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RecruitingNCT05188612ISACS-COVID-19Updated May 1, 2026

International Survey of Acute Coronavirus Syndromes-COVID-19

An observational study in COVID-19, sponsored by University of Bologna. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-01.

Sponsored by University of Bologna · Observational

From the registry’s dates

  • Started Dec 2021; still recruiting 4 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
10,000
Ages
18 Years and older
Sex
All
01

Study summary

In response to the COVID-19 crisis, ISACS-TC has promoted a new registry of the existing and further centers of the same geographic areas to support clinical research to prevent, and treat the COVID-19 illness. These efforts are made possible by the generous contributions of clinical research volunteers in some of the countries participating to the prior acute coronary syndrome network.

Read the detailed description

To address existing gaps in knowledge on CVD among European countries at different income levels, a collaboration of outcomes-oriented researchers from the University of Bologna partnered with Central and East European (CEE) countries researchers to conduct the International Survey of Acute Coronary Syndromes in Transitional Countries (ISACS-TC) investigating underlying threats in patients' CVD health status (NCT01218776).

In response to the COVID-19 crisis, ISACS-TC has promoted a new registry of the existing and further centers of the same geographic areas to support clinical research to prevent, and treat the COVID-19 illness. These efforts are made possible by the generous contributions of clinical research volunteers in some of the countries participating to the prior acute coronary syndrome network.

Scientific and clinical evidence is evolving on the effects of COVID-19, which can affect multiple organ systems. As, so the COVID-19 pandemic underscores the urgent need for coordination, collaboration, and information-sharing among researchers worldwide. Researchers of many disciplines have, therefore, joined the ISACS-TC investigators to build a multi-disciplinary registry investigating the impact of COVID-19.

Projects should be mainly focused on topics related to:

  1. The impact of COVID-19 infection on patients who have attended any health care center (within hospital beds), and who have been discharged or have died at the time of the evaluation. The main objective of this task is to carefully characterize the clinical profile of patients infected with COVID-19 in order to develop a simple prognostic clinical score allowing rapid logistic decision making such as discharge with follow-up, referral to provisional hospitals, or admission to hospital centers with advanced equipment or specialized procedures and techniques. A secondary objective of this retrospective analysis is to evaluate the risk-adjusted influence of prior evidence-based treatments and comorbidities on patients infected with the disease.
  2. The second issue relates to the long-term health consequences after COVID-19 infection. Early reports suggest residual effects of SARS-CoV-2 infection, such as fatigue, dyspnea, chest pain, cognitive disturbances, arthralgia, and decline in quality of life. However, the evidence is still scarce. Prior studies did not take into account the vast majority of patients with a mild course of the infection. As well, the definition of the post-acute COVID-19 timeline is evolving. Today we may summarize the post-acute COVID-19 syndrome into two categories:

    • subacute or ongoing symptomatic COVID-19, which includes symptoms and abnormalities present from 4-12 weeks beyond acute COVID-19;
    • chronic or post-COVID-19 syndrome, which includes symptoms and abnormalities persisting or present beyond 12 weeks of the onset of acute COVID-19 and not attributable to alternative diagnoses. Systematic study of sequelae after recovery from acute COVID-19 is needed to develop an evidence-based multidisciplinary team approach for caring for these patients, and to inform research priorities.

One trained physician will critically review the patients' reported symptoms and will assess SARS-CoV-2 IgG at each visit. In addition, wherever needed, the investigators will investigate the daily living status of survivors of COVID-19 using telephone interview questionnaires including Activity Daily Living (ADL), Self-rating Depression Scale (SDS), and New York Heart Association (NYHA) functional class.

  • Sponsor: Raffaele Bugiardini (Principal Investigator; PI) - University of Bologna
  • Co-PI Investigator (Clinical Research): Olivia Manfrini (University of Bologna)
  • Co-PI Investigator (Translational Research): Lina Badimon (IR-Hospital de la Santa Creu i Sant Pau, UAB, Barcelona)
  • Collaborator: Associazione Per La Ricerca Cardiologica, Roma

National Investigators:

Bosnia and Herzegovina: Local PI: Mirza Dilic (Clinical Center University of Sarajevo)

Croatia: Local PI: Davor Miličić (University Hospital Center Zagreb)

Other Investigators:

  • Marijan Pašalić (University Hospital Center Zagreb)
  • Petra Mjehović (University Hospital Center Zagreb)

