COVID-19NCT04794062

Myocardial Injury and Quality of Life After COVID-19

An observational study of COVID-19 and Myocardial Injury, run by Voronezh Regional Clinical Consultative and Diagnostic Center at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

In this observational study follow-up and dynamic observation will be conducted on the participants recovered from pneumonia caused by COVID-19. The main goal is an early diagnosis and detection of myocardial (heart) injury and quality of life in participants recovered from COVID-19 and follow-up in selected… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19, Myocardial Injury, Myocarditis Post Infection
How many people: 119 participants
Where: 1 siteRussia
Study dates: 16 Sep 2020to 31 Dec 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: Community population of the Voronezh region in Western Russia, without need of hospitalization, sent to by the primary care physicians.

Who may be able to join

Adult patients of age above 18 years with diagnosed SARS-CoV-2 infection based on the PCR (polymerase chain reaction) and/or quantitative tests of IgM and IgG antibodies in serum;
Pneumonia development confirmed by chest computed tomography;
Negative PCR test for SARS-CoV-2 at the time of inclusion into the study;
Stable patient state allowing outpatient follow-up;
Signed informed consent.

Who cannot join

Absence of convincing data confirming SARS-CoV-2 infection of a participant at the time of inclusion;
Absence of medical records regarding previous treatment of COVID-19;
Low compliance and unwillingness to undergo defined examinations;
Absence of informed consent.

Trial locations and contacts

1 site in 1 country.

Russia1 site

Voronezh Region Clinical, Consultative and Diagnostic Center
Voronezh, Voronezh Oblast, 394018

Other trials in Russia

About this study

Official title: Myocardial Injury and Quality of Life in Patients Recovered From the Pneumonia Associated With the Novel Coronavirus Infectious Disease COVID-19

Read the detailed description

The main goal of this observational non-interventional study is the evaluation of prevalence of myocardial injury (heart injury) of the participants recovered from the novel coronavirus infectious disease (COVID-19). Participants with signs of myocarditis (pericarditis) and/or myocardial fibrosis, and with a threat of heart failure development and other outcomes are selected into this study. In this cohort the percentage of participants having myocardial injury based on the level of high-sensitivity troponin, echocardiography (decreased Left Ventricle Ejection Fraction, abnormalities of wall motion, Right Ventricle dysfunction, increased size of heart chambers above referential values, presence of pericardial effusion), cardiac MRI with contrast enhancement (presence of edema on T2-weighted images, presence of early and late gadolinium enhancement phenomenon, local motion abnormalities, increased size of heart chambers above referential values, presence of pericardial effusion). At 6 months of the dynamic follow-up, MRI with contrast enhancement will be repeated in the participants with established myocardial injury at inclusion to assess the percentage of the participants having ongoing myocardial injury.

The secondary goal of the study is evaluation of quality of life of the patients recovered from the novel coronavirus infectious disease (COVID-19) by the means of EQ-5D and/or DASI questionnaire using the descriptive system of 5 components of quality of life related to the wellbeing, and visual analogue scale.

Conditions: COVID-19, Myocardial Injury, Myocarditis Post Infection
Keywords: COVID-9, myocardial injury, myocarditis
Medical subject headings: COVID-19, Myocarditis

What is being measured

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

Percentage of Patients (%) Recovered From COVID-19 With a Decrease in the Global Contractility of the Left and Right Ventricles.
Decrease of the left ventricle ejection fraction below 57% in men and women or decrease of the right ventricle ejection fraction below 52% in men and 51% in women.
Measured: Up to 12 months
Proportion of Patients (%) Recovered From COVID-19 With Signs of Pericardial Effusion.
Presence of pericardial effusion, i.e., presence of free echocardiographic spaces between the pericardial layers during diastole with pericardial layer thickness more than 4mm.
Measured: Up to 12 months
Proportion of Patients (%) Recovered From COVID-19 With Signs of Early and Late Gadolinium Enhancement of Myocardium.
Presence of early and late gadolinium enhancement of myocardium on cardiac MRI.
Measured: Up to 12 months

Timeline

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

16 Sep 202031 Dec 2021

First posted11 Mar 2021
Study start16 Sep 2020
Primary completion1 Oct 2021
Study completion31 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (29)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: Prospective
Enrolment: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04794062
Sponsor's protocol ID: 08092020
Status last verified: Nov 2024
First submitted: 15 Feb 2021
Last updated: 19 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Tavazzi G, Pellegrini C, Maurelli M, Belliato M, Sciutti F, Bottazzi A, Sepe PA, Resasco T, Camporotondo R, Bruno R, Baldanti F, Paolucci S, Pelenghi S, Iotti GA, Mojoli F, Arbustini E. Myocardial localization of coronavirus in COVID-19 cardiogenic shock. Eur J Heart Fail. 2020 May;22(5):911-915. doi: 10.1002/ejhf.1828. Epub 2020 Apr 11.
PubMed 32275347
Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
PubMed 32171076
Rudski L, Januzzi JL, Rigolin VH, Bohula EA, Blankstein R, Patel AR, Bucciarelli-Ducci C, Vorovich E, Mukherjee M, Rao SV, Beanlands R, Villines TC, Di Carli MF; Expert Panel From the ACC Cardiovascular Imaging Leadership Council. Multimodality Imaging in Evaluation of Cardiovascular Complications in Patients With COVID-19: JACC Scientific Expert Panel. J Am Coll Cardiol. 2020 Sep 15;76(11):1345-1357. doi: 10.1016/j.jacc.2020.06.080. Epub 2020 Jul 22.
PubMed 32710927
Lindner D, Fitzek A, Brauninger H, Aleshcheva G, Edler C, Meissner K, Scherschel K, Kirchhof P, Escher F, Schultheiss HP, Blankenberg S, Puschel K, Westermann D. Association of Cardiac Infection With SARS-CoV-2 in Confirmed COVID-19 Autopsy Cases. JAMA Cardiol. 2020 Nov 1;5(11):1281-1285. doi: 10.1001/jamacardio.2020.3551.
PubMed 32730555
Huang L, Zhao P, Tang D, Zhu T, Han R, Zhan C, Liu W, Zeng H, Tao Q, Xia L. Cardiac Involvement in Patients Recovered From COVID-2019 Identified Using Magnetic Resonance Imaging. JACC Cardiovasc Imaging. 2020 Nov;13(11):2330-2339. doi: 10.1016/j.jcmg.2020.05.004. Epub 2020 May 12.
PubMed 32763118
Puntmann VO, Carerj ML, Wieters I, Fahim M, Arendt C, Hoffmann J, Shchendrygina A, Escher F, Vasa-Nicotera M, Zeiher AM, Vehreschild M, Nagel E. Outcomes of Cardiovascular Magnetic Resonance Imaging in Patients Recently Recovered From Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Nov 1;5(11):1265-1273. doi: 10.1001/jamacardio.2020.3557.
PubMed 32730619
Hendren NS, Drazner MH, Bozkurt B, Cooper LT Jr. Description and Proposed Management of the Acute COVID-19 Cardiovascular Syndrome. Circulation. 2020 Jun 9;141(23):1903-1914. doi: 10.1161/CIRCULATIONAHA.120.047349. Epub 2020 Apr 16.
PubMed 32297796
Medical rehabilitation during the novel coronavirus 19 disease (COVID-19). Physical and rehabilitation medicine, medical rehabilitation. 2020;2(2):140-189. DOI: https://doi.org/10.36425/rehab34231
Temporary methodical recommendation "Prophylaxis, diagnosis, and treatment of the novel coronavirus 19 (COVID-19)", 9th Edition released on 10/26/2020
Schultz JC, Hilliard AA, Cooper LT Jr, Rihal CS. Diagnosis and treatment of viral myocarditis. Mayo Clin Proc. 2009 Nov;84(11):1001-9. doi: 10.1016/S0025-6196(11)60670-8.
PubMed 19880690
Friedrich MG, Sechtem U, Schulz-Menger J, Holmvang G, Alakija P, Cooper LT, White JA, Abdel-Aty H, Gutberlet M, Prasad S, Aletras A, Laissy JP, Paterson I, Filipchuk NG, Kumar A, Pauschinger M, Liu P; International Consensus Group on Cardiovascular Magnetic Resonance in Myocarditis. Cardiovascular magnetic resonance in myocarditis: A JACC White Paper. J Am Coll Cardiol. 2009 Apr 28;53(17):1475-87. doi: 10.1016/j.jacc.2009.02.007.
PubMed 19389557
Ferreira VM, Schulz-Menger J, Holmvang G, Kramer CM, Carbone I, Sechtem U, Kindermann I, Gutberlet M, Cooper LT, Liu P, Friedrich MG. Cardiovascular Magnetic Resonance in Nonischemic Myocardial Inflammation: Expert Recommendations. J Am Coll Cardiol. 2018 Dec 18;72(24):3158-3176. doi: 10.1016/j.jacc.2018.09.072.
PubMed 30545455
Caforio AL, Pankuweit S, Arbustini E, Basso C, Gimeno-Blanes J, Felix SB, Fu M, Helio T, Heymans S, Jahns R, Klingel K, Linhart A, Maisch B, McKenna W, Mogensen J, Pinto YM, Ristic A, Schultheiss HP, Seggewiss H, Tavazzi L, Thiene G, Yilmaz A, Charron P, Elliott PM; European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Current state of knowledge on aetiology, diagnosis, management, and therapy of myocarditis: a position statement of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Eur Heart J. 2013 Sep;34(33):2636-48, 2648a-2648d. doi: 10.1093/eurheartj/eht210. Epub 2013 Jul 3.
PubMed 23824828
Comparative investigation of informative yield of non-invasive diagnostics methods of inflammatory diseases of myocardium. Russian cardiology journal 2018, (154): 53-59. http://dx.doi.org/10.15829/1560-4071-2018-2-53-59
Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.
PubMed 27206819

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Myocardial Injury and Quality of Life in Patients Recovered From the Pneumonia Associated With the Novel Coronavirus Infectious Disease COVID-19
ClinicalTrials.gov ID: NCT04794062
Acronym / sponsor ID: 08092020
Conditions: COVID-19, Myocardial Injury, Myocarditis Post Infection
Keywords: COVID-9, myocardial injury, myocarditis
Study type: Observational
Recruitment status: Completed
Enrolment: 119 participants (actual)
Lead sponsor: Voronezh Regional Clinical Consultative and Diagnostic CenterResearch network
Collaborators: Voronezh State Medical University named after N.N. Burdenko, Charles University, Czech Republic
Study start: 16 Sep 2020 (actual)
Primary completion: 1 Oct 2021 (actual)
Study completion: 31 Dec 2021 (actual)
First posted: 11 Mar 2021 (actual)
Results: Posted 15 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Community population of the Voronezh region in Western Russia, without need of hospitalization, sent to by the primary care physicians.

Key inclusion criteria (5 listed)

Adult patients of age above 18 years with diagnosed SARS-CoV-2 infection based on the PCR (polymerase chain reaction) and/or quantitative tests of IgM and IgG antibodies in serum;
Pneumonia development confirmed by chest computed tomography;
Negative PCR test for SARS-CoV-2 at the time of inclusion into the study;
Stable patient state allowing outpatient follow-up;
Signed informed consent.

Key exclusion criteria (4 listed)

Absence of convincing data confirming SARS-CoV-2 infection of a participant at the time of inclusion;
Absence of medical records regarding previous treatment of COVID-19;
Low compliance and unwillingness to undergo defined examinations;
Absence of 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.

Primary outcome

Percentage of Patients (%) Recovered From COVID-19 With a Decrease in the Global Contractility of the Left and Right Ventricles.
Time frame: Up to 12 months
Decrease of the left ventricle ejection fraction below 57% in men and women or decrease of the right ventricle ejection fraction below 52% in men and 51% in women.
Proportion of Patients (%) Recovered From COVID-19 With Signs of Pericardial Effusion.
Time frame: Up to 12 months
Presence of pericardial effusion, i.e., presence of free echocardiographic spaces between the pericardial layers during diastole with pericardial layer thickness more than 4mm.
Proportion of Patients (%) Recovered From COVID-19 With Signs of Early and Late Gadolinium Enhancement of Myocardium.
Time frame: Up to 12 months
Presence of early and late gadolinium enhancement of myocardium on cardiac MRI.

Results and safety

Results posted to the registry on 15 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Recovered From COVID-19	119	106

Primary outcome: Percentage of Patients (%) Recovered From COVID-19 With a Decrease in the Global Contractility of the Left and Right Ventricles.

Time frame: Up to 12 months. Count of participants. Unit: Participants

Measure	Patients Recovered From COVID-19 n = 106
Decreased function of left ventricle	19
Decreased function of right ventricle	39
No decrease in left or right ventricle function	48

Primary outcome: Proportion of Patients (%) Recovered From COVID-19 With Signs of Pericardial Effusion.

Time frame: Up to 12 months. Count of participants. Unit: Participants

Measure	Patients Recovered From COVID-19 n = 106
Pericardial effusion	27
No pericardial effusion	79

Primary outcome: Proportion of Patients (%) Recovered From COVID-19 With Signs of Early and Late Gadolinium Enhancement of Myocardium.

Time frame: Up to 12 months. Count of participants. Unit: Participants

Measure	Patients Recovered From COVID-19 n = 106
Presence of early and late gadolinium enhancement of myocardium.	28
No early and late gadolinium enhancement of myocardium.	78

Adverse events

Time frame: through study completion, an average of 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Recovered From COVID-19	0 of 106 (0%)	0 of 106 (0%)	0 of 106

Limitations and caveats (from the sponsor): This was a single-center, non-comparative study. Despite simple inclusion criteria for the patients recovered from COVID-19, the results of the study do not completely exclude bias. This is a cross-sectional study, which makes it impractical to describe the natural evolution of the changes found after COVID-19. The relatively small sample size makes it more difficult to compare subgroups and may prevent the identification of factors associated with heart injury and other patterns.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32275347Tavazzi G, Pellegrini C, Maurelli M, Belliato M, Sciutti F, Bottazzi A, Sepe PA, Resasco T, Camporotondo R, Bruno R, Baldanti F, Paolucci S, Pelenghi S, Iotti GA, Mojoli F, Arbustini E. Myocardial localization of coronavirus in COVID-19 cardiogenic shock. Eur J Heart Fail. 2020 May;22(5):911-915. doi: 10.1002/ejhf.1828. Epub 2020 Apr 11.
Background: PubMed 32171076Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
Background: PubMed 32710927Rudski L, Januzzi JL, Rigolin VH, Bohula EA, Blankstein R, Patel AR, Bucciarelli-Ducci C, Vorovich E, Mukherjee M, Rao SV, Beanlands R, Villines TC, Di Carli MF; Expert Panel From the ACC Cardiovascular Imaging Leadership Council. Multimodality Imaging in Evaluation of Cardiovascular Complications in Patients With COVID-19: JACC Scientific Expert Panel. J Am Coll Cardiol. 2020 Sep 15;76(11):1345-1357. doi: 10.1016/j.jacc.2020.06.080. Epub 2020 Jul 22.
Background: PubMed 32730555Lindner D, Fitzek A, Brauninger H, Aleshcheva G, Edler C, Meissner K, Scherschel K, Kirchhof P, Escher F, Schultheiss HP, Blankenberg S, Puschel K, Westermann D. Association of Cardiac Infection With SARS-CoV-2 in Confirmed COVID-19 Autopsy Cases. JAMA Cardiol. 2020 Nov 1;5(11):1281-1285. doi: 10.1001/jamacardio.2020.3551.
Background: PubMed 32763118Huang L, Zhao P, Tang D, Zhu T, Han R, Zhan C, Liu W, Zeng H, Tao Q, Xia L. Cardiac Involvement in Patients Recovered From COVID-2019 Identified Using Magnetic Resonance Imaging. JACC Cardiovasc Imaging. 2020 Nov;13(11):2330-2339. doi: 10.1016/j.jcmg.2020.05.004. Epub 2020 May 12.
Background: PubMed 32730619Puntmann VO, Carerj ML, Wieters I, Fahim M, Arendt C, Hoffmann J, Shchendrygina A, Escher F, Vasa-Nicotera M, Zeiher AM, Vehreschild M, Nagel E. Outcomes of Cardiovascular Magnetic Resonance Imaging in Patients Recently Recovered From Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Nov 1;5(11):1265-1273. doi: 10.1001/jamacardio.2020.3557.
Background: PubMed 32297796Hendren NS, Drazner MH, Bozkurt B, Cooper LT Jr. Description and Proposed Management of the Acute COVID-19 Cardiovascular Syndrome. Circulation. 2020 Jun 9;141(23):1903-1914. doi: 10.1161/CIRCULATIONAHA.120.047349. Epub 2020 Apr 16.
BackgroundMedical rehabilitation during the novel coronavirus 19 disease (COVID-19). Physical and rehabilitation medicine, medical rehabilitation. 2020;2(2):140-189. DOI: https://doi.org/10.36425/rehab34231
BackgroundTemporary methodical recommendation "Prophylaxis, diagnosis, and treatment of the novel coronavirus 19 (COVID-19)", 9th Edition released on 10/26/2020
Background: PubMed 19880690Schultz JC, Hilliard AA, Cooper LT Jr, Rihal CS. Diagnosis and treatment of viral myocarditis. Mayo Clin Proc. 2009 Nov;84(11):1001-9. doi: 10.1016/S0025-6196(11)60670-8.
Background: PubMed 19389557Friedrich MG, Sechtem U, Schulz-Menger J, Holmvang G, Alakija P, Cooper LT, White JA, Abdel-Aty H, Gutberlet M, Prasad S, Aletras A, Laissy JP, Paterson I, Filipchuk NG, Kumar A, Pauschinger M, Liu P; International Consensus Group on Cardiovascular Magnetic Resonance in Myocarditis. Cardiovascular magnetic resonance in myocarditis: A JACC White Paper. J Am Coll Cardiol. 2009 Apr 28;53(17):1475-87. doi: 10.1016/j.jacc.2009.02.007.
Background: PubMed 30545455Ferreira VM, Schulz-Menger J, Holmvang G, Kramer CM, Carbone I, Sechtem U, Kindermann I, Gutberlet M, Cooper LT, Liu P, Friedrich MG. Cardiovascular Magnetic Resonance in Nonischemic Myocardial Inflammation: Expert Recommendations. J Am Coll Cardiol. 2018 Dec 18;72(24):3158-3176. doi: 10.1016/j.jacc.2018.09.072.
Manuscript published at a journal KardiologiaLink provided by the sponsor.

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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. This study is not recruiting at the moment.

Roman Khokhlov, MD principal investigator

Voronezh Regional Clinical Consultative and Diagnostic Center

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 COVID-19 and Myocardial Injury, run by Voronezh Regional Clinical Consultative and Diagnostic Center at 1 site in Russia.

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 5 inclusion and 4 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: finished, as of the sponsor's last update on 19 Nov 2024. 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 Russia. 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?

Yes. Results are posted in the registry (first posted 15 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Patients (%) Recovered From COVID-19 With a Decrease in the Global Contractility of the Left and Right Ventricles. (time frame: Up to 12 months). 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 NCT04794062, which also lists 29 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 19 Nov 2024.