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Objectives: To determine the efficacy of Hydroxychloroquine vs. Hydroxychloroquine + Nitazoxanide in reducing the need for invasive mechanical ventilatory support for patients with COVID-19. Hydroxychloroquine is currently being used in multiple trials with varying doses in an attempt to treat COVID-19. Nitazoxanide has powerful antiviral effects and proven efficacy against a range of viruses including SARS and MERS. Dual therapy by combining appropriate doses of these two medications with diverse activities against COVID-19 is expected to be better than monotherapy with hydroxychloroquine.Trial Design: This is a single centre, randomized, controlled, single blinded, 2 arm (ratio 1:1) parallel group trial.Participants: 86 COVID-19 positive patients that are being treated at the Health Institute of the State of Mexico (ISEM) in Toluca, State of Mexico will be recruited from May 14 to December 31, 2020.Inclusion Criteria: 1)Age older than 18 years.2)Hospitalised COVID-19 PCR test positive patients.3)Within the first 72 hours after performing the PCR test.4)Presence of risk factors for complications (at least one): over 60 years, history of diabetes mellitus, hypertension, and morbid obesity.Exclusion Criteria: 1)Patients with corrected QT interval (QTc) greater than 500ms at hospital admission.2)Patients who have inherent contraindications to each drug.3)Patients who are unable to consent.4)Patients who have previously received chloroquine.5)Patients already intubated. Elimination criteria: 1)Patients whose clinical follow-up is lost or who decide not to continue in the study INTERVENTION AND COMPARATOR: The two management alternatives will be: Control - Hydroxychloroquine 200 mg taken orally every 12 hours for 7 days. Dual therapy - Hydroxychloroquine 400 mg taken orally every 12 hours for two days and then 200 mg taken orally every 12 hours for four days + Nitazoxanide 500 mg orally every 6 hours taken with food, for seven days.Main Outcomes: Primary: Mechanical ventilation requirement assessed at one week. Percentage of COVID-19 positive patients who require mechanical ventilation . All patients will be monitored till hospital discharge or death.Randomisation: Patients will be randomly allocated using allocation papers and opaque sealed envelopes to either receive the placebo or the dual therapy intervention treatment in a 1:1 ratio until we have recruited the required number of patients for each group.Blinding (masking): Trial participants will be blinded.Numbers To Be Randomised (sample Size): 86 participants will be randomized to each group, with 43 in the control group and 43 in the dual therapy group.Trial Status: Protocol version: 2, recruitment will begin on May 14 until sample size is reached , with the analysis deadline of December 31st 2020.Trial Registration: ClinicalTrials.gov Identifier: NCT04341493. Date of trial registration: April 10, 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. [ABSTRACT FROM AUTHOR]

Background: One of the risk factors for getting seriously ill from COVID-19 and reaching high mortality rates is older age. Older age is also associated with comorbidities, which are risk factors for severe COVID-19 infection. Among the tools that have been evaluated to predict intensive care unit (ICU) admission and mortality is ABC-GOALScl. Aim: In the present study we validated the utility of ABC-GOALScl to predict in-hospital mortality in subjects over 60 years of age who were positive for SARS-CoV-2 virus at the moment of admission with the purpose of optimizing sanitary resources and offering personalized treatment for these patients. Methods: This was an observational, descriptive, transversal, non-interventional and retrospective study of subjects (≥ 60 years of age), hospitalized due to COVID-19 infection at a general hospital in northeastern Mexico. A logistical regression model was used for data analysis. Results: Two hundred forty-three subjects were included in the study, whom 145 (59.7%) passed away, while 98 (40.3%) were discharged. Average age was 71, and 57.6% were male. The prediction model ABC-GOALScl included sex, body mass index, Charlson comorbidity index, dyspnea, arterial pressure, respiratory frequency, SpFi coefficient (Saturation of oxygen/Fraction of inspired oxygen ratio), serum levels of glucose, albumin, and lactate dehydrogenase; all were measured at the moment of admission. The area under the curve for the scale with respect to the variable of discharge due to death was 0.73 (IC 95% = 0.662—0.792). Conclusion: The ABC-GOALScl scale to predict ICU admission in COVID-19 patients is also useful to predict in-hospital death in COVID-19 patients ≥ 60 years old. [ABSTRACT FROM AUTHOR]

Background: Covid-19 in Mexico is on the rise in different parts of the country. We aimed to study the symptoms and comorbidities that associate with this pandemic in 3 different regions of Mexico.Methods: We analyzed data from SARS-CoV-2 positive patients evaluated at healthcare centers and hospitals of Mexico (n = 1607) including Northwest Mexico (Sinaloa state), Southeast Mexico (Veracruz state) and West Mexico (Jalisco state) between March 1 and July 30, 2020. Mexico consists of a total population that exceeds 128 million. Demographics, comorbidities and clinical symptoms were collected. Statistical descriptive analysis and correlation analyses of symptoms, comorbidities and mortality were performed.Results: A total of 1607 hospitalized patients positive for COVID-19 across all 3 regions of Mexico were included. The average age was 54.6 years and 60.4% were male. A mortality rate of 33.1% was observed. The most common comorbidities were hypertension (43.2%), obesity (30.3%) and diabetes (31.4%). Hypertension was more frequent in West (45%), followed by Northwest (37%) and Southeast Mexico (29%). Obesity was around 30% in Northwest and West whereas an 18% was reported in Southeast. Diabetes was most common in West (34%) followed by Northwest (22%) and Southeast (13%). This might be related to the highest mortality rate in Northwest (31%) and West (37%) when compared to Southeast. Most common symptoms in our overall cohort were fever (80.8%), cough (79.8%), headache (66%), dyspnea (71.1%), myalgia (53.8%), joints pain (50.8%) and odynophagia (34.8%). Diarrhea was the main gastrointestinal (GI) symptom (21.3%), followed by abdominal pain (18%), and nausea/ vomiting (4.5%). Diarrhea and abdominal pain were more common in West (23.1 and 21%), followed by Southeast (17.8, and 9.8%) and Northwest (11.4 and 3.1%).Conclusion: Our study showed a high mortality rate likely related to high frequencies of comorbidities (hypertension, obesity and diabetes). Mortality was different across regions. These discrepancies might be related to the differences in the frequencies of comorbidities, and partially attributed to differences in socio-economic conditions and quality of care. Thus, our findings stress the need for improved strategies to get better outcomes in our population. [ABSTRACT FROM AUTHOR]