IntroductionThe sequelae of COVID-19 have been described as a multisystemic condition, with a great impact on the cardiovascular and pulmonary systems with abnormalities in pulmonary function tests, such as lower diffusing capacity of the lung for carbon monoxide (DLco) levels and pathological patterns in spirometry; persistence of radiological lesions; cardiac involvement such as myocarditis and pericarditis; and an increase in mental disorders such as anxiety and depression. Several factors, such as infection severity during the acute phase as well as vaccination status, have shown some variable effects on these post-COVID-19 conditions, mainly at a clinical level such as symptoms persistence. Longitudinal assessments and reversibility of changes across the spectrum of disease severity are required to understand the long-term impact of COVID-19.Methods and analysisA prospective cohort study aims to assess the impact of SARS-CoV-2 infection on cardiopulmonary function and quality of life after the acute phase of the disease over a 6-month follow-up period. Sample size was calculated to recruit 200 participants with confirmatory COVID-19 tests who will be subsequently classified according to infection severity. Four follow-up visits at baseline, month 1, month 3 and month 6 after discharge from the acute phase of the infection will be scheduled as well as procedures such as spirometry, DLco test, 6-minute walk test, chest CT scan, echocardiogram, ECG, N-terminal pro-B-type natriuretic peptide measurement and RAND-36 scale. Primary outcomes are defined as abnormal pulmonary function test considered as DLco <80%, abnormal cardiovascular function considered as left ventricular ejection fraction <50% and abnormal quality of life considered as a <40 score for each sphere in the RAND-36-Item Short Form Health Survey.Ethics and disseminationThe study protocol was approved by the Institutional Ethics Committee of the Universidad Peruana Cayetano Heredia (SIDISI 203725) and the Ethics Committee of the Hospital Cayetano Heredia (042-2021). Protocol details were uploaded in ClinicalTrials.gov. Findings will be disseminated through peer-reviewed journals, scientific conferences and open-access social media platforms.Trial registration numberNCT05386485.
Background Longitudinal assessment and reversibility of changes in the pulmonary function tests in the post-acute phase of COVID-19 across the whole spectrum of severity of infection is needed to understand the long-term burden of the disease. Methods This was a prospective cohort of symptomatic patients with a positive SARS-CoV-2 (molecular or antigenic) test. Participants were divided based on infection severity at baseline as mildly-ill (B1), moderately-ill (B2), severely-ill (B3), critically-ill (B4) (Fig.1). Follow-up consisted of 4 visits: within 7 days from discharge (BL), and at months 1 (M1), 3 (M3), and 6(M6). We report findings up to M3 for participants enrolled August 2021- March 2022. Pulmonary function capacity was assessed with carbon monoxide diffusing capacity (DLCO), spirometry, and 6-minute walk test (6MWT). A DLCO< 80% was considered abnormal and reverted if >80% at follow-up visits. Study population divided by severity of infection Results Out of 206 eligible participants, 110 were enrolled, of which 96 (87%%), 79 (72%), and 52(47.2%) were evaluated at BL, M1, and M3, respectively (Fig.2). Most (67%) participants were male, median age was 37.5 years old (IQR: 28-46.3) and median body mass index was 26.7 (IQR:23.7-30.4). Regarding severity, 39 (41%) participants were classified as critically-ill (B4) at BL. No underlying comorbidities were reported among 63 (66%) participants, while diabetes type 2 (11%), asthma (7%) prior pulmonary tuberculosis (6%) and hypertension (5%) where the most frequent comorbidities overall; 17 (18%) reported smoking exposure. There were significant differences accross severity groups for sex, age, absence of comorbidities, and dyspnea during the acute phase of COVID-19 (Tab.1). At Of the 88 (92%) participants that underwent the pulmonary function tests at BL: 49 (56%) had DLCO < 80% with a tendency to revert across B1-B4 groups at month 3 (Fig.3). Spirometry parameters (Forced Vital Capacity, Forced Expiratory Volume 1, Peak Expiratory Flow) and distance walked on 6MWT were different across groups. Flowchart of the study population Demographics of study population stratified by groups of severity Median DLCO adjusted for hemoglobin value at baseline, month 1 and month 3 visits stratified by groups of severity of infection. Conclusion Abnormal DLCO tended to increase and revert to values greater than 80% in the 3-month follow-up period of patients recovered from SARS-CoV-2 infection across severity groups. Disclosures All Authors: No reported disclosures.
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