Curmeric-Prevention-COVID-19-Health Workers-University Hospital General Calixto Garcia

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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.

Scientific title:

Observational study about the prophylactic effect and the security of Curmeric in COVID- 19 administered to the health workers in the University Hospital General Calixto Garcia. (COVID-19)

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Center for Technological Applications and Nuclear Development (CEADEN), University Hospital General Calixto García, Ministery of Public Health

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:

Yanet

Last name:

Morejon Diaz

Medical Specialty :

First degree specialist in General Integral Medicine and First degree specialist in Hygiene and Epidemiology

Affiliation:

University Hospital General Calixto Garcia

Postal address:

University Avenue and J street. Revolution Square

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78982171

Email address:

secdircg@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:

Complete

Date of first enrollment:

19/03/2020

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:

Disease Prevention

Coronavirus Infections

SARS Virus

Coronaviridae Infections

Nidovirales Infections

Betacoronavirus

Health condition keyword:

COVID-19

SARS-CoV2

Intervention(s):

Group I, Curmeric. Natural product with Curcuma longa extracts- intellectual property under request-(oral) 4mL gargars/mouth wash after main meals for 1 month. Group II, No intervention In the study group (group I) was included the hospital workers more exposed to patients with respiratory diseases and, in the control group (group II) was included less exposed hospital workers

Intervention code:

Curcuma

Administration, Oral

Intervention keyword:

mouthwashes, gargles

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):

Patient confirmed with COVID-19 (Yes, No). Measurement time: 1 month

Key secondary outcomes:

Adverse Events-AE (Occurrence of AE (Yes, No); Type of event (name of AE); Intensity of AE (Mild, Moderate, Severe); Result (Recovered, Not recovered, Recovered with sequelae, Death); Required treatment (Yes, No)). Measurement time: 1 month

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:

85 years

Inclusion criteria:

Workers of the University Hospital General Calixto Garcia form the departments/services of first and second level of exposition to the patients with respiratory diseases and presencial work.

Exclusion criteria:

Known allergy to turmeric

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:

199

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:

Tania

Last Name:

Valdes Gonzalez

Specialty:

Pharmautical Sciences, PhD

Affiliation:

Center for Technological Applications and Nuclear Development (CEADEN)

Postal Address:

30th street and 5th Av. Playa

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-72022566-09

Email :

taniajapon@gmail.com

taniavaldes@infomed.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:

Tania

Last Name:

Valdes Gonzalez

Specialty:

Pharmaceutical Sciences, PhD

Affiliation:

Center for Technological Applications and Nuclear Development (CEADEN)

Postal Address:

30th street and 5th Av. Playa

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-72022566-09

Email :

taniajapon@gmail.com

taniavaldes@infomed.sld.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

General Calixto Garcia University Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

16/03/2020

Postal address of Ethic Committee :

Avenue Universidad and street J. Revolution Square. Havana, ZC:10400, Cuba

Telephone:

+53-78382171

Email:

secdircg@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

199

Study completion date:

18/04/2020

Date of available results:

30/11/2020

Date of first publication:

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:

RPCEC00000344

Date of Registration in Primary Registry:

24/11/2020

Record Verification Date:

2020/11/24

Next update date:

2021/11/24

Link to the spanish version:

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Registered Trials

Registration process

Curmeric-Prevention-COVID-19-Health Workers-University Hospital General Calixto Garcia

About the RPCEC

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