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SyphilisSIPANDNCT07150871

Impact of Covid-19 on Syphilis

An observational study of Syphilis and COVID - 19, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Sexually transmitted infections (STIs) represent a significant challenge to global public health. Although many of these infections are treatable, failure to diagnose and delayed treatment can lead to serious complications, including infertility, chronic inflammatory diseases, and an increased risk of HIV… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Patients diagnosed with syphilis
How many people
240 participants
Where
1 siteItaly
Study dates
28 May 2025to 28 May 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients aged ≥18 years with a microbiological and/or clinical diagnosis of syphilis, treated by the Infectious Diseases Department of the University Hospital of Alessandria from 2017 to 2025

Who may be able to join

  • Patients aged ≥18 years
  • Patients with microbiological and/or clinical diagnosis of syphilis
  • Patients treated by the Infectious Diseases Department of the University Hospital of Alessandria
  • Signature of informed consent form

Who cannot join

  • Patients for whom the data required for the study are not available in medical records or electronic filing systems

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Clinical Trial Center

    Alessandria, Piedmont, 15121

Other trials in Italy

About this study

Official title: Impact of the COVID-19 Pandemic on Syphilis: Epidemiological Changes and Interaction With HIV

Sexually transmitted infections (STIs) represent a significant challenge to global public health. Although many of these infections are treatable, failure to diagnose and delayed treatment can lead to serious complications, including infertility, chronic inflammatory diseases, and an increased risk of HIV transmission. The COVID-19 pandemic has had a significant impact on healthcare management, the economy, and citizens' lifestyles. The first lockdown in the spring of 2020 affected the entire country, while in the following months, government measures were differentiated on a regional basis, with varying restrictions on activities and mobility. Physical distancing, the use of personal protective equipment, fear of contagion, and health restrictions contributed to a delay in STI diagnoses, resulting in an increase in transmission and severity of cases diagnosed after 2022.

Read the detailed description

Syphilis is a chronic infectious disease with a prolonged course, characterized by considerable clinical variability, so much so that it is referred to as the great imitator, due to its ability to manifest itself with symptoms that can mimic numerous other diseases. The clinical picture develops through alternating phases of activity, with obvious symptomatic manifestations, and latency, in which the infection remains silent in the body. It is a globally widespread infection, transmitted mainly through sexual contact, although it can also be transmitted congenitally or through direct contact with infected lesions. The relationship between syphilis and HIV is of growing clinical importance due to increasing rates of co-infection and the particular interaction between these two STIs. Syphilis facilitates the transmission and acquisition of HIV, while HIV infection accelerates the natural progression of syphilis. In addition, HIV has been associated with false positive and false negative results in serological tests for syphilis, complicating the diagnosis and management of the disease. A study conducted by the Department of Medicine in Toronto and the Ministry of Health showed that, in individuals with latent syphilis, the prevalence of HIV remained stable between 1991 and 2012, but increased approximately fivefold from 2012 to 2020, reaching a peak of 52.6%. In 2022, the Ministry of Health reported that syphilis cases had doubled compared to 2018, with incidence rising from 2.5 to 4.3 cases per 100,000 inhabitants. Gonorrhea increased from 1.5 to 3.3 cases per 100,000 inhabitants during the same period. Chlamydia, although less documented than in other European countries, also showed an upward trend, with 1,396 cases per 100,000 inhabitants in 2022. The COVID-19 pandemic has had a significant impact on healthcare management, the economy, and citizens' lifestyles. The first lockdown in the spring of 2020 affected the entire country, while in the following months, government measures were differentiated on a regional basis, with varying restrictions on activities and mobility. Physical distancing, the use of personal protective equipment, fear of contagion, and health restrictions contributed to a delay in STI diagnoses, resulting in an increase in transmission and severity of cases diagnosed after 2022. A study published in BMJ Open in 2021 analyzed the impact of the pandemic on healthcare services compared to previous years. The systematic review highlighted a 37% reduction in access to care, with decreases of 42% for outpatient visits, 28% for hospitalizations, 31% for diagnostics, and 30% for therapies. The pandemic has therefore significantly reduced the use of healthcare services, with a greater impact on people with non-serious conditions.

Being tested
Patients diagnosed with syphilis
Medical subject headings
Syphilis, COVID-19, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patients diagnosed with syphilisOther

    Collection of clinical data from patients aged ≥18 years with a microbiological and/or clinical diagnosis of syphilis, treated by the Infectious Diseases Department of the University Hospital of Alessandria from 2017 to 2025.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Trend of syphilis

    Analyze the trend of syphilis before and after the COVID-19 pandemic

    Measured: Baseline

Secondary outcomes (3)
  1. Characteristics of affected patients

    Describe the characteristics of patients with syphilis referred to the Infectious Diseases Unit of the SS Antonio e Biagio e Cesare Arrigo University Hospital in Alessandria between 2017 and 2025.

    Measured: Baseline

  2. Interaction between syphilis and HIV

    Examine the interaction between syphilis and HIV in a post-pandemic context, identifying how the pandemic has affected co-infection between syphilis and HIV, monitoring any changes in co-infection rates.

    Measured: Baseline

  3. Infection Recurrence Rate

    Evaluate the infection recurrence rate, calculated by taking the date of recovery from the original infection as the baseline and the onset of the same infection as the event of interest

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2025
  2. Study start28 May 2025
  3. Primary completion16 Jun 2025
  4. Study completion28 May 2026 (estimated)

Resources

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
Cohort
Time perspective
Retrospective
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07150871
Sponsor's protocol ID
ASO.Minf.25.01
Acronym
SIPAND
Status last verified
Aug 2025
First submitted
27 Aug 2025
Last updated
2 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Syphilis and COVID - 19, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.

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 4 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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2025. 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 Italy. 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?

This study is still under way. Results are not available in the source record yet.

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?

Trend of syphilis (time frame: Baseline). 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 2 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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