COVID-19ISACS-COVID-19NCT05188612
International Survey of Acute Coronavirus Syndromes-COVID-19
An observational study of COVID-19, run by University of Bologna at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Observational (registry)
- How many people
- 10,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Dec 2021to 31 Dec 2026
- How long will I take part?
- 1 Year
- 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: Confirmed diagnosis of COVID-19 infection.
Who may be able to join
- Age ≥18 years (male or female)
- Patients admitted to any hospital center with a confirmed diagnosis of COVID-19 infection.
Who cannot join
- Underage or not able to give informed consent
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Italy1 site, 1 recruiting
- Recruiting
University of Bologna
Bologna, Bologna, 40138
Olivia Manfrini
Spain1 site, 1 recruiting
- Recruiting
IR-Hospital de la Santa Creu i Sant Pau, UAB
Barcelona
Lina Badimon
About this study
Official title: International Survey of Acute Coronavirus Syndromes (ISACS)-COVID-19
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:
- 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.
- 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)
- Conditions
- COVID-19
- Being tested
- Observational (registry)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational (registry)Combination product
Observational (Patient Registry)
| Study group | Role | What they receive |
|---|---|---|
| Male | Non-interventional patient registry Receives: Combination Product: Observational (registry) | |
| Female | Non-interventional patient registry Receives: Combination Product: Observational (registry) | |
| Elderly | Non-interventional patient registry Receives: Combination Product: Observational (registry) | |
| Hypertension | Non-interventional patient registry Receives: Combination Product: Observational (registry) | |
| Diabetes | Non-interventional patient registry Receives: Combination Product: Observational (registry) | |
| Dyslipidemias | Non-interventional patient registry Receives: Combination Product: Observational (registry) | |
| Smoking | Non-interventional patient registry Receives: Combination Product: Observational (registry) | |
| Kidney Disease | Non-interventional patient registry Receives: Combination Product: Observational (registry) | |
| Heart Diseases | Non-interventional patient registry Receives: Combination Product: Observational (registry) | |
| Vascular diseases | Non-interventional patient registry Receives: Combination Product: Observational (registry) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death all cause
Occurrence of all cause death
Measured: 30-day
Death all cause
Occurrence of all cause death
Measured: 6 month
Death all cause
Occurrence of all cause death
Measured: 12-month
Secondary outcomes (10)
Heart failure
Occurrence of heart failure or worsening of preexisting heart failure (According to the attending physician)
Measured: 30 day, 6 -12 months
Worsening renal function
Occurrence of kidney disease or worsening of preexisting kidney failure (According to the attending physician)
Measured: 30 day, 6 -12 months
Respiratory Insufficiency
Occurrence of respiratory insufficiency or worsening of preexisting respiratory insufficiency (According to the attending physician)
Measured: 30 day, 6 -12 months
Pneumonia
Occurrence of pneumonia (According to the attending physician)
Measured: 30 day, 6 -12 months
Sepsis
Occurrence of sepsis (According to the attending physician)
Measured: 30 day, 6 -12 months
Systemic Inflammatory Response Syndrome (SIRS)
Occurrence of SIRS (According to the attending physician)
Measured: 30 day, 6 -12 months
Thrombosis (arterial, venous)
Occurrence of thrombosis and thromboembolism (According to the attending physician)
Measured: 30 day, 6 -12 months
Clinically relevant bleeding
Occurrence of clinically relevant bleeding (According to the attending physician)
Measured: 30 day, 6 -12 months
Activity Daily Living status
(According to the attending physician)
Measured: 30 day, 6 -12 months
Depression status
(According to the attending physician)
Measured: 30 day, 6 -12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start1 Dec 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Per La Ricerca Cardiologica (Roma)
- Responsible party
- Principal investigator, Raffaele Bugiardini, University of Bologna
- Investigators
- Olivia Manfrini, MD, Study director, University of BolognaLina Badimon, PhD, Study director, IR-Hospital de la Santa Creu i Sant Pau, UAB, Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188612
- Sponsor's protocol ID
- ISACS-COVID-19
- Acronym
- ISACS-COVID-19
- Status last verified
- Apr 2026
- First submitted
- 8 Jan 2022
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 36651866Bergami 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
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Survey of Acute Coronavirus Syndromes (ISACS)-COVID-19
- ClinicalTrials.gov ID
- NCT05188612
- Acronym / sponsor ID
- ISACS-COVID-19 / ISACS-COVID-19
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Collaborators
- Associazione Per La Ricerca Cardiologica (Roma)
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Jan 2022 (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 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.
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:
- 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.
- 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)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Male | – | Combination Product: Observational (registry)Non-interventional patient registry |
| Female | – | Combination Product: Observational (registry)Non-interventional patient registry |
| Elderly | – | Combination Product: Observational (registry)Non-interventional patient registry |
| Hypertension | – | Combination Product: Observational (registry)Non-interventional patient registry |
| Diabetes | – | Combination Product: Observational (registry)Non-interventional patient registry |
| Dyslipidemias | – | Combination Product: Observational (registry)Non-interventional patient registry |
| Smoking | – | Combination Product: Observational (registry)Non-interventional patient registry |
| Kidney Disease | – | Combination Product: Observational (registry)Non-interventional patient registry |
| Heart Diseases | – | Combination Product: Observational (registry)Non-interventional patient registry |
| Vascular diseases | – | Combination Product: Observational (registry)Non-interventional patient registry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Confirmed diagnosis of COVID-19 infection.
Key inclusion criteria (2 listed)
- Age ≥18 years (male or female)
- Patients admitted to any hospital center with a confirmed diagnosis of COVID-19 infection.
Key exclusion criteria (1 listed)
- Underage or not able to give informed consent
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 |
|---|---|---|
| Observational (registry)Observational (Patient Registry) | Combination product | Diabetes, Dyslipidemias, Elderly, Female, Heart Diseases, Hypertension, Kidney Disease, Male, Smoking, Vascular diseases |
Primary outcome
Death all cause
Time frame: 30-day
Occurrence of all cause death
Death all cause
Time frame: 6 month
Occurrence of all cause death
Death all cause
Time frame: 12-month
Occurrence of all cause death
10 secondary outcomes
Heart failure
Time frame: 30 day, 6 -12 months
Worsening renal function
Time frame: 30 day, 6 -12 months
Respiratory Insufficiency
Time frame: 30 day, 6 -12 months
Pneumonia
Time frame: 30 day, 6 -12 months
Sepsis
Time frame: 30 day, 6 -12 months
Systemic Inflammatory Response Syndrome (SIRS)
Time frame: 30 day, 6 -12 months
Thrombosis (arterial, venous)
Time frame: 30 day, 6 -12 months
Clinically relevant bleeding
Time frame: 30 day, 6 -12 months
Activity Daily Living status
Time frame: 30 day, 6 -12 months
Depression status
Time frame: 30 day, 6 -12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Background: PubMed 36651866Bugiardini 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.
- Derived from this study: PubMed 37449568Bergami 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.
- Individual participant dataSharing planned: Undecided
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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.
Olivia Manfrini, MD study director
University of Bologna
Lina Badimon, PhD study director
IR-Hospital de la Santa Creu i Sant Pau, UAB, Barcelona
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by University of Bologna at 2 sites in 2 countries.
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 2 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: looking for participants now, as of the sponsor's last update on 1 May 2026. 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 Italy, Spain. 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?
Contact Raffaele Bugiardini, MD (+39 051 347290, raffaele.bugiardini@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death all cause (time frame: 30-day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05188612, which also lists 2 linked publications.
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 1 May 2026.