COVID-19NCT04466644
COVID-19: A Prevalence Study of Two ART Centres After the Pandemic Lockdown in the USA (COVID-19 Free Clinics)
An observational study of COVID-19, run by Igenomix at 2 sites in United States.
Trial summary
In late December 2019, a new coronavirus strain emerged causing coronavirus disease 2019 (COVID19). Since then, COVID19 has become a global pandemic outbreak being declared a "public health emergency of international concern" by the International Health Regulations Emergency Committee of the WHO on January 30, 2020. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- ELISA and RT-PCR
- How many people
- 340 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Jun 2020to 25 Aug 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Mainly asymptomatic subjects composed by patients who are attending for their regular medical consultation and clinic staff for COVID-19 infection from the two participant sites, located in two areas with different pandemic status, before initiating the work immediately after the lockdown period.
Who may be able to join
- Age of majority subjects whose written informed consent approved by the IRB has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved.
- Site staff who are re-incorporating to the centers and patients who are attending their medical appointment for their regular IVF treatment.
- Mainly asymptomatic individuals from the ART clinics, before initiating the work right after the lockdown period.
- Note: COVID-19 symptomatology may appear 2-14 days after exposure to the virus and may include at least one of the following symptoms:
- Fever
- Cough
Show all 13Show fewer
- Shortness of breath or difficulty breathing
- Chills
- Repeated shaking with chills
- Muscle pain
- Headache
- Sore throat
- New loss of taste or smell
Who cannot join
- Not applicable as there is not exclusion criteria for this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston IVF Fertility Clinic
Boston, Massachusetts, 02109
Utah Fertility Clinic
Pleasant Grove, Utah, 84062
About this study
Official title: A Multicenter, Prevalence Study to Evaluate the Infectious and Immunological Status of COVID-19 in Asymptomatic Subjects Attending ART Centres After the Pandemic Lockdown in the USA
In late December 2019, a new coronavirus strain emerged causing coronavirus disease 2019 (COVID19). Since then, COVID19 has become a global pandemic outbreak being declared a "public health emergency of international concern" by the International Health Regulations Emergency Committee of the WHO on January 30, 2020. Several emergency measures have been implemented in different countries such as lockdown, social distancing, and testing.
The pandemic concerns to public worldwide but also to couples aiming to conceive through natural means or undergoing assisted reproductive technologies (ART). The American Society of Reproductive Medicine (ASRM) as well as European Society of Human Reproduction and Embryology (ESHRE) have recommend a precautionary approach and advise that all fertility patients considering or planning treatment, even if they do not meet the diagnostic criteria for COVID-19 infection, should avoid becoming pregnant at this time until more is known about the virus. Therefore, new cycles for infertility patients as well as non-medically urgent gamete preservation treatments, such as social egg freezing, have been suspended deferring embryo transfer in those patients with initiated cycles. In this moment, when reopening phases are being undertaken in most countries, the decision to resume the In vitro fertilization (IVF) treatment in a safe environment to the healthcare workers and patients is the biggest concern of the ART clinics.
The present study aims to describe the percentage of COVID-19 condition (naïve, immune, and currently infected) in asymptomatic individuals from two different ART centres. For this purpose, the ART centres' personnel and patients will be tested for COVID-19 before resume the clinic daily routine just after the lockdown period.
Read the detailed description
On March 11th 2020, WHO characterized COVID-19 as a pandemic and on March 13th, the President of the United States declared the COVID-19 outbreak a "national emergency". In order to fight this pandemic, emergency measures have been implemented in different countries such as lockdown, social distancing and testing. It is known that these measures have differed among countries and due to the lack of tests worldwide, the real number of affected and/or immunized people remains largely unknown. In this context, the daily most important surrogate markers have been the numbers of infected hospitalized and deceased population. However, asymptomatic infections are not uncommon (representing up to 30% of infected cases) and the detection of this population seems crucial to prevent their potential transmission and to guide the development of measures to control the ongoing pandemic.
This is a descriptive, prevalence study that aims to define the current contagious risk and immune status to SARS-CoV-2/COVID-19 infection in two reproduction health centers in the USA located in Utah and Massachusetts. Aiming for the better technical procedures available, different biological samples (nasopharyngeal swab, saliva, and blood sample) from each participant will be tested applying two different methodologies already approved by Health Authorities, and nowadays the most commonly used for the COVID-19 diagnose: Reverse Transcriptase - Polymerase Chain Reaction (RT-PCR) for the analysis of the nasopharyngeal swabs and saliva samples and Immunoassay by serology for the blood serum analysis.
A total of 400 participants, distributed equally between the two participant centers, are expected to be included in 2 months.The total expected duration of the study is 4 months for collecting, processing and analysing samples from participants (patients and clinical staff), although the participation in the study will entail just a single visit (coinciding with the same day of the samples collection). After that visit, no further interventions or follow-up directly related to this study will be required.
Data exported from the clinical histories and source documents will be duly codified to protect the clinical and personal information of patients in accordance with the current legislation. This information will be exported to an electronic Case Report Form (eCRF) for its analysis. Given the exceptional situation that the world is facing with the COVID-19 pandemic, U.S. authorities demand the report of all tested cases, so patient´s data will be communicated to the U.S. national health authorities when the result of the test is positive.
- Conditions
- COVID-19
- Being tested
- ELISA, RT-PCR
- Keywords
- SARS-CoV-2, Severe acute respiratory syndrome coronavirus 2, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISADiagnostic test
Antibody test (serology) in the blood samples to determine if the subject was previously infected.
RT-PCRDiagnostic test
For detecting the presence of SARS-CoV-2 RNA molecule in the nasopharyngeal swabs and saliva.
| Study group | Role | What they receive |
|---|---|---|
| The regulars of IVF clinics in the USA | Mainly asymptomatic individuals composed by patients who are attending their regular medical consultation and/ clinic staff of the participant sites, located in two areas of the USA with different pandemic status, and undergoing PCR and ELISA tests for diagnosis of COVID-19 before initiating the work after the lockdown. Receives: Diagnostic Test: ELISA; Diagnostic Test: RT-PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of contagiousness in asymptomatic individuals by PCR with nasopharyngeal swabs
Statistical quantification of the prevalence of contagiousness in asymptomatic individuals attending IVF clinics in the USA based on the gold standard test (PCR).
Measured: 2 months
Ratio of asymptomatic immunized (IgG) population
Statistical quantification of the rate of immunized (IgG) individuals attending to IVF clinics in the USA based on the ELISA test.
Measured: 2 months
Secondary outcomes (1)
To validate saliva specimens as a biological sample for COVID-19 testing
To validate the use of saliva specimen as a possible substitute to nasopharyngeal swabs, offering a simpler, easily self-sampling and large-scale test.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start8 Jun 2020
- Primary completion24 Aug 2020
- Study completion25 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Prospective
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Igenomix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juliana Cuzzi, PhD, Principal investigator, IgenomixCarlos Simon, MD, PhD, Principal investigator, Igenomix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466644
- Sponsor's protocol ID
- IGX2-COV-JC-20-04
- Other IDs
- 20201490
- Status last verified
- Sep 2020
- First submitted
- 9 Jul 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prevalence Study to Evaluate the Infectious and Immunological Status of COVID-19 in Asymptomatic Subjects Attending ART Centres After the Pandemic Lockdown in the USA
- ClinicalTrials.gov ID
- NCT04466644
- Acronym / sponsor ID
- IGX2-COV-JC-20-04
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, Severe acute respiratory syndrome coronavirus 2, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- IgenomixIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 24 Aug 2020 (actual)
- Study completion
- 25 Aug 2020 (actual)
- First posted
- 10 Jul 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.
In late December 2019, a new coronavirus strain emerged causing coronavirus disease 2019 (COVID19). Since then, COVID19 has become a global pandemic outbreak being declared a "public health emergency of international concern" by the International Health Regulations Emergency Committee of the WHO on January 30, 2020. Several emergency measures have been implemented in different countries such as lockdown, social distancing, and testing.
The pandemic concerns to public worldwide but also to couples aiming to conceive through natural means or undergoing assisted reproductive technologies (ART). The American Society of Reproductive Medicine (ASRM) as well as European Society of Human Reproduction and Embryology (ESHRE) have recommend a precautionary approach and advise that all fertility patients considering or planning treatment, even if they do not meet the diagnostic criteria for COVID-19 infection, should avoid becoming pregnant at this time until more is known about the virus. Therefore, new cycles for infertility patients as well as non-medically urgent gamete preservation treatments, such as social egg freezing, have been suspended deferring embryo transfer in those patients with initiated cycles. In this moment, when reopening phases are being undertaken in most countries, the decision to resume the In vitro fertilization (IVF) treatment in a safe environment to the healthcare workers and patients is the biggest concern of the ART clinics.
The present study aims to describe the percentage of COVID-19 condition (naïve, immune, and currently infected) in asymptomatic individuals from two different ART centres. For this purpose, the ART centres' personnel and patients will be tested for COVID-19 before resume the clinic daily routine just after the lockdown period.
Detailed description
On March 11th 2020, WHO characterized COVID-19 as a pandemic and on March 13th, the President of the United States declared the COVID-19 outbreak a "national emergency". In order to fight this pandemic, emergency measures have been implemented in different countries such as lockdown, social distancing and testing. It is known that these measures have differed among countries and due to the lack of tests worldwide, the real number of affected and/or immunized people remains largely unknown. In this context, the daily most important surrogate markers have been the numbers of infected hospitalized and deceased population. However, asymptomatic infections are not uncommon (representing up to 30% of infected cases) and the detection of this population seems crucial to prevent their potential transmission and to guide the development of measures to control the ongoing pandemic.
This is a descriptive, prevalence study that aims to define the current contagious risk and immune status to SARS-CoV-2/COVID-19 infection in two reproduction health centers in the USA located in Utah and Massachusetts. Aiming for the better technical procedures available, different biological samples (nasopharyngeal swab, saliva, and blood sample) from each participant will be tested applying two different methodologies already approved by Health Authorities, and nowadays the most commonly used for the COVID-19 diagnose: Reverse Transcriptase - Polymerase Chain Reaction (RT-PCR) for the analysis of the nasopharyngeal swabs and saliva samples and Immunoassay by serology for the blood serum analysis.
A total of 400 participants, distributed equally between the two participant centers, are expected to be included in 2 months.The total expected duration of the study is 4 months for collecting, processing and analysing samples from participants (patients and clinical staff), although the participation in the study will entail just a single visit (coinciding with the same day of the samples collection). After that visit, no further interventions or follow-up directly related to this study will be required.
Data exported from the clinical histories and source documents will be duly codified to protect the clinical and personal information of patients in accordance with the current legislation. This information will be exported to an electronic Case Report Form (eCRF) for its analysis. Given the exceptional situation that the world is facing with the COVID-19 pandemic, U.S. authorities demand the report of all tested cases, so patient´s data will be communicated to the U.S. national health authorities when the result of the test is positive.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The regulars of IVF clinics in the USA | – | Diagnostic Test: ELISA, Diagnostic Test: RT-PCRMainly asymptomatic individuals composed by patients who are attending their regular medical consultation and/ clinic staff of the participant sites, located in two areas of the USA with different pandemic status, and undergoing PCR and ELISA tests for diagnosis of COVID-19 before initiating the work after the lockdown. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Mainly asymptomatic subjects composed by patients who are attending for their regular medical consultation and clinic staff for COVID-19 infection from the two participant sites, located in two areas with different pandemic status, before initiating the work immediately after the lockdown period.
Key inclusion criteria (13 listed)
- Age of majority subjects whose written informed consent approved by the IRB has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved.
- Site staff who are re-incorporating to the centers and patients who are attending their medical appointment for their regular IVF treatment.
- Mainly asymptomatic individuals from the ART clinics, before initiating the work right after the lockdown period.
- Note: COVID-19 symptomatology may appear 2-14 days after exposure to the virus and may include at least one of the following symptoms:
- Fever
Key exclusion criteria (1 listed)
- Not applicable as there is not exclusion criteria for this study.
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 |
|---|---|---|
| ELISAAntibody test (serology) in the blood samples to determine if the subject was previously infected. | Diagnostic test | The regulars of IVF clinics in the USA |
| RT-PCRFor detecting the presence of SARS-CoV-2 RNA molecule in the nasopharyngeal swabs and saliva. | Diagnostic test | The regulars of IVF clinics in the USA |
Primary outcome
Prevalence of contagiousness in asymptomatic individuals by PCR with nasopharyngeal swabs
Time frame: 2 months
Statistical quantification of the prevalence of contagiousness in asymptomatic individuals attending IVF clinics in the USA based on the gold standard test (PCR).
Ratio of asymptomatic immunized (IgG) population
Time frame: 2 months
Statistical quantification of the rate of immunized (IgG) individuals attending to IVF clinics in the USA based on the ELISA test.
1 secondary outcome
To validate saliva specimens as a biological sample for COVID-19 testing
Time frame: 2 months
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 14 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Juliana Cuzzi, PhD principal investigator
Igenomix
Carlos Simon, MD, PhD principal investigator
Igenomix
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Igenomix at 2 sites in United States.
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 13 inclusion and 1 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 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Prevalence of contagiousness in asymptomatic individuals by PCR with nasopharyngeal swabs (time frame: 2 months). The study lists 2 primary outcomes in all. 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 14 Sep 2020.