Clinical trial NCT04581083: Validation of Laboratory Techniques, Strategies, and Types of Samples for Epidemiological Control in the Covid-19 Pandemic
Official title: Validation of Laboratory Techniques, Strategies, and Types of Samples for Epidemiological Control in the Covid-19 Pandemic, Tarija-Bolivia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: COVID 19
Bolivia
Clinical Laboratory Techniques
Lead sponsor: Hunter College of City University of New York
Sponsor class: OTHER
Collaborators: name: Universidad Autonoma Juan Misael Saracho
name: Gobierno Autonomo Departamental De Tarija
name: SEDES - Tarija
name: CAINCO - Bolivia
name: Universidad Mayor de San Simon
First posted: 2020-10-09
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Validation will be carried out using samples from volunteer adults from the municipality of Tarija, Bolivia, without gender restriction. Samples will be grouped according to the clinical classification determined above. These individuals will need to sign the informed consent form required to agree to be part of the study and provide their complete information or access to their medical history.

Brief summary: This is a study of validation for diagnostic techniques used on epidemiological control in the COVID-19 pandemic. It will be carried out in accredited public, private and university clinical laboratories of the collaborator institutions of the project based in Tarija, Bolivia. It is designed as a sectional validation study, using samples from specific groups of participants from the municipality of Tarija grouped according to their category with respect to symptoms and viral load of COVID-19. The sample is selected for convenience.


Eligibility criteria: Inclusion criteria:

* Symptomatic: Subjects with signs and symptoms of respiratory infection less than or equal to 3 days, preferably with clinical and molecular diagnosis compatible with Covid-19.
* Asymptomatics: Subjects who have had direct contact with people infected and who have not shown any symptoms related to Covid-19.
* Negative: Individuals with negative RT-PCR testing for SARS-CoV-2 (reference test) who have not manifested any symptoms seven days prior to sampling.

Exclusion criteria:

* Adults under the age of 21 or over 65
* Subjects with a clinical history of autoimmune disease or chemotherapy treatments.
* Subjects who have received transfusions or convalescent plasma in the last month prior to enrollment.
* Subjects with prior diagnosis of other infectious diseases such as, but not limited to AIDS, Hepatitis B or C, Tuberculosis, or any other ongoing or unresolved diseases.
* Subjects with malformation or oncological pathology of the upper respiratory track that may hinder sample collection, including but not limited to deviated septum, allergic rhinitis.
* Subjects who have not signed or can not sign the informed consent form
* Subjects not able to provide their complete information or access to their clinical history.

Primary outcomes:
measure: Validation
timeFrame: 1 month
Secondary outcomes:
measure: RT- PCR (Saliva)
timeFrame: 1 week
measure: LAMP
timeFrame: 1 week
measure: POOL PCR
timeFrame: 1 week
measure: POOL LAMP
timeFrame: 1 week
Other outcomes:
Locations:
city: Tarija
country: Bolivia
facility: Universidad Autónoma Juan Misael Saracho
Study officials:
affiliation: Galapagos NV
name: Kenji Shoji, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: City University of New York, School of Public Health
name: Rodrigo Arce Cardozo, MD, MPH
role: STUDY_CHAIR
References: