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| ID | Type | Description | Link |
|---|---|---|---|
| IN-US-983-6130 | Other Grant/Funding Number | Gilead Sciences |
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FUNCTION is an observational cohort study conducted by researchers from the Instituto de Medicina Tropical Alexander von Humboldt at Universidad Peruana Cayetano Heredia and Cayetano Heredia Hospital.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (asymptomatic infection) | Absence of clinical manifestation during the acute phase of SARS-CoV-2 infection until discharge. |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| None intervation | Other | Observational Study |
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| Measure | Description | Time Frame |
|---|---|---|
| Abnormal pulmonary function | % of participants with carbon monoxide diffusing capacity lower than 80 percent of predicted at each study visit. The dependent variable will be categorized as dichotomic variable for subsequent analysis | 6 months |
| Abnormal cardiovascular function | LVEF<50% will be considered an abnormal cardiovascular function test. The dependent variable will be categorized as dichomotoic variables for subsequent analysis. | 6 months |
| Abnormal quality of life | Health-related quality of life, Medical Outcomes Study short-form (SF-36) at each visit assessed using the Short Form-36 (SF-36). The SF-36 scale consists of 8 dimensions which is subsequently converted into a percentage score. The dependent variable will be categorized as dichotomic variable for subsequent analysis. | 6 months |
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Inclusion Criteria:
Individuals must meet all of the following criteria (either for group A or B) in order to participate in the study:
Exclusion Criteria:
An individual meeting any of the following criteria at the time of enrollment will be excluded from study participation:
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Inpatients will be screened and recruited mainly from Cayetano Heredia Hospital, a tertiary-level referral center with an assigned population of nearly 3 million individuals. Also patients admitted into different public or private institutions in Lima could be considered.
Outpatients will be screened and recruited from primary level health care centers located in different parts of Lima.
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| Name | Affiliation | Role |
|---|---|---|
| Rodrigo A Cachay, MD | Universidad Peruana Cayetano Heredia | Principal Investigator |
| Eduardo Gotuzzo, MD | Universidad Peruana Cayetano Heredia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia | Lima Lima | Lima | Peru |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33892403 | Background | 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. | |
| 28390872 | Background | 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. |
| Label | URL |
|---|---|
| Pericarditis and myocarditis long after SARS-CoV-2 infection: a cross-sectional descriptive study in health-care workers. Eiros R, et al. | View source |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D053120 | Respiratory Aspiration |
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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A total of 3 samples will be drawn at BL and M6 visits. Three mL of venous blood will be collected in EDTA tubes to calculate hemoglobin values using the SLS method. Four mL of venous blood will be collected in SST to calculate NT-ProBNP values using CLIA technique and the remaining serum will be stored in 1.8-ml cryovial at -70 Celsius degrees. Three mL of venous blood will be collected in EDTA tubes to separate plasma by centrifugation method and stored in 1.8-ml cryovial at -70 Celsius degrees. Plasma and serum will only be stored if it was previously authorized by the participant in the informed consent.
|
| 32172546 | Background | 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. |
| 33262076 | Background | 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. |
| 33068723 | Background | 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. |
| 34650349 | Background | 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. |
| 35132265 | Background | 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. |
| 33428867 | Background | 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. |
| 33273026 | Background | 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. |
| 33413976 | Background | 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. |
| 34011492 | Background | 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. |
| 37080629 | Derived | 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |