A one-year hospital-based prospective COVID-19 open-cohort in the Eastern Mediterranean region: The Khorshid COVID Cohort (KCC) study

The COVID-19 is rapidly scattering worldwide, and the number of cases in the Eastern Mediterranean Region is rising. Thus, 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 patient recruitment phase finished at the end of August 2020, and the follow-up continues by the end of August 2021. 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 primary, and impaired pulmonary function and psychotic disorders were considered main secondary outcomes. Moreover, clinical symptoms and respiratory functions are being determined in such follow-ups. Among the first 600 COVID-19 cases, 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 Cox Proportional-Hazards Model for PCEP indicated the following significant risk factors: Oxygen saturation < 80% (HR = 6.3; [CI 95%: 2.5,15.5]), lymphopenia (HR = 3.5; [CI 95%: 2.2,5.5]), Oxygen saturation 80%-90% (HR = 2.5; [CI 95%: 1.1,5.8]), and thrombocytopenia (HR = 1.6; [CI 95%: 1.1,2.5]). 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?

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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.

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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.

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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.

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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.

(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. . 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