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COVID-19 Respiratory InfectionPHCNCT05067881

Post-COVID-19 Pneumo-hematocele

An observational study of COVID-19 Respiratory Infection, run by Hospital General Ajusco Medio at 1 site in Mexico.

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

Introduction. As the COVID-19 pandemic has continued, an increasing number of long-term complications are emerging. Recently, the appearance of characteristic pulmonary lesions has been noted, being described as post COVID-19 pneumatocele. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
COVID-19 Respiratory Infection
What is being tested?
Pulmonary resection
Type of treatment
Surgery or procedure
How many people
37 participants
Where
1 siteMexico
Study dates
1 Mar 2020to 20 Sep 2021
Phase
Observational
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with a positive chain reaction for SARS CoV-2 who had PHC on imaging studies in two hospitals of Mexico City

Who may be able to join

  • Adults with a positive protein chain reaction for SARS-CoV2,
  • PHC on imaging studies.

Who cannot join

  • loss of follow up
  • age out of range.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Karla Verónica Chávez Tostado

    Mexico City, 14500

Other trials in Mexico

About this study

Official title: Post COVID-19 Pneumo-hematocele: Clinical Presentation and Treatment Pathway

Introduction. As the COVID-19 pandemic has continued, an increasing number of long-term complications are emerging. Recently, the appearance of characteristic pulmonary lesions has been noted, being described as post COVID-19 pneumatocele. The aim of this study is to describe the clinical, histopathologic and imaging features of post COVID-19 pneumo-hematoceles (PHC) and secondarily to suggest a treatment algorithm in these patients.

Methods. A retrospective study was performed in patients admitted with diagnosis of SARS-CoV2 infection from March 2020 to September 2021 who presented PHC on imaging studies. Clinical and demographic variables were recorded and CT scans were analyzed. A logistic regression analysis was performed to determine the risk for rupture according to PHC characteristics.

It appears that PHC occurs secondary to encapsulation of blood accumulation, the result of micro capillary bleeding, with partial reabsorption of blood and subsequent air filling. The recommendation is to operate on patients with PHC of 5cm and those with persistent lesions of 3cm.

Being tested
Pulmonary resection
Keywords
COVID-19, Pneumohematocele, Giant bullae, Pneumatocele
Medical subject headings
COVID-19

What participants receive

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

  • Pulmonary resectionProcedure or surgery

    Resection of pneumohematocele

Study groups in NCT05067881
Study groupRoleWhat they receive
PneumohematocelePatients with SARS CoV-2 diagnosis and PHC on imaging studies
Receives: Procedure: Pulmonary resection

What is being measured

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

  1. PHC diagnosis

    Pneumohematoceles on imaging studies

    Measured: From date of diagnosis until 4 weeks after diagnosis

Timeline

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

  1. First posted5 Oct 2021
  2. Study start1 Mar 2020
  3. Primary completion1 Mar 2020
  4. Study completion20 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05067881
Sponsor's protocol ID
HGAM02
Acronym
PHC
Status last verified
Oct 2021
First submitted
28 Sep 2021
Last updated
5 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ho JS, Sia CH, Chan MY, Lin W, Wong RC. Coronavirus-induced myocarditis: A meta-summary of cases. Heart Lung. 2020 Nov-Dec;49(6):681-685. doi: 10.1016/j.hrtlng.2020.08.013. Epub 2020 Aug 20.

    PubMed 32861884

  • Inciardi RM, Lupi L, Zaccone G, Italia L, Raffo M, Tomasoni D, Cani DS, Cerini M, Farina D, Gavazzi E, Maroldi R, Adamo M, Ammirati E, Sinagra G, Lombardi CM, Metra M. Cardiac Involvement in a Patient With Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Jul 1;5(7):819-824. doi: 10.1001/jamacardio.2020.1096.

    PubMed 32219357

  • Chen X, Laurent S, Onur OA, Kleineberg NN, Fink GR, Schweitzer F, Warnke C. A systematic review of neurological symptoms and complications of COVID-19. J Neurol. 2021 Feb;268(2):392-402. doi: 10.1007/s00415-020-10067-3. Epub 2020 Jul 20.

    PubMed 32691236

  • Maury A, Lyoubi A, Peiffer-Smadja N, de Broucker T, Meppiel E. Neurological manifestations associated with SARS-CoV-2 and other coronaviruses: A narrative review for clinicians. Rev Neurol (Paris). 2021 Jan-Feb;177(1-2):51-64. doi: 10.1016/j.neurol.2020.10.001. Epub 2020 Dec 16.

    PubMed 33446327

  • Ojo AS, Balogun SA, Williams OT, Ojo OS. Pulmonary Fibrosis in COVID-19 Survivors: Predictive Factors and Risk Reduction Strategies. Pulm Med. 2020 Aug 10;2020:6175964. doi: 10.1155/2020/6175964. eCollection 2020.

    PubMed 32850151

  • Gentile F, Aimo A, Forfori F, Catapano G, Clemente A, Cademartiri F, Emdin M, Giannoni A. COVID-19 and risk of pulmonary fibrosis: the importance of planning ahead. Eur J Prev Cardiol. 2020 Sep;27(13):1442-1446. doi: 10.1177/2047487320932695. Epub 2020 Jun 17. No abstract available.

    PubMed 32551971

  • Sun R, Liu H, Wang X. Mediastinal Emphysema, Giant Bulla, and Pneumothorax Developed during the Course of COVID-19 Pneumonia. Korean J Radiol. 2020 May;21(5):541-544. doi: 10.3348/kjr.2020.0180. Epub 2020 Mar 20.

    PubMed 32207255

  • Sato L, Kinoshita N, Nakamoto T, Ohmagari N. Hemoptysis and a Newly Formed Lung Bulla in a Case of Convalescent COVID-19 Pneumonia. Intern Med. 2021 Mar 1;60(5):803-805. doi: 10.2169/internalmedicine.5684-20. Epub 2021 Jan 15.

    PubMed 33456035

  • Xu W, Luo X, Wang H, Shen C, Song Y, Sun T, Chen M. Pulmonary emphysema, bullae, and pneumothorax in COVID-19 pneumonia. Radiol Case Rep. 2021 May;16(5):995-998. doi: 10.1016/j.radcr.2021.01.055. Epub 2021 Jan 31.

    PubMed 33552325

  • Sanivarapu RR, Farraj K, Sayedy N, Anjum F. Rapidly developing large pneumatocele and spontaneous pneumothorax in SARS-CoV-2 infection. Respir Med Case Rep. 2020;31:101303. doi: 10.1016/j.rmcr.2020.101303. Epub 2020 Dec 2.

    PubMed 33294361

  • Hamad AM, El-Saka HA. Post COVID-19 large pneumatocele: clinical and pathological perspectives. Interact Cardiovasc Thorac Surg. 2021 Jul 26;33(2):322-324. doi: 10.1093/icvts/ivab072.

    PubMed 33764376

  • Sharma S, Kasi A. Pneumatocele. 2025 Jan 19. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK556146/

    PubMed 32310606

  • Desrues B, Delaval P, Motreff C, Kernec J, Dormoy C, Pencole C, Bergeron D, Malledan Y, Saint-Marc C. [Post-traumatic pneumatocele and hemato-pneumatocele of the lung. Apropos of 3 cases]. Rev Mal Respir. 1988;5(1):67-70. French.

    PubMed 3368637

  • Kaira K, Ishizuka T, Yanagitani N, Sunaga N, Hisada T, Mori M. Pulmonary traumatic pneumatocele and hematoma. Jpn J Radiol. 2009 Feb;27(2):100-2. doi: 10.1007/s11604-008-0296-x. Epub 2009 Mar 12.

    PubMed 19373539

  • Al-Ghafri M, Al-Hanshi S, Al-Ismaily S. Two Cases of Pneumatoceles in Mechanically Ventilated Infants. Oman Med J. 2015 Jul;30(4):299-302. doi: 10.5001/omj.2015.59.

    PubMed 26366266

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 Respiratory Infection, run by Hospital General Ajusco Medio at 1 site in Mexico.

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 2 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 5 Oct 2021. 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 Mexico. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

PHC diagnosis (time frame: From date of diagnosis until 4 weeks after diagnosis). 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 NCT05067881, which also lists 26 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 5 Oct 2021; AzTrials last refreshed its copy on 4 Nov 2026.

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