Long-term Impact on Cardiopulmonary Function and Quality of Life in Patients Recovered From COVID-19.
NCT ID: NCT05386485
Last Updated: 2022-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
162 participants
OBSERVATIONAL
2021-08-07
2022-10-31
Brief Summary
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The overall aim is to asses the long-term impact of SARS-CoV-2 infection on the cardiopulmonary function and quality of life in patients recovered from COVID-19, through a 6-month follow-up structured in 4 visits with clinical assessments and imaging studies performed by specialists.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group A (asymptomatic infection)
Absence of clinical manifestation during the acute phase of SARS-CoV-2 infection until discharge.
None intervation
Observational Study
Group B1 (mild symptomatic infection)
Clinical manifestation of the infection without severity signs (respiratory rate \< 30/minute; peripheral oxygen saturation (SpO2) \>94%) and no radiological evidence of pneumonia
None intervation
Observational Study
Group B2 (moderate symptomatic infection)
Clinical manifestation of the infection without severity signs (respiratory rate \< 30/minute; peripheral oxygen saturation (SpO2) \>94%) and radiological evidence of pneumonia
None intervation
Observational Study
Group B3 (severe symptomatic infection)
Clinical manifestation of the infection with severity signs (respiratory rate \> 30/minute; peripheral oxygen saturation (SpO2) \<94%) and radiological evidence of pneumonia
None intervation
Observational Study
Group B4 (critical symptomatic infection)
Clinical manifestation of the infection with severity signs (respiratory rate \> 30/minute; peripheral oxygen saturation (SpO2) \<94%) and at least one of the following:
I) Acute Respiratory Distress Syndrome: defined under Berlin Criteria mostly defined by a PaFi\<200, II) Shock: Patient diagnosed with sepsis that despite adequate fluid resuscitation, require vasopressors to maintain a mean arterial pressure ≥65 mmHg and lactate values \>2 mmol/L (\>18 mg/dL) or III) Organ dysfunction that requires ICU admission
None intervation
Observational Study
Interventions
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None intervation
Observational Study
Eligibility Criteria
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Inclusion Criteria
* Individuals of any sex over 18 years of age
* A positive COVID-19 test result by nasopharyngeal swab for either RT-PCR or antigenic techniques within the last 14 days prior the enrollment. A laboratory-based confirmatory report will be required
* Recruitment time close around the discharge date or no longer than 7 days after discharge
* Group A: Individuals who had not reported signs or symptoms suggestive of COVID-19 infection
* Group B: Individuals who had reported signs or symptoms suggestive of COVID-19 infection
Exclusion Criteria
* A negative COVID-19 test result by nasopharyngeal swab for either RT-PCR or antigenic techniques
* Known inability to keep adherent to the study (ex. incarceration, migration, travel)
* Active pregnancy confirmed by either qualitative urine or quantitative blood beta-hCG test
18 Years
ALL
No
Sponsors
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Universidad Peruana Cayetano Heredia
OTHER
Responsible Party
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Principal Investigators
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Rodrigo A Cachay, MD
Role: PRINCIPAL_INVESTIGATOR
Universidad Peruana Cayetano Heredia
Eduardo Gotuzzo, MD
Role: PRINCIPAL_INVESTIGATOR
Universidad Peruana Cayetano Heredia
Locations
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Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia
Lima Lima, Lima, Peru
Countries
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References
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Raveendran AV, Jayadevan R, Sashidharan S. Long COVID: An overview. Diabetes Metab Syndr. 2021 May-Jun;15(3):869-875. doi: 10.1016/j.dsx.2021.04.007. Epub 2021 Apr 20.
Venkataraman T, Frieman MB. The role of epidermal growth factor receptor (EGFR) signaling in SARS coronavirus-induced pulmonary fibrosis. Antiviral Res. 2017 Jul;143:142-150. doi: 10.1016/j.antiviral.2017.03.022. Epub 2017 Apr 5.
Yao XH, Li TY, He ZC, Ping YF, Liu HW, Yu SC, Mou HM, Wang LH, Zhang HR, Fu WJ, Luo T, Liu F, Guo QN, Chen C, Xiao HL, Guo HT, Lin S, Xiang DF, Shi Y, Pan GQ, Li QR, Huang X, Cui Y, Liu XZ, Tang W, Pan PF, Huang XQ, Ding YQ, Bian XW. [A pathological report of three COVID-19 cases by minimal invasive autopsies]. Zhonghua Bing Li Xue Za Zhi. 2020 May 8;49(5):411-417. doi: 10.3760/cma.j.cn112151-20200312-00193. Chinese.
Torres-Castro R, Vasconcello-Castillo L, Alsina-Restoy X, Solis-Navarro L, Burgos F, Puppo H, Vilaro J. Respiratory function in patients post-infection by COVID-19: a systematic review and meta-analysis. Pulmonology. 2021 Jul-Aug;27(4):328-337. doi: 10.1016/j.pulmoe.2020.10.013. Epub 2020 Nov 25.
Siddiqi HK, Libby P, Ridker PM. COVID-19 - A vascular disease. Trends Cardiovasc Med. 2021 Jan;31(1):1-5. doi: 10.1016/j.tcm.2020.10.005. Epub 2020 Oct 14.
Di Toro A, Bozzani A, Tavazzi G, Urtis M, Giuliani L, Pizzoccheri R, Aliberti F, Fergnani V, Arbustini E. Long COVID: long-term effects? Eur Heart J Suppl. 2021 Oct 8;23(Suppl E):E1-E5. doi: 10.1093/eurheartj/suab080. eCollection 2021 Oct.
Xie Y, Xu E, Bowe B, Al-Aly Z. Long-term cardiovascular outcomes of COVID-19. Nat Med. 2022 Mar;28(3):583-590. doi: 10.1038/s41591-022-01689-3. Epub 2022 Feb 7.
Huang C, Huang L, Wang Y, Li X, Ren L, Gu X, Kang L, Guo L, Liu M, Zhou X, Luo J, Huang Z, Tu S, Zhao Y, Chen L, Xu D, Li Y, Li C, Peng L, Li Y, Xie W, Cui D, Shang L, Fan G, Xu J, Wang G, Wang Y, Zhong J, Wang C, Wang J, Zhang D, Cao B. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study. Lancet. 2021 Jan 16;397(10270):220-232. doi: 10.1016/S0140-6736(20)32656-8. Epub 2021 Jan 8.
Arnold DT, Hamilton FW, Milne A, Morley AJ, Viner J, Attwood M, Noel A, Gunning S, Hatrick J, Hamilton S, Elvers KT, Hyams C, Bibby A, Moran E, Adamali HI, Dodd JW, Maskell NA, Barratt SL. Patient outcomes after hospitalisation with COVID-19 and implications for follow-up: results from a prospective UK cohort. Thorax. 2021 Apr;76(4):399-401. doi: 10.1136/thoraxjnl-2020-216086. Epub 2020 Dec 3.
Taboada M, Moreno E, Carinena A, Rey T, Pita-Romero R, Leal S, Sanduende Y, Rodriguez A, Nieto C, Vilas E, Ochoa M, Cid M, Seoane-Pillado T. Quality of life, functional status, and persistent symptoms after intensive care of COVID-19 patients. Br J Anaesth. 2021 Mar;126(3):e110-e113. doi: 10.1016/j.bja.2020.12.007. Epub 2020 Dec 10. No abstract available.
Daugherty SE, Guo Y, Heath K, Dasmarinas MC, Jubilo KG, Samranvedhya J, Lipsitch M, Cohen K. Risk of clinical sequelae after the acute phase of SARS-CoV-2 infection: retrospective cohort study. BMJ. 2021 May 19;373:n1098. doi: 10.1136/bmj.n1098.
Cachay R, Watanabe-Tejada T, Cuno K, Gil-Zacarias M, Coombes C, Ballena I, Mejia F, Medina F, Gayoso O, Seas C, Otero L, Gotuzzo E. Long-term impact on cardiopulmonary function and quality of life among patients recovered from SARS-CoV-2 infection in a 6-month follow-up period in Lima, Peru: FUNCTION cohort study protocol. BMJ Open. 2023 Apr 20;13(4):e067365. doi: 10.1136/bmjopen-2022-067365.
Related Links
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Pericarditis and myocarditis long after SARS-CoV-2 infection: a cross-sectional descriptive study in health-care workers. Eiros R, et al.
Other Identifiers
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IN-US-983-6130
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SIDISI 203725
Identifier Type: -
Identifier Source: org_study_id
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