key: cord-0810388-16tghl48 authors: CONCHA-MEJIA, A.; RINCON-SANCHEZ, R. A. title: CCOFEE-GI Study: Colombian COVID19 First Experience in Gastroentrology. Characterization of digestive manifestations in patients diagnosed with COVID-19 at a highly complex institution in Bogota D.C., Colombia date: 2020-07-24 journal: nan DOI: 10.1101/2020.07.24.20161604 sha: d6e6d2ff323430edeaca07298cdd373b51d72d90 doc_id: 810388 cord_uid: 16tghl48 The current pandemic caused by SARS-CoV-2 has posed an important threat to the human health, healthcare systems, economy, and structure of societies. In Colombia, the first case was diagnosed on March 6, 2020 , with exponential progressive growth, and there were >200,000 confirmed cases as of July 20, 2020, in this cross-sectional, analytical, and observational study, we focused on the demographic, epidemiologic, and clinical characteristics of patients with confirmed SARS-CoV-2 infection at a highly complex institution in Latinamerica, with special emphasis on gastrointestinal symptoms. Methods: Demographic and clinical data were collected, results related to the outcomes such as hospitalization time, admission to ICU, need for orotracheal intubation, and death were also included. Statistical analyses were conducted using Stata software V.15. Results: We included 72 patients RT-PCR positive for SARS-CoV-2 (34 women and 38 men) with age 47.5 17.7 years; 17 (23.6%) presented at least one of the gastrointestinal symptoms (nausea/vomiting, abdominal pain, and/or diarrhea). 13 (76.47%) presented with diarrhea, 29.41% with nausea/vomiting, and five (29.41%) with abdominal pain. Diarrhea in 18.06% of all those infected with SARS-CoV-2 at the time of consultation, which was the most common digestive symptom. No significant differences were observed in requirement for endotracheal intubation, hospitalization, ICU admission, and fatal outcome between the NGIS and GIS groups (p:0.671, 0.483, 1,000, and 1,000). Conclusion: In our study, patients with gastrointestinal symptoms had no significant differences in disease severity, admission to ICU or death compared to those who did not have such symptoms. The current pandemic caused by severe acute respiratory syndrome 2 (SARS-CoV-2) has posed an important threat to the human health, healthcare systems, economy, and structure of societies. In Colombia, the first case was diagnosed on March 6, 2020 (1), with exponential progressive growth, and there were >200,000 confirmed cases as of July 20, 2020, almost 4 months later. The initially recognized manifestations include fever, myalgia, cough, and fatigue. The most frequently described radiological findings correspond to predominantly interstitial pneumonia (2, 3) . The presences of anosmia and dysgeusia have also been described as the likely neurological symptoms of SARS-CoV-2 infection (4) . This simple-chain RNA virus, a member of the family Coronaviridae, genus Betacoronavirus, has been found in rectal swabs and samples of fecal matter where they can remain for >30 days (5) , suggesting that the virus can infect the digestive tract and replicate there (3, 6) . Studies have reported digestive symptoms in patients with COVID-19 such as anorexia 39.7%-50.2%, diarrhea 2%-49.5%, nausea 1%-10.1%, vomiting 1%-15.9%, and abdominal pain 0.96%-6% (2, (7) (8) (9) (10) (11) (12) (13) . Digestive bleeding has also been reported in inflammatory diarrhea secondary to colitis due to SARS-CoV-2 (14, 15) . Patients with digestive symptoms have a long time from the onset of symptoms to admission to hospital services, and the presence of these gastrointestinal manifestations is associated with a longer duration and severity of the clinical presentation of COVID-19 (16) , with increased stay in the intensive care unit (10). Some medicines used to treat COVID-19 may generate digestive symptoms as side effects such as lopinavir/ritonavir that can cause diarrhea, nausea, and abdominal pain or tocilizumab that is associated with an increase in transaminase level (9,17). There is evidence for the expression of ACE2 and TMPRSS2 receptors in the gastrointestinal and hepatobiliary tracts, which may be a potential explanation for gastrointestinal and hepatic manifestations as well as a possible fecal-oral contamination route (2, 8, 9, 18, 19) . These findings allow us to broaden our understanding about the behavior of the virus in the digestive tract and its manifestations, development of preventive measures, and diagnostic and therapeutic strategies (3) . In this study, we focused on the demographic, epidemiologic, and clinical characteristics of patients with confirmed SARS-CoV-2 infection at a highly complex institution in Bogota, Colombia, with special emphasis on the presence of gastrointestinal symptoms. In this quantitative, cross-sectional, analytical, and observational study, we included 72 Table 1) . Demographic, clinical, and laboratory data were collected from the medical records by specialist physicians and were included in a database designed from a matrix of variables previously reviewed and approved by all authors. The nasopharyngeal swab samples obtained from all patients were transferred to viral medium and processed in laboratories authorized by the National Institute of Health of Colombia to confirm the presence of SARS-CoV-2 by RT-PCR and other viruses including influenza A and B; parainfluenza 1, 2, and 3; adenovirus; and respiratory syncytial virus. Demographic and clinical data were collected such as comorbidities, presence of respiratory and digestive symptoms at the time of admission, and laboratory results performed within the first 24 h. Results related to the outcome of the disease such as hospitalization time, requirement of admission to the intensive care unit, need for orotracheal intubation, and death were also included. For the description of patient characteristics and the variables in general, central trend (average) and dispersion (standard deviation) measures were used in quantitative variables, after comparing the normality in their distribution using Shapiro-Wilk test. If such a situation was not proven, they were described through median and interquartile ranges. Qualitative variables were described and analyzed using absolute frequencies and percentages. Quantitative variables between the groups were compared using the mean difference Z All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted July 24, 2020. . We included 72 patients with RT-PCR positive for SARS-CoV-2 (34 women and 38 men) with an average age of 47.5 ± 17.7 years; of these, 17 (23.6%) presented at least one of the gastrointestinal symptoms (nausea, vomiting, abdominal pain, and/or diarrhea). Of the 17 patients, 13 (76.47%) presented with diarrhea, five (29.41%) with nausea/vomiting, and five (29.41%) with abdominal pain (Table 2) The most common symptoms in both groups were fever, cough, dyspnea, and odynophagia, but there was no significant difference in their presentation between the GIS and NGIS groups as well as in the other less common presentations including anosmia, dysgeusia, sputum production, nasal congestion, and hemoptysis (Table 2) . Regarding respiratory compromise due to COVID-19 (Table 3) Upon comparing the requirement for endotracheal intubation, hospitalization, ICU admission, and fatal outcome between the NGIS and GIS groups, no significant differences were observed in their p-values (0.671, 0.483, 1,000, and 1,000, respectively; Table 4 ). Regarding the laboratory results, patients in the NGIS presented lower lymphocyte counts (p: 0.044) and higher levels of total bilirubin (p: 0.037) and lactate dehydrogenase (p: 0.014) All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted July 24, 2020. . https://doi.org/10.1101/2020.07.24.20161604 doi: medRxiv preprint than those in the SGI group (Table 5) . Despite the difference, the lymphocyte count and total bilirubin levels were within normal ranges in both groups. There was no significant difference in the other components of the blood count, renal function, liver enzymes, PCR, ferritin, or D-dimer. In this study, 23.6% showed some type of digestive symptom, predominantly diarrhea in 18.05% of the total, which is a finding consistent with several international reports such as patients. However, this symptom was not considered in the present study because it is not specifically related to digestive tract compromise. Although nausea and vomiting are independently described in a majority of international publications, in the present study, they were considered to be a single symptom because they usually occur together. Digestive bleeding has been described as a possible symptom of SARS-CoV-2 infection (14, 15) and has been reported in up to 13.7% patients with this condition (8) . It was not considered in the analysis of the present study given the significant influence of other external factors and those of patients such as the presence of coagulopathy, acid-peptic disease, use of NSAIDs, and presence of stress ulcers in patients requiring mechanical ventilation in the intensive care unit (which are not the focus of the present study). As a relevant finding in contrast to some previous studies, patients with gastrointestinal symptoms had no significant differences in terms of disease severity, admission to the intensive care unit, or death compared to those who did not have such symptoms. Although lymphocyte count results and LDH and bilirubin levels statistically differed, they were not clinically important because their values were within the normal range. in its clinical presentation and severity of its course. Digestive symptoms are part of the All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted July 24, 2020. . to suspect it in patients who, with a potential notion of contagion, present diarrhea, nausea/vomiting, or abdominal pain. The RT-PCR study for SARS-CoV-2 in fecal matter has not yet been standardized in Colombia. However, it would be an important diagnostic tool to identify especially respiratory asymptomatic patients with exclusively digestive symptoms, but with a great capacity for contagion, and thus contribute toward taking public health measures to slow down the rate of the spread of the disease. Further studies are required to improve the characterization of patients infected with SARS-CoV-2 in local institutions and thus to understand whether there are viral or host factors such as genetic or immunological differences that will allow the development of local strategies aimed at diagnosing and managing such cases. All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted July 24, 2020. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted July 24, 2020. . https://doi.org/10.1101/2020.07.24.20161604 doi: medRxiv preprint Colombian Consensus of Care, Diagnosis, and Management of SARS-CoV-2/COVID-19 Infection in Healthcare Establishments. Consensus-based Recommendations from Evidence-informed Experts Are Gastrointestinal Symptoms Specific for COVID-19 Infection? 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Epidemiologic Features and Clinical Course of Patients Infected with SARSCoV-2 in Singapore SARS-COV-2 Infection (Coronavirus Disease 2019) for the Gastrointestinal Consultant Single-cell RNA-seq Data Analysis on the Receptor ACE2 Expression Reveals the Potential Risk of Different Human Organs Vulnerable to 2019-nCoV Infection COVID-19: Gastrointestinal Manifestations and Potential Fecal-Oral Transmission Standard Deviation *Differences calculated using Wilcoxon sum of ranges **Differences calculated using Z test of mean difference This variable was available to 21 subjects with symptoms and 10 with no symptoms