Italy: Local PI: Stefano Nava (University of Bologna)

Other Investigators:

  • Gaetano Caramori (University of Messina)
  • Antonio David, (University of Messina)
  • Giuseppe Mancuso (University of Messina)
  • Maria Laura Vega Pitao (University of Bologna)
  • Giulia Panzuti (University of Bologna)
  • Edina Cenko (University of Bologna)
  • Maria Bergami (University of Bologna)
  • Marialuisa Scarpone (University of Bologna)
  • Antonio Spanevello (IRCCS Maugeri)
  • Fabio Angeli (IRCCS Maugeri)
  • Dina Visca (IRCCS Maugeri)
  • Martina Zappa (IRCCS Maugeri)
  • Paolo Emilio Puddu (Associazione Per La Ricerca Cardiologica, Roma)

Macedonia: Local PI: Sasko Kedev and Marija Vavlukis (University "Ss. Cyril and Methodius")

Other Investigators:

  • Lidija Poposka (University Clinic of Cardiology)
  • Milena Stefanovic (University Clinic of Infectious Diseases)
  • Ilir Demiri (University Clinic of Infectious Diseases) Romania: Local PI: Maria Dorobantu (Emergency Clinical Hospital of Bucharest) Other Investigators: Oana Fronea Gheorghe (Emergency Clinical Hospital of Bucharest)

Serbia: Local PI: Marija Zdravkovic (Hospital Medical Center Bezanijska kosa, Belgrade), Zorana Vasiljevic (University of Belgrade)

Other Investigators:

  • Nebojsa Ladjevic, Clinic for Anesthesia, Covid Hospital Batajnica, Belgrade
  • Radmilo Jankovic (Clinical Center Nis)
  • Goran Loncar (Institute for Cardiovascular Diseases Dedinje)
  • Ratko Lasica (Clinical Center of Serbia)
  • Miodrag Petrović (Institute for Cardiovascular Diseases Sremska Kamenica, Novi Sad)
  • Vlada Vukomanovic (Clinical Hospital Center Dragiša Mišković Belgrade)
  • Dubravka Rajic (Clinical Center of Serbia)
  • Ana Uscumlic (Clinical Center of Serbia)
  • Sanja Stankovic (Clinical Center of Serbia)

Spain: Local PI: Teresa Padro (IR-Hospital de la Santa Creu i Sant Pau, UAB, Barcelona)

Other Investigators:

  • Guiomar Mendieta ( CNIC, Madrid)
  • Rosa Suades (IR-Hospital de la Santa Creu i Sant Pau, UAB, Barcelona)
  • Gemma Vilahur (IR-Hospital de la Santa Creu i Sant Pau, UAB, Barcelona)

United Kingdom: Local PI: Charalambos Antoniades (Oxford University)

Other Investigators:

  • Maria Lyasheva (University of Oxford)
  • Lucy Kingham (University of Oxford)
  • Christos Kotanidis (University of Oxford)
  • Cheng Xie (University of Oxford)
02

Conditions studied

  • COVID-19

Browse trials for

03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 268 across 3,208 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

University of Bologna is the lead sponsor of 158 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Confirmed diagnosis of COVID-19 infection.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18 years (male or female)
  • Patients admitted to any hospital center with a confirmed diagnosis of COVID-19 infection.

Exclusion criteria

Exclusion Criteria:

  • Underage or not able to give
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
10,000 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Male

    Non-interventional patient registry

    Combination Product: Observational (registry)

  • Female

    Non-interventional patient registry

    Combination Product: Observational (registry)

  • Elderly

    Non-interventional patient registry

    Combination Product: Observational (registry)

  • Hypertension

    Non-interventional patient registry

    Combination Product: Observational (registry)

  • Diabetes

    Non-interventional patient registry

    Combination Product: Observational (registry)

  • Dyslipidemias

    Non-interventional patient registry

    Combination Product: Observational (registry)

  • Smoking

    Non-interventional patient registry

    Combination Product: Observational (registry)

  • Kidney Disease

    Non-interventional patient registry

    Combination Product: Observational (registry)

  • Heart Diseases

    Non-interventional patient registry

    Combination Product: Observational (registry)

  • Vascular diseases

    Non-interventional patient registry

    Combination Product: Observational (registry)

Interventions

  • Combination productObservational (registry)

    Observational (Patient Registry)

06

What researchers measure

Primary outcomes

  1. Death all cause

    Occurrence of all cause death

    Time frame: 30-day

  2. Death all cause

    Occurrence of all cause death

    Time frame: 6 month

  3. Death all cause

    Occurrence of all cause death

    Time frame: 12-month

Secondary outcomes

  1. Heart failure

    Occurrence of heart failure or worsening of preexisting heart failure (According to the attending physician)

    Time frame: 30 day, 6 -12 months

  2. Worsening renal function

    Occurrence of kidney disease or worsening of preexisting kidney failure (According to the attending physician)

    Time frame: 30 day, 6 -12 months

  3. Respiratory Insufficiency

    Occurrence of respiratory insufficiency or worsening of preexisting respiratory insufficiency (According to the attending physician)

    Time frame: 30 day, 6 -12 months

  4. Pneumonia

    Occurrence of pneumonia (According to the attending physician)

    Time frame: 30 day, 6 -12 months

  5. Sepsis

    Occurrence of sepsis (According to the attending physician)

    Time frame: 30 day, 6 -12 months

  6. Systemic Inflammatory Response Syndrome (SIRS)

    Occurrence of SIRS (According to the attending physician)

    Time frame: 30 day, 6 -12 months

  7. Thrombosis (arterial, venous)

    Occurrence of thrombosis and thromboembolism (According to the attending physician)

    Time frame: 30 day, 6 -12 months

  8. Clinically relevant bleeding

    Occurrence of clinically relevant bleeding (According to the attending physician)

    Time frame: 30 day, 6 -12 months

  9. Activity Daily Living status

    (According to the attending physician)

    Time frame: 30 day, 6 -12 months

  10. Depression status

    (According to the attending physician)

    Time frame: 30 day, 6 -12 months

07

Study locations

2 of 2 sites recruiting
  • University of Bologna
    Bologna, Bologna 40138, Italy
    Recruiting
    • Olivia Manfrini · Contact
  • IR-Hospital de la Santa Creu i Sant Pau, UAB
    Barcelona, Spain
    Recruiting
    • Lina Badimon · Contact
08

References and documents

Publications

  • Bugiardini R, Nava S, Caramori G, Yoon J, Badimon L, Bergami M, Cenko E, David A, Demiri I, Dorobantu M, Fronea O, Jankovic R, Kedev S, Ladjevic N, Lasica R, Loncar G, Mancuso G, Mendieta G, Milicic D, Mjehovic P, Pasalic M, Petrovic M, Poposka L, Scarpone M, Stefanovic M, van der Schaar M, Vasiljevic Z, Vavlukis M, Vega Pittao ML, Vukomanovic V, Zdravkovic M, Manfrini O. Sex differences and disparities in cardiovascular outcomes of COVID-19. Cardiovasc Res. 2023 May 22;119(5):1190-1201. doi: 10.1093/cvr/cvad011. PubMed 36651866 ↗
  • Bergami M, Manfrini O, Nava S, Caramori G, Yoon J, Badimon L, Cenko E, David A, Demiri I, Dorobantu M, Fabin N, Gheorghe-Fronea O, Jankovic R, Kedev S, Ladjevic N, Lasica R, Loncar G, Mancuso G, Mendieta G, Milicic D, Mjehovic P, Pasalic M, Petrovic M, Poposka L, Scarpone M, Stefanovic M, van der Schaar M, Vasiljevic Z, Vavlukis M, Vega Pittao ML, Vukomanovic V, Zdravkovic M, Bugiardini R. Relationship Between Azithromycin and Cardiovascular Outcomes in Unvaccinated Patients With COVID-19 and Preexisting Cardiovascular Disease. J Am Heart Assoc. 2023 Jul 18;12(14):e028939. doi: 10.1161/JAHA.122.028939. Epub 2023 Jul 14. PubMed 37449568 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05188612
Collaborators
Associazione Per La Ricerca Cardiologica (Roma)
Responsible party
Raffaele Bugiardini (Professor, University of Bologna) — Principal investigator
First posted
Jan 12, 2022
Start date
Dec 1, 2021
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 1, 2026

Study contacts

Raffaele Bugiardini, MD
Contact
raffaele.bugiardini@unibo.it
+39 051 347290
Olivia Manfrini, MD
Contact
olivia.manfrini@unibo.it
+39 051 2143778
Olivia Manfrini, MD
study director · University of Bologna
Lina Badimon, PhD
study director · IR-Hospital de la Santa Creu i Sant Pau, UAB, Barcelona

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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