Revisiones para PrevengHo-Vir Homeoprohylaxis COVID-2019 | Registro Público Cubano de Ensayos Clínicos

Revisión actual:

PrevengHo-Vir Homeoprohylaxis COVID-2019

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:

PREVENGHO-COVID

Scientific title:

Homeoprophylaxis safety study with PrevengHo®-Vir in the context of the COVID-19 pandemic in Cuba. Quasi-experimental study post-registration (COVID-19)

Acronym of Scientific Title:

PREVENGHO-COVID

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Ministry of Public Health, Republic of Cuba

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:

Only approved by Ethics Committees

Principal investigator

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

First name:

Johann

Last name:

Perdomo Delgado

Medical Specialty :

Natural and Traditional Medicine

Affiliation:

Ministry of Public Health

Postal address:

201, 23rd St. Vedado. Revolution Square.

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78396304

+53-52700823

Email address:

tradicional@msp.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:

Santiago de Cuba, Camilo Torres Polyclinic, Carlos Eugenio Royo Lafita, MD. First Degree Specialist in Family Medicine and Natural and Traditional Medicine

Santiago de Cuba, Carlos J. Finlay Polyclinic, Elsida Lucía Rey Robira, MD. First Degree Specialist in Family Medicine and Natural and Traditional Medicine

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

29/04/2020

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-2019

Health condition(s) code:

Coronavirus Infections

SARS Virus

Coronaviridae Infections

Betacoronavirus

Health condition keyword:

COVID-19

SARS-CoV-2

Intervention(s):

The homeopathic remedy PrevengHo®-Vir will be used. Five drops diluted in two ounces of drinking water will be administered, once a day for three consecutive days and another single dose one week later (tenth day). It will be indicated to retain it in the mouth for five seconds, guaranteeing sublingual contact. Direct sublingual administration of the drug will be prohibited in all cases, to avoid contamination of the bottle and possible transmission of acute respiratory infections. Study group (PrevengHo-Vir is administered), office 4, "Camilo Torres" Polyclinic. Control group (will not receive PrevengHo-Vir, six weeks later it will be administered) office 11, Carlos J Finlay Polyclinic. Both of the Popular Council "José María Heredia".

Intervention code:

Homeopathic Remedy

Administration, Oral

Intervention keyword:

PrevengHo®-Vir

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):

Safety (Safety of the product for each patient once the safety assessment stage has been completed. Yes: once this stage is completed, the patient will not have any type of adverse event (AE), or those who will report are mild, related or not to PrevengHo®-Vir. No: once this stage was completed, the patient reported any AE with moderate or severe intensity, severe or non-severe, related to PrevengHo®-Vir). Measurement time: Close of the sixth week.

Key secondary outcomes:

1. Type of Adverse Event-AE (Clinical manifestations that appear as an unwanted effect; according to symptoms, signs and syndromes). Measurement time: Weekly, during the first six weeks of the study. 2. Severity (Risk of the effect caused by an AE in an individual. Serious: Death of the patient, threat to the life of the subject, requires hospitalization or prolongs an existing hospitalization, produces significant or persistent disability/invalidity. Non-serious: Does not meet any of the above requirements). Measurement time: Weekly, during the first six weeks of the study. 3. Intensity (Graduation in which an AE can be presented. Mild: It is well tolerated, causes minimal discomfort and does not interfere with daily activities. Moderate: Annoying enough to prevent or interfere with daily activities. Severe: Prevents daily activities). Measurement time: Weekly, during the first six weeks of the study. 4. Imputability (Degree of medication-AE association, according to the algorithm of Karch and Lasagna. Definitive: Clinical event that occurs in a plausible temporal relationship with the administration of the drug, which cannot be explained by the disease, another drug, or another chemical, disappears when the drug is withdrawn and reappears with the re-exposure to the drug. Likely: The above conditions are met except that there is no re-exposure or the information is unknown. Possible: Clinical event, with a reasonable time sequence with the administration of the drug, which can also be explained by the disease, another drug or another chemical substance, the information about the suspension of the use of the drug may be absent or not clear. Not related to the clinical event: It has no causal relationship with the product used). Measurement time: Weekly, during the first six weeks of the study. 5. Outcome of the AE in relation to the patient (Final situation that the patient arrives after having the EA. Recovered: The patient resolved the EA and recovered his state of health. Not Recovered: EA is maintained. Recovered with sequela: The EA is resolved but some sequel remains in the patient. Deadly: The patient dies). Measurement time: Weekly, during the first six weeks of the study. 6. Episodes of Acute Respiratory Infection-ARI (If the patient presented any manifestation of ARI symptoms, according to its definition. Yes: Incidence of IRA episodes. No: ARI is not diagnosed). Measurement time: Monthly, up to December 31rst, 2020. 7. Symptoms presented (These are the symptoms of an ARI episode. According to incidence (Yes/No) of symptoms (fever, cough, sore throat, shortness of breath, joint pain/myalgia, others)). Measurement time: Monthly, up to December 31rst, 2020. 8. Intensity of the episodes (Degrees in which the episode of IRA occurs. Mild: Episode well tolerated, causes minimal discomfort and does not interfere with daily activities. Moderate: Episode bothersome enough to impede or interfere with daily activities. Severe: Episode that prevents daily activities and leads to hospital admission). Measurement time: Monthly, up to December 31rst, 2020. 9. Duration of the episode in days (Duration of the IRA episode). Measurement time: Monthly, up to December 31rst, 2020.

Selection criterias

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

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

64 years

Inclusion criteria:

1. Individuals between 18 and 64 years of age. 2. Individuals without any respiratory symptoms at the time of administration of PrevengHo®-Vir.

Exclusion criteria:

1. Individuals allergic to any of the components of the homeopathic medicine.

Type of population:

Adults

Type of participant:

Healthy volunteers

Study design

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

Type study:

Observational

Purpose:

Prevention

Allocation:

Non-randomized controlled trial

Masking:

Open

Control group:

No intervention

Study design:

Parallel

Phase:

N/A

Target sample size:

180

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:

Johann

Last Name:

Perdomo Delgado

Specialty:

Natural and Traditional Medicine

Affiliation:

Department of Natural and Traditional Medicine, Ministry of Public Health, Republic of Cuba

Postal Address:

201, 23rd St. Vedado. Revolution Square.

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78396304

Email :

tradicional@msp.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:

Johann

Last Name:

Perdomo Delgado

Specialty:

Natural and Traditional Medicine

Affiliation:

Department of Natural and Traditional Medicine, Ministry of Public Health, Republic of Cuba

Postal Address:

201, 23rd St. Vedado. Revolution Square.

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78396304

Email :

tradicional@msp.sld.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

Comite de Etica de la Investigacion en Salud Provincial de Santiago de Cuba

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

27/04/2020

Postal address of Ethic Committee :

Avenida de las Americas y calle E, Reparto Suenno, Santiago de Cuba. Cuba. CP: 90100

Telephone:

+53-22641608

Correo electrónico:

aibosch@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

60

Study completion date:

31/12/2020

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:

RPCEC00000312

Date of Registration in Primary Registry:

13/05/2020

Record Verification Date:

2020/08/13

Next update date:

2021/08/13

Link to the spanish version:

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