Covid19NCT04581083
Validation of Laboratory Techniques, Strategies, and Types of Samples for Epidemiological Control in the Covid-19 Pandemic
An observational study of Covid19, run by Hunter College of City University of New York at 1 site in Bolivia.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- RT-PCR, LAMP and POOL RT-PCR
- How many people
- 30 participants
- Where
- 1 siteBolivia
- Study dates
- 8 Oct 2020to 30 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Laboratory Techniques, Strategies, and Types of Samples for Epidemiological Control in the Covid-19 Pandemic, Tarija-Bolivia
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.
- Conditions
- Covid19
- Being tested
- RT-PCR, LAMP, POOL RT-PCR, POOL LAMP
- Keywords
- COVID 19, Bolivia, Clinical Laboratory Techniques
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RT-PCRDiagnostic test
Also called Real-Time Polymerase Chain Reaction
RT-PCR (Gold standard): Real-time PCR testing with reverse transcriptase (RT-PCR). The test consists of a polymerase chain reaction that has previously had a reverse transcription phase, RT. This test allows the cADN (complementary DNA) to be obtained from a RNA chain. This technique allows the detection and amplification of a sequence from a strand of RNA.
LAMPDiagnostic test
Also called Loop-mediated isothermal amplification
LAMP: The LAMP technique, like PCR, has the ability to amplify specific DNA fragments (target sequence), allowing for highly sensitive detection of pathogens. Unlike pcr, LAMP requires between 4 and 6 feeders, external F3 and B3 feeders, which hybridte with the outer regions of the target sequence, while the internal FIP and BIP have sequences in both ways that allow the formation of a loop. The LAMP reaction is isothermal, i.e. it takes place at a single temperature. LAMP has been successfully used to detect viral diseases as well as viral pathogens such as West Nile virus, TMR-1, Norovirus, avian influenza, foot-and-mouth disease, classical swine fever, among others.
POOL RT-PCRDiagnostic test
Also called Pooled Real-Time Polymerase Chain Reaction
POOL RT-PCR: This test aims to mix in a single sample the extractions obtained from several people. The joint sample is evaluated and, if negative, it is understood that all are free of COVID-19; if it is positive, an array system is used to detect the affected person. That is, a single PCR (polymerase chain reaction), the diagnostic test used to detect the virus pathogen is applied to a group and repeated individually if positive.
POOL LAMPDiagnostic test
Also called Pooled Loop-mediated isothermal amplification
POOL LAMP: Like the RT-PCR pool test. This test essentially involves mixing in a single sample the extractions obtained from several people. This joint sample is tested and, if it is negative, it is understood that everyone is free of COVID-19; if it is positive, an array system is used to detect the affected person. That is: a single LAMP applies to a group
| Study group | Role | What they receive |
|---|---|---|
| Volunteer participants | Samples of volunteer participants will be collected after informed consent and classified as symptomatic, asymptomatic and negative. Receives: Diagnostic Test: RT-PCR; Diagnostic Test: LAMP; Diagnostic Test: POOL RT-PCR; Diagnostic Test: POOL LAMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation
Validate different molecular tests and sampling and sample type strategies used in epidemiological control of COVID-19 diagnosis in Tarija, Bolivia.
Measured: 1 month
Secondary outcomes (4)
RT- PCR (Saliva)
Validate the use of molecular testing based on the PCR method using Saliva samples
Measured: 1 week
LAMP
Validate the use of the molecular test based on the LAMP method using saliva and nasopharyngeal samples
Measured: 1 week
POOL PCR
Validate the use of molecular tests with Pool PCR strategy using saliva samples
Measured: 1 week
POOL LAMP
Validate the use of molecular tests with Pool LAMP strategy using saliva samples
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start8 Oct 2020
- Primary completion10 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunter College of City University of New York
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Autonoma Juan Misael Saracho, Gobierno Autonomo Departamental De Tarija, SEDES - Tarija, CAINCO - Bolivia, Universidad Mayor de San Simon
- Responsible party
- Principal investigator, Rodrigo Arce Cardozo, Hunter College of The City University of New York
- Investigators
- Kenji Shoji, PhD, Principal investigator, Lakefront Biotherapeutics NVRodrigo Arce Cardozo, MD, MPH, Study chair, City University of New York, School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581083
- Sponsor's protocol ID
- PROY - UAJMS001/2020
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2020
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share deidentified data
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Laboratory Techniques, Strategies, and Types of Samples for Epidemiological Control in the Covid-19 Pandemic, Tarija-Bolivia
- ClinicalTrials.gov ID
- NCT04581083
- Acronym / sponsor ID
- PROY - UAJMS001/2020
- Conditions
- Covid19
- Keywords
- COVID 19, Bolivia, Clinical Laboratory Techniques
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hunter College of City University of New YorkUniversity, hospital or other
- Collaborators
- Universidad Autonoma Juan Misael Saracho, Gobierno Autonomo Departamental De Tarija, SEDES - Tarija, CAINCO - Bolivia, Universidad Mayor de San Simon
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 10 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volunteer participants | – | Diagnostic Test: RT-PCR, Diagnostic Test: LAMP, Diagnostic Test: POOL RT-PCR, Diagnostic Test: POOL LAMPSamples of volunteer participants will be collected after informed consent and classified as symptomatic, asymptomatic and negative. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RT-PCRAlso: Real-Time Polymerase Chain ReactionRT-PCR (Gold standard): Real-time PCR testing with reverse transcriptase (RT-PCR). The test consists of a polymerase chain reaction that has previously had a reverse transcription phase, RT. This test allows the cADN (complementary DNA) to be obtained from a RNA chain. This technique allows the detection and amplification of a sequence from a strand of RNA. | Diagnostic test | Volunteer participants |
| LAMPAlso: Loop-mediated isothermal amplificationLAMP: The LAMP technique, like PCR, has the ability to amplify specific DNA fragments (target sequence), allowing for highly sensitive detection of pathogens. Unlike pcr, LAMP requires between 4 and 6 feeders, external F3 and B3 feeders, which hybridte with the outer regions of the target sequence, while the internal FIP and BIP have sequences in both ways that allow the formation of a loop. The LAMP reaction is isothermal, i.e. it takes place at a single temperature. LAMP has been successfully used to detect viral diseases as well as viral pathogens such as West Nile virus, TMR-1, Norovirus, avian influenza, foot-and-mouth disease, classical swine fever, among others. | Diagnostic test | Volunteer participants |
| POOL RT-PCRAlso: Pooled Real-Time Polymerase Chain ReactionPOOL RT-PCR: This test aims to mix in a single sample the extractions obtained from several people. The joint sample is evaluated and, if negative, it is understood that all are free of COVID-19; if it is positive, an array system is used to detect the affected person. That is, a single PCR (polymerase chain reaction), the diagnostic test used to detect the virus pathogen is applied to a group and repeated individually if positive. | Diagnostic test | Volunteer participants |
| POOL LAMPAlso: Pooled Loop-mediated isothermal amplificationPOOL LAMP: Like the RT-PCR pool test. This test essentially involves mixing in a single sample the extractions obtained from several people. This joint sample is tested and, if it is negative, it is understood that everyone is free of COVID-19; if it is positive, an array system is used to detect the affected person. That is: a single LAMP applies to a group | Diagnostic test | Volunteer participants |
Primary outcome
Validation
Time frame: 1 month
Validate different molecular tests and sampling and sample type strategies used in epidemiological control of COVID-19 diagnosis in Tarija, Bolivia.
4 secondary outcomes
RT- PCR (Saliva)
Time frame: 1 week
LAMP
Time frame: 1 week
POOL PCR
Time frame: 1 week
POOL LAMP
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Local Sponsor University WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We will share deidentified data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenji Shoji, PhD principal investigator
Lakefront Biotherapeutics NV
Rodrigo Arce Cardozo, MD, MPH study chair
City University of New York, School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Hunter College of City University of New York at 1 site in Bolivia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bolivia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.