key: cord-0791564-v6acv7zg authors: Sami, R.; Soltaninejad, F.; Amra, B.; Naderi, Z.; Haghjooy Javanmard, S.; Iraj, B.; Haji Ahmadi, S.; Shayganfar, A.; Dehghan, M.; Khademi, N.; Sadat Hosseini, N.; Mortazavi, M.; Mansourian, M.; Mananas, M. A.; Marateb, H. R.; Adibi, P. title: A one-year hospital-based prospective CVOID-19 open-cohort in the Eastern Mediterranean region: The Khorshid COVID Cohort (KCC) study date: 2020-05-15 journal: nan DOI: 10.1101/2020.05.11.20096727 sha: 057538f8bc913c16b816b21ccf91b2ce812429b3 doc_id: 791564 cord_uid: v6acv7zg The COVID-19 is rapidly scattering worldwide, and the number of cases in the Eastern Mediterranean Region is rising, there is a need for immediate targeted actions. We designed a longitudinal study in a hot outbreak zone to analyze the serial findings between infected patients for detecting temporal changes from February 2020. In a hospital-based open-cohort study, patients are followed from admission until one year from their discharge (the 1st, 4th, 12th weeks, and the first year). The measurements included demographic, socio-economics, symptoms, health service diagnosis and treatment, contact history, and psychological variables. The signs improvement, death, length of stay in hospital were considered as primary, and impaired pulmonary function and psychotic disorders were considered as main secondary outcomes. Notably, In the last two follow-ups, each patient attends the hospital to complete the Patient Health Questionnaire-9 (PHQ-9) and the Depression Anxiety Stress Scales (DASS-21). Moreover, clinical symptoms and respiratory functions are being determined in such follow-ups. Among the first 600 COVID-19 cases, a total of 490 patients with complete information (39% female; the average age of 57 {+/-} 15 years) were analyzed. Seven percent of these patients died. The three main leading causes of admission were: fever (77%), dry cough (73%), and fatigue (69%). The most prevalent comorbidities between COVID-19 patients were hypertension (35%), diabetes (28%), and ischemic heart disease (14%). The percentage of primary composite endpoints (PCEP), defined as death, the use of mechanical ventilation, or admission to an intensive care unit was 18%. The following comorbidities were significantly different in the positive and negative PCEP groups: acute kidney disease (p=0.008) and diabetes (p=0.026). For signs and symptoms, fatigue (p=0.020) and sore throat (p=0.001) were significantly different. This long-term prospective Cohort may support healthcare professionals in the management of resources following this pandemic. 3 designed a longitudinal study in a hot outbreak zone to analyze the serial findings between 50 infected patients for detecting temporal changes from February 2020. In a hospital-based 51 open-cohort study, patients are followed from admission until one year from their discharge 52 (the 1st, 4th, 12th weeks, and the first year). The measurements included demographic, 53 socio-economics, symptoms, health service diagnosis and treatment, contact history, and 54 psychological variables. The signs improvement, death, length of stay in hospital were 55 considered as primary, and impaired pulmonary function and psychotic disorders were 56 considered as main secondary outcomes. Notably, In the last two follow-ups, each patient 57 attends the hospital to complete the Patient Health Questionnaire-9 (PHQ-9) and the 58 Depression Anxiety Stress Scales (DASS-21). Moreover, clinical symptoms and respiratory 59 functions are being determined in such follow-ups. Among the first 600 COVID-19 cases, a 60 total of 490 patients with complete information (39% female; the average age of 57±15 61 years) were analyzed. Seven percent of these patients died. The three main leading causes 62 of admission were: fever (77%), dry cough (73%), and fatigue (69%). The most prevalent 63 In this prospective hospital-based surveillance study, patients who were admitted for 141 COVID-19 from February 2020 in the Khorshid Hospital in Isfahan were recruited. 142 Khorshid is the referral hospital for COVID-19 adults in Isfahan (Fig 2) . About fifty 143 percent of the entire CVOID-19 population from Isfahan refers to this hospital. 144 . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted May 15, 2020. protocol was also conformed to the Declaration of Helsinki. Also, the entire subjects gave 152 informed consent to the experimental procedure. The informed consent was given by the 153 first relative family of patients with severe conditions. This Cohort has two phases. The 154 first phase is on the admission information on hospitalized patients until discharge or death, 155 while the second phase is related to the patients who were discharged from the hospital for 156 future symptoms or social factors. Six-hundred patients were enrolled in the first phase, 157 while four-hundred ninety patients with complete information were analyzed in this paper. We obtained the information related to demographic, socioeconomic status (SES), 165 medical history, underlying chronic diseases, chest computed tomographic (CT) scans, 166 signs, symptoms, laboratory findings, treatment (including oxygen support, antibiotics, 167 antiviral therapy, corticosteroid therapy) during the hospital admission, and outcome data 168 . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted May 15, 2020. Have you had an influenza vaccine since September? . CC-BY-NC-ND 4.0 International license It is made available under a 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 May 15, 2020. . CC-BY-NC-ND 4.0 International license It is made available under a 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 May 15, 2020. Patients presenting the following criteria were discharged: per evaluation of the 200 treating physician, the clinical symptoms significantly improved (respiratory rate<20, pulse 201 rate<100, oxygen saturation of 92% while the patient was breathing ambient air), AND the 202 . CC-BY-NC-ND 4.0 International license It is made available under a 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 May 15, 2020. . https://doi.org/10.1101/2020.05.11.20096727 doi: medRxiv preprint body temperature to be returned to normal for more than two days without any antipyretic 203 medications, AND normal swallow for the solid oral medication (whole tablets and 204 capsules), AND passing until 14 days after the onset of symptoms for patients without 205 We used the self-report PHQ-9 questionnaire to measure the depression severity, 223 with the total scores labeled as the following: severe depression numbers two, four, seven, nine, fifteen, nineteen, and twenty. The anxiety subscale score 231 was also divided into five groups: extremely severe anxiety (20-42), severe anxiety (15-232 19), moderate anxiety (10-14), mild anxiety (7-9), and normal (0-6). The depression 233 subscale was formed using questions three, five, ten, thirteen, sixteen, seventeen, and 234 twenty-one. The total depression subscale score was classified as extremely severe 235 depression (28-42), severe depression (21-27), moderate depression (13-20), mild 236 depression (10-12), and normal (0-9). It was shown that the DASS is a reliable and valid 237 method in measuring mental health between the Iranian population [21] . Note that the 238 . CC-BY-NC-ND 4.0 International license It is made available under a 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 May 15, 2020. 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 May 15, 2020. . https://doi.org/10.1101/2020.05.11.20096727 doi: medRxiv preprint First, we entered the data into the Epi-Info 3.5.3 program 262 (https://www.cdc.gov/epiinfo/). Then, the data were analyzed using STATA v12.0 263 (StataCorp, College Station, TX). The patient characteristics were reported as a percentage 264 for categorical and mean (SD) for continuous data. The endpoint in this study was death or 265 cure from the entire COVID-19-related causes. We confirmed the endpoint by reviewing 266 hospital medical registration, or by calling using the registered phone number. When the 267 study period finishes, individuals alive after a follow-up time are censored. Accordingly, 268 the subject outcome variable is death or censored after the follow-ups. 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 May 15, 2020. . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted May 15, 2020. . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted May 15, 2020. . https://doi.org/10.1101/2020.05.11.20096727 doi: medRxiv preprint Prediction models for diagnosis and prognosis of covid-19 infection: systematic review and 417 critical appraisal Patients with COVID-19 Pneumonia: A Longitudinal Study Clinical features of patients infected with 422 2019 novel coronavirus in Wuhan Genomic characterisation and epidemiology 425 of 2019 novel coronavirus: implications for virus origins and receptor binding The psychological effects of quarantining a city Predictors of mortality for 430 patients with COVID-19 pneumonia caused by SARS-CoV-2: a prospective cohort study Epidemiology and transmission of COVID-433 19 in 391 cases and 1286 of their close contacts in Shenzhen, China: a retrospective cohort 434 study Interpreting COVID-19 and Virtual Care 436 Trends: Cohort Study Health Literacy 438 for Iranian Adults (HELIA): development and psychometric properties. Payesh (Health 439 . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted doi: medRxiv preprint Monitor) CDC COVID-19 Response Team. Update: Public Health Response to the 442 Outbreak -United States During Recovery From 2019 Novel Coronavirus (COVID-19) Pneumonia COVID-19. Endorsed by the Society of Thoracic Radiology, the American College of 450 Guidance for discharge and ending isolation in the context of widespread community 453 transmission of COVID-19 -first update Routine PHQ-9 depression screening in 458 home health care: depression, prevalence, clinical and treatment characteristics and screening 459 implementation Standardization of the depression screener patient health 461 questionnaire (PHQ-9) in the general population Multi-level predictors of 464 . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted doi: medRxiv preprint psychological problems among methadone maintenance treatment patients in difference types 465 of settings in Vietnam Validation of Depression Anxiety and Stress Scale (DASS-468 21) for an Iranian Population Wen Soon S. Psychosocial and coping responses 471 within the community health care setting towards a national outbreak of an infectious disease The impact of 474 community psychological responses on outbreak control for severe acute respiratory syndrome 475 in Hong Kong Coronavirus Disease 2019 in China Applied Survival Analysis Using R COVID-19 and mental health: A review of the existing literature Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Epidemiological and clinical 487 characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a 488 . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted doi: medRxiv preprint 26 descriptive study Clinical characteristics of novel 490 coronavirus cases in tertiary hospitals in Hubei Province A Review of Coronavirus Disease-2019 (COVID-19) SARS: prognosis, outcome 495 and sequelae Long-497 term outcomes of pandemic 2009 influenza A(H1N1)-associated severe ARDS Psychiatric Symptoms in Survivors 500 of Acute Respiratory Distress Syndrome. Effects of Age, Sex, and Immune Modulation The deadly coronaviruses: The 2003 503 SARS pandemic and the 2020 novel coronavirus epidemic in China )30460the author/funder, who has granted medRxiv a license to display the preprint in perpetuity Among 490 COVID-19 patients, 90 patients had positive PCEP. The following 296 characteristics were not significantly different in PCEP positive and negative groups: BMI, 297 occupation, marital status, number of infected family members, smoking status, and travel 298 history to the high-risk regions. However, the distribution of age (p<0.001), sex (p=0.010), 299 symptom duration (p=0.010), and quarantine before admission (p=0.0140) were 300 significantly different in PCEP positive and negative groups. Having analyzed the 301 comorbidities in PCEP positive and negative groups, although hypertension, Ischemic heart 302 disease, Immunological problems, COPD, and cancer were not significant, diabetes 303 (p=0.026), and acute kidney disease (p=0.008) were significant. 304 305 Among signs and vital symptoms, only SpO2 (p<0.001), fatigue (p=0.020), and 306Sore throat (p=0.001), and were significantly different in both groups. However, except for 307 Mg (p=0.500), and platelet count (p=0.051), other laboratory findings were significant in 308 the analyzed groups. Notably, elevated white blood cells (p<0.001), and neutrophil counts 309 (p<0.001), BUN (p=0.001), LDH (p<0.001), AST (p<0.001), ALT (p=0.002), ALP 310 (p=0.001), and Cr (p<0.001) were seen in PCEP positive groups compared with the 311 negative groups. However, the platelet counts decreased in the PCEP group, but it was not 312 significant (p=0.051). Moreover, the lymphocyte counts significantly decreased in the 313 PCEP positive class (p<0.001). 314 The median time from admission to discharge was 5.0 days (interquartile range 3.0-316 8.0). The transmission route was by a history of exposure to the epidemic area (16%) or 317 close contact with family members (25%), among which 10% of patients had both 318 exposures. The average symptom duration was 7.5 days. A significant reduction of this 319 time was observed in PCEP positive group respect to the negative group (p=0.010). 320 . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. contrast with other studies that reported that most of their patients had this problem [24, 29] . 342 343 Previous studies demonstrated that the elderly and those with underlying disorders 344 (i.e., cardiovascular diseases, diabetes, hypertension, and chronic obstructive pulmonary 345 . CC-BY-NC-ND 4.0 International license It is made available under a 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 May 15, 2020. . https://doi.org/10.1101/2020.05.11.20096727 doi: medRxiv preprint 20 disease) developed rapidly into ARDS, even leading to ICU admission or death [7] . 346Although our findings presented that the rate of death and ICU admission was 7% and 14%, 347 a similar condition was observed. Cardiac complications, including heart failure, 348 arrhythmia, or myocardial infarction, are common in patients with pneumonia. 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 May 15, 2020. preventive programs must be planned for such problems. It is of great importance when 379 considering the warning by the WHO chief as "the virus will be with us for a long time." 380 381 It must be mentioned that self-reporting used for the first two follow-ups has some 382 limitations in comparison with face-to-face interviews for the second and third follow-ups. 383Also, psychological studies do not necessarily probe psychological services efficacy. Thus, 384 dynamic observations and more follow-ups are necessary. The larger sample size is also 385 required for result verification, which is available during the Cohort. Apart from such 386 limitations, it is possible to perform a risk assessment and to use medical data mining for 387 diagnosis and prognosis to identify complex interactions. 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 May 15, 2020. CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)The copyright holder for this preprint this version posted May 15, 2020. . https://doi.org/10.1101/2020.05.11.20096727 doi: medRxiv preprintThe copyright holder for this preprint this version posted May 15, 2020. . https://doi.org/10.1101/2020.05.11.20096727 doi: medRxiv preprint 27 Supporting information 510 S1 File. The specification of the KCC based on STROBE Statement. 511 512 . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)The copyright holder for this preprint this version posted May 15, 2020. . https://doi.org/10.1101/2020.05.11.20096727 doi: medRxiv preprint