-CoV 2, bewteen 40 and 80 years , both sexes, signed informed consent.

Exclusion criteria:

1) Patients with uncontrolled hypertiroidism 2) Patients with deficit of glucose-6-phosphateo-deshidrogenase 3) Non transmissible cronic diseases 4) Oncological patients 5) Patients with psiquiatric diseases 6) Surgery 7) Patients use inmunosupresant or patients with trasplant 8) Patiens with coagulation , trombocitopenia or active bleed 9) Allergic patients 10) Patients participate in other clinical trials 3 months before

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:

Non-randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

N/A

Target sample size:

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 Sciences

Affiliation:

National Center for Scientific Research

Postal Address:

Ave 25 y 158, Reparto Cubanacan, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72724841, +53-53056529

Email :

zullyt.zamora@cnic.cu [2]

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, Reparto Cubanacan, Playa.

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72724841, +53-53056529

Email :

zullyt.zamora@cnic.cu [2]

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

Study completion date:

15/08/2020

Date of available results:

15/10/2020

Date of first publication:

15/12/2020

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:

RPCEC00000342

Date of Registration in Primary Registry:

06/11/2020

Record Verification Date:

2020/12/21

Next update date:

2021/12/21

Link to the spanish version:

Click here [3]