NCT05386485

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
162

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 7, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

August 30, 2022

Status Verified

May 1, 2022

Enrollment Period

1.2 years

First QC Date

May 9, 2022

Last Update Submit

August 28, 2022

Conditions

COVID-19

Keywords

COVID-19SARS-Cov-2Cardiovascular functionRespiratory functionLife qualityLong COVIDCOVID19 SequelaeFunction test

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (5)

Group A (asymptomatic infection)

Absence of clinical manifestation during the acute phase of SARS-CoV-2 infection until discharge.

Other: None intervation

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

Other: None intervation

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

Other: None intervation

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

Other: None intervation

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

Other: None intervation

Interventions

None intervationOTHER

Observational Study

Group A (asymptomatic infection)Group B1 (mild symptomatic infection)Group B2 (moderate symptomatic infection)Group B3 (severe symptomatic infection)Group B4 (critical symptomatic infection)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • Individuals must meet all of the following criteria (either for group A or B) in order to participate in the study:
  • 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

You may not qualify if:

  • An individual meeting any of the following criteria at the time of enrollment will be excluded from study participation:
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia

Lima Lima, Lima, Peru

Location

Related Publications (12)

  • 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.

    PMID: 33892403BACKGROUND

  • 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.

    PMID: 28390872BACKGROUND

  • 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.

    PMID: 32172546BACKGROUND

  • 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.

    PMID: 33262076BACKGROUND

  • 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.

    PMID: 33068723BACKGROUND

  • 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.

    PMID: 34650349BACKGROUND

  • 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.

    PMID: 35132265BACKGROUND

  • 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.

    PMID: 33428867BACKGROUND

  • 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.

    PMID: 33273026BACKGROUND

  • 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.

    PMID: 33413976BACKGROUND

  • 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.

    PMID: 34011492BACKGROUND

  • 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.

    PMID: 37080629DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

COVID-19Respiratory AspirationPost-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsPost-Infectious DisordersChronic DiseaseDisease Attributes

Study Officials

  • Rodrigo A Cachay, MD

    Universidad Peruana Cayetano Heredia

    PRINCIPAL INVESTIGATOR

  • Eduardo Gotuzzo, MD

    Universidad Peruana Cayetano Heredia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2022

First Posted

May 23, 2022

Study Start

August 7, 2021

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

August 30, 2022

Record last verified: 2022-05

Locations

PE(1)