Lung DiseasesNCT04442789
Sequelae of Sars-CoV-2 Infections
An observational study of Lung Diseases and Cardiac Disease, run by University of Giessen at 1 site in Germany.
Trial summary
By the end of 2019 a new coronavirus, named SARS-CoV-2, was discovered in patients with pneumonia in Wuhan, China. In the following weeks and months the virus spread globally, having a tremendous impact on global health and economy. To date, no vaccine or therapy is available. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Cardiac Disease, Inflammatory Reaction
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 20 May 2020to 31 Dec 2025
- 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
- Adult, Older adult
Study population: Adult patients that have been hospitalized due to Covid 19
Who may be able to join
- hospitalization due to Sars-CoV-2 infection
Who cannot join
- under 18 years of age
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Khodr Tello, MD contact
Germany1 site, 1 recruiting
- Recruiting
Department of Internal Medicine II, Universities of Giessen and Marburg Lung Center (UGMLC), member of the German Center for Lung Research (DZL), Justus-Liebig-University
Giessen, 35392
Ulrich Matt, MD, PhD, 0049064198558773, ulrich.matt@innere.med.uni-giessen.de
About this study
Official title: Long-term Sequelae of Severe Sars-CoV-2 Infections
By the end of 2019 a new coronavirus, named SARS-CoV-2, was discovered in patients with pneumonia in Wuhan, China. In the following weeks and months the virus spread globally, having a tremendous impact on global health and economy. To date, no vaccine or therapy is available. Severe courses of the infection not only affect the lungs, but also other organs like the heart, kidney, or liver. The lack of preexisting immunity might at least partially explain the affection of extra pulmonary organs not yet seen in infections due to other respiratory viruses. In this observational investigation the study group will follow up on patients that have been hospitalized due to a SARS-CoV-2 infection, and monitor sequelae in various organs, with an emphasis on the pulmo-cardiovascular system. Our that in some patients, organ damage will persist and require long-term medical care.
Read the detailed description
Coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 requires hospitalization in a significant amount of patients. The hospitalization rate and disease severity increases in the elderly and patients with comorbidities such as diabetes, arterial hypertension, lung pathologies and obesity (Garg et al.). Patients with severe infections have pneumonia, requiring prolonged invasive ventilation. Sequelae of longer periods of mechanical ventilation and reduction of quality of life after acute respiratory distress syndrome (ARDS) are described (Herridge et al., 2 references). Besides, SARS-CoV-2 can induce - without preexisting immunity - strong inflammatory reactions, which can affect various organs. COVID-19 specific complications like thromboembolic events, neurologic events, myocardial involvement, or liver damage are reported during the acute stage of the infection. The lung is affected even during less severe infections, and ground glass opacities can result in consolidations (Shi et al.). These changes were reported to persist after discharge (Mo et al.). Acute kidney failure occurs in critically ill patients in 20-40% (Richardson et al.), and 40% of patients admitted to the hospital had proteinuria (Cheng et al.). Myocardial damage is reported, and some patients even presented initially with chest tightness and palpitations before having fever or cough (Zheng et al.). Moreover, patients with COVID-19 have a higher risk of thromboembolic events (Klok et al., Llitjos et al). Typically these patients have a prolonged activated partial thromboplastin time (aPTT), and often antiphospholipid antibodies (Bowles et al.). The long-term consequences of the strong inflammatory response affecting various organs are currently unknown. We hypothesize that some patients will have transient or persistent sequelae requiring medical care. The study group will therefore clinically examine patients that were hospitalized due to COVID-19, and monitor pulmonary, and other organ functions for at least one year after symptom onset. The study group will thereby perform lung and cardial examinations, monitor nephrologic parameters and perform radiology. Pneumologic tests will include a lung function test, a spiroergometry, a 6-minute walking test, and a grip-force test. Cardiac examination will include an echocardiography, and an electrocardiogram. In case of of severe pneumonia, or deterioration in lung function, computer tomography of the lungs will be performed. Blood (and urine) tests will include kidney parameters, inflammatory markers, liver values, and coagulation tests. Additional examinations will be done on an individual basis if clinically indicated, e.g. lung biopsies in case of suspected interstitial fibrosis. Additionally patient samples, which were taken for diagnostic purposes (serum, PBMCs, biopsies) will be stored in the biobank of the German center for lung research (DZL). Clinical evaluation and testing will start 2 months after symptom onset and the last visit is scheduled 10 months later. Depending on the results and the needs of the individual patient additional testing will be conducted.
- Conditions
- Lung Diseases, Cardiac Disease, Inflammatory Reaction
- Medical subject headings
- Lung Diseases, Heart Diseases, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Sequelae after COVID-19
Identify organ dysfunction after SARS-CoV-2 infections
Measured: 12 months, extension if required
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start20 May 2020
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies 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
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442789
- Sponsor's protocol ID
- SECOV
- Status last verified
- Mar 2025
- First submitted
- 18 Jun 2020
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garg S, Kim L, Whitaker M, O'Halloran A, Cummings C, Holstein R, Prill M, Chai SJ, Kirley PD, Alden NB, Kawasaki B, Yousey-Hindes K, Niccolai L, Anderson EJ, Openo KP, Weigel A, Monroe ML, Ryan P, Henderson J, Kim S, Como-Sabetti K, Lynfield R, Sosin D, Torres S, Muse A, Bennett NM, Billing L, Sutton M, West N, Schaffner W, Talbot HK, Aquino C, George A, Budd A, Brammer L, Langley G, Hall AJ, Fry A. Hospitalization Rates and Characteristics of Patients Hospitalized with Laboratory-Confirmed Coronavirus Disease 2019 - COVID-NET, 14 States, March 1-30, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 17;69(15):458-464. doi: 10.15585/mmwr.mm6915e3.
PubMed 32298251Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450.
PubMed 12594312Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.
PubMed 21470008Shi H, Han X, Jiang N, Cao Y, Alwalid O, Gu J, Fan Y, Zheng C. Radiological findings from 81 patients with COVID-19 pneumonia in Wuhan, China: a descriptive study. Lancet Infect Dis. 2020 Apr;20(4):425-434. doi: 10.1016/S1473-3099(20)30086-4. Epub 2020 Feb 24.
PubMed 32105637Mo P, Xing Y, Xiao Y, Deng L, Zhao Q, Wang H, Xiong Y, Cheng Z, Gao S, Liang K, Luo M, Chen T, Song S, Ma Z, Chen X, Zheng R, Cao Q, Wang F, Zhang Y. Clinical Characteristics of Refractory Coronavirus Disease 2019 in Wuhan, China. Clin Infect Dis. 2021 Dec 6;73(11):e4208-e4213. doi: 10.1093/cid/ciaa270.
PubMed 32173725Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium; Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775.
PubMed 32320003Cheng Y, Luo R, Wang K, Zhang M, Wang Z, Dong L, Li J, Yao Y, Ge S, Xu G. Kidney disease is associated with in-hospital death of patients with COVID-19. Kidney Int. 2020 May;97(5):829-838. doi: 10.1016/j.kint.2020.03.005. Epub 2020 Mar 20.
PubMed 32247631Zheng YY, Ma YT, Zhang JY, Xie X. COVID-19 and the cardiovascular system. Nat Rev Cardiol. 2020 May;17(5):259-260. doi: 10.1038/s41569-020-0360-5.
PubMed 32139904Klok FA, Kruip MJHA, van der Meer NJM, Arbous MS, Gommers DAMPJ, Kant KM, Kaptein FHJ, van Paassen J, Stals MAM, Huisman MV, Endeman H. Incidence of thrombotic complications in critically ill ICU patients with COVID-19. Thromb Res. 2020 Jul;191:145-147. doi: 10.1016/j.thromres.2020.04.013. Epub 2020 Apr 10.
PubMed 32291094Bowles L, Platton S, Yartey N, Dave M, Lee K, Hart DP, MacDonald V, Green L, Sivapalaratnam S, Pasi KJ, MacCallum P. Lupus Anticoagulant and Abnormal Coagulation Tests in Patients with Covid-19. N Engl J Med. 2020 Jul 16;383(3):288-290. doi: 10.1056/NEJMc2013656. Epub 2020 May 5. No abstract available.
PubMed 32369280Kimmig LM, Rako ZA, Ziegler S, Richter MJ, G S AT, Roller F, Grimminger F, Vadasz I, Seeger W, Herold S, Tello K, Matt U. Long-term comprehensive cardiopulmonary phenotyping of COVID-19. Respir Res. 2022 Sep 21;23(1):263. doi: 10.1186/s12931-022-02173-9.
PubMed 36131349
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Sequelae of Severe Sars-CoV-2 Infections
- ClinicalTrials.gov ID
- NCT04442789
- Acronym / sponsor ID
- SECOV
- Conditions
- Lung Diseases, Cardiac Disease, Inflammatory Reaction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Jun 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.
By the end of 2019 a new coronavirus, named SARS-CoV-2, was discovered in patients with pneumonia in Wuhan, China. In the following weeks and months the virus spread globally, having a tremendous impact on global health and economy. To date, no vaccine or therapy is available. Severe courses of the infection not only affect the lungs, but also other organs like the heart, kidney, or liver. The lack of preexisting immunity might at least partially explain the affection of extra pulmonary organs not yet seen in infections due to other respiratory viruses. In this observational investigation the study group will follow up on patients that have been hospitalized due to a SARS-CoV-2 infection, and monitor sequelae in various organs, with an emphasis on the pulmo-cardiovascular system. Our that in some patients, organ damage will persist and require long-term medical care.
Detailed description
Coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 requires hospitalization in a significant amount of patients. The hospitalization rate and disease severity increases in the elderly and patients with comorbidities such as diabetes, arterial hypertension, lung pathologies and obesity (Garg et al.). Patients with severe infections have pneumonia, requiring prolonged invasive ventilation. Sequelae of longer periods of mechanical ventilation and reduction of quality of life after acute respiratory distress syndrome (ARDS) are described (Herridge et al., 2 references). Besides, SARS-CoV-2 can induce - without preexisting immunity - strong inflammatory reactions, which can affect various organs. COVID-19 specific complications like thromboembolic events, neurologic events, myocardial involvement, or liver damage are reported during the acute stage of the infection. The lung is affected even during less severe infections, and ground glass opacities can result in consolidations (Shi et al.). These changes were reported to persist after discharge (Mo et al.). Acute kidney failure occurs in critically ill patients in 20-40% (Richardson et al.), and 40% of patients admitted to the hospital had proteinuria (Cheng et al.). Myocardial damage is reported, and some patients even presented initially with chest tightness and palpitations before having fever or cough (Zheng et al.). Moreover, patients with COVID-19 have a higher risk of thromboembolic events (Klok et al., Llitjos et al). Typically these patients have a prolonged activated partial thromboplastin time (aPTT), and often antiphospholipid antibodies (Bowles et al.). The long-term consequences of the strong inflammatory response affecting various organs are currently unknown. We hypothesize that some patients will have transient or persistent sequelae requiring medical care. The study group will therefore clinically examine patients that were hospitalized due to COVID-19, and monitor pulmonary, and other organ functions for at least one year after symptom onset. The study group will thereby perform lung and cardial examinations, monitor nephrologic parameters and perform radiology. Pneumologic tests will include a lung function test, a spiroergometry, a 6-minute walking test, and a grip-force test. Cardiac examination will include an echocardiography, and an electrocardiogram. In case of of severe pneumonia, or deterioration in lung function, computer tomography of the lungs will be performed. Blood (and urine) tests will include kidney parameters, inflammatory markers, liver values, and coagulation tests. Additional examinations will be done on an individual basis if clinically indicated, e.g. lung biopsies in case of suspected interstitial fibrosis. Additionally patient samples, which were taken for diagnostic purposes (serum, PBMCs, biopsies) will be stored in the biobank of the German center for lung research (DZL). Clinical evaluation and testing will start 2 months after symptom onset and the last visit is scheduled 10 months later. Depending on the results and the needs of the individual patient additional testing will be conducted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients that have been hospitalized due to Covid 19
Key inclusion criteria (1 listed)
- hospitalization due to Sars-CoV-2 infection
Key exclusion criteria (1 listed)
- under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sequelae after COVID-19
Time frame: 12 months, extension if required
Identify organ dysfunction after SARS-CoV-2 infections
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 30 Mar 2025.
- Background: PubMed 32298251Garg S, Kim L, Whitaker M, O'Halloran A, Cummings C, Holstein R, Prill M, Chai SJ, Kirley PD, Alden NB, Kawasaki B, Yousey-Hindes K, Niccolai L, Anderson EJ, Openo KP, Weigel A, Monroe ML, Ryan P, Henderson J, Kim S, Como-Sabetti K, Lynfield R, Sosin D, Torres S, Muse A, Bennett NM, Billing L, Sutton M, West N, Schaffner W, Talbot HK, Aquino C, George A, Budd A, Brammer L, Langley G, Hall AJ, Fry A. Hospitalization Rates and Characteristics of Patients Hospitalized with Laboratory-Confirmed Coronavirus Disease 2019 - COVID-NET, 14 States, March 1-30, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 17;69(15):458-464. doi: 10.15585/mmwr.mm6915e3.
- Background: PubMed 12594312Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450.
- Background: PubMed 21470008Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.
- Background: PubMed 32105637Shi H, Han X, Jiang N, Cao Y, Alwalid O, Gu J, Fan Y, Zheng C. Radiological findings from 81 patients with COVID-19 pneumonia in Wuhan, China: a descriptive study. Lancet Infect Dis. 2020 Apr;20(4):425-434. doi: 10.1016/S1473-3099(20)30086-4. Epub 2020 Feb 24.
- Background: PubMed 32173725Mo P, Xing Y, Xiao Y, Deng L, Zhao Q, Wang H, Xiong Y, Cheng Z, Gao S, Liang K, Luo M, Chen T, Song S, Ma Z, Chen X, Zheng R, Cao Q, Wang F, Zhang Y. Clinical Characteristics of Refractory Coronavirus Disease 2019 in Wuhan, China. Clin Infect Dis. 2021 Dec 6;73(11):e4208-e4213. doi: 10.1093/cid/ciaa270.
- Background: PubMed 32320003Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium; Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775.
- Background: PubMed 32247631Cheng Y, Luo R, Wang K, Zhang M, Wang Z, Dong L, Li J, Yao Y, Ge S, Xu G. Kidney disease is associated with in-hospital death of patients with COVID-19. Kidney Int. 2020 May;97(5):829-838. doi: 10.1016/j.kint.2020.03.005. Epub 2020 Mar 20.
- Background: PubMed 32139904Zheng YY, Ma YT, Zhang JY, Xie X. COVID-19 and the cardiovascular system. Nat Rev Cardiol. 2020 May;17(5):259-260. doi: 10.1038/s41569-020-0360-5.
- Background: PubMed 32291094Klok FA, Kruip MJHA, van der Meer NJM, Arbous MS, Gommers DAMPJ, Kant KM, Kaptein FHJ, van Paassen J, Stals MAM, Huisman MV, Endeman H. Incidence of thrombotic complications in critically ill ICU patients with COVID-19. Thromb Res. 2020 Jul;191:145-147. doi: 10.1016/j.thromres.2020.04.013. Epub 2020 Apr 10.
- Background: PubMed 32369280Bowles L, Platton S, Yartey N, Dave M, Lee K, Hart DP, MacDonald V, Green L, Sivapalaratnam S, Pasi KJ, MacCallum P. Lupus Anticoagulant and Abnormal Coagulation Tests in Patients with Covid-19. N Engl J Med. 2020 Jul 16;383(3):288-290. doi: 10.1056/NEJMc2013656. Epub 2020 May 5. No abstract available.
- Derived from this study: PubMed 36131349Kimmig LM, Rako ZA, Ziegler S, Richter MJ, G S AT, Roller F, Grimminger F, Vadasz I, Seeger W, Herold S, Tello K, Matt U. Long-term comprehensive cardiopulmonary phenotyping of COVID-19. Respir Res. 2022 Sep 21;23(1):263. doi: 10.1186/s12931-022-02173-9.
- 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.
Khodr Tello, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases and Cardiac Disease, run by University of Giessen at 1 site in Germany.
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 1 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 30 Mar 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 Germany. 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 Ulrich Matt, MD, PhD (0049-(0)641-985-58773, ulrich.matt@innere.med.uni-giessen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sequelae after COVID-19 (time frame: 12 months, extension if required). 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 NCT04442789, which also lists 11 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 30 Mar 2025.