Clinical trial NCT04466644: COVID-19: A Prevalence Study of Two ART Centres After the Pandemic Lockdown in the USA (COVID-19 Free Clinics)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: SARS-CoV-2
Severe acute respiratory syndrome coronavirus 2
COVID-19
Lead sponsor: Igenomix
Sponsor class: INDUSTRY
First posted: 2020-07-10
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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
* Shortness of breath or difficulty breathing
* Chills
* Repeated shaking with chills
* Muscle pain
* Headache
* Sore throat
* New loss of taste or smell

Exclusion Criteria:

• Not applicable as there is not exclusion criteria for this study.

Primary outcomes:
measure: Prevalence of contagiousness in asymptomatic individuals by PCR with nasopharyngeal swabs
timeFrame: 2 months
measure: Ratio of asymptomatic immunized (IgG) population
timeFrame: 2 months
Secondary outcomes:
measure: To validate saliva specimens as a biological sample for COVID-19 testing
timeFrame: 2 months
Other outcomes:
measure: Description of demographic characteristics
timeFrame: 2 months
Locations:
city: Boston
country: United States
facility: Boston IVF Fertility Clinic
state: Massachusetts
city: Pleasant Grove
country: United States
facility: Utah Fertility Clinic
state: Utah
Study officials:
affiliation: Igenomix
name: Juliana Cuzzi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Igenomix
name: Carlos Simon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: