Clinical Characteristics of Patients With SARS-CoV-2 (COVID-19) Infection in Guayaquil, Ecuador: COVID-EC Study

Design: Retrospective cohort study that will review the data of patients seen in participating centers with a confirmed or probable diagnosis of COVID-19 between March and April 2020. Those patients who test positive for nasopharyngeal exudate for SARS-CoV-2 will be considered a confirmed case using the real-time reverse transcriptase polymerase chain reaction (RT-PCR) technique. A patient with a severe acute respiratory infection (with fever and who needs to be hospitalized), and without another etiology that fully explains the clinical manifestations, and who has traveled to or resided in China in the 14 days prior to the onset of symptoms, or a patient with any acute respiratory illness and in whom at least one of the following conditions is met in the last 14 days prior to the onset of symptoms: having contact with a confirmed or probable case of infection with the COVID-19 virus, or having worked or been in a health care facility where patients with confirmed or probable infection with the COVID-19 virus were being treated, according to WHO criteria. Cases with nasopharyngeal exudate for SARS-CoV-2 negative are excluded from the study.

Ambit: Emergency, hospitalization and intensive care services at participating centers.

Subjects to study: Patients older than 18 years with a confirmed or suspected diagnosis of COVID-19 that required admission at participating centers.

Study variables:

• Demographic variables: Age, Sex, Personal history (hypertension, diabetes, previous cardiovascular disease, previous chronic lung disease, active smoking, obesity, etc.).
• Clinical variables: previous contact with a confirmed or suspected COVID-19 patient, days of onset of symptoms until the first consultation, symptoms (fever, asthenia / deterioration of general condition, cough, dyspnea, anosmia, ageusia, diarrhea, nausea, headache), signs present in the first recorded physical examination (blood pressure, saturation, temperature, heart rate, respiratory rate, auscultation, edema, weight and height).
• Laboratory variables: blood count, C-reactive protein (PCR), procalcitonin (PCT), lactate dehydrogenase (LDH), D-dimer, Ferritin, AST, ALT, GGT, Alkaline phosphatase, coagulation times, creatinine, urea, sodium, potassium . Arterial blood gas when available.
• Radiological variables: findings on plain radiography and chest computed tomography (CT).
• Microbiological variables: nasopharyngeal exudate for SARS-CoV-2, sputum culture, bronchoalveolar lavage, blood cultures, urine culture.
• Prognostic variables: need for hospitalization, length of hospital stay, need for admission to the Intensive Surveillance Unit (LVU), length of stay at LVU, need for invasive or non-invasive mechanical ventilation (MV), development of respiratory distress syndrome (ARDS), pneumonia, severity of pneumonia (CURB-65), sepsis (qSOFA), renal failure, electrolytic disturbances, stroke, ischemic heart disease, pulmonary embolism (PE) or deep vein thrombosis (DVT) and death.
• Therapeutic variables: treatment administered (Hydroxychloroquine, Chloroquine, Azithromycin, Lopinavir / Ritonavir, Oseltamivir, Tocilizumab, Corticosteroids, Ivermectin, Nitaxozanide, Enoxaparin or other low molecular weight heparin), dose administered, drug combination, time of administration, (counting the days from the onset of symptoms), registered adverse effects.