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BACKGROUNDPoint-of-care rapid tests to identify SARS-CoV-2 can be of great help because, in principle, they allow decisions to be made at the site of care for treatment, or for the separation of cohorts avoiding cross-infection, especially in emergency situations. METHODSA cross sectional study in adults requesting care in Emergency Rooms (ER), or the outpatient clinics of referral hospitals for COVID-19, to define the diagnostic characteristics of a rapid antigen test for SARS-CoV-2 (the Abbott Panbio) having as a gold standard the RT-PCR for SARS-CoV-2. Health personnel in a routine situation within an active pandemic in several cities of Mexico performed the tests. RESULTSA total of 1,069 participants with a mean age of 47 years (SD 16 years), 47% with a self-reported comorbidity, and an overall prevalence of a positive RT-PCR test of 45%, were recruited from eight hospitals in Mexico. Overall sensitivity of the Panbio test was 54.4% (95%CI 51-57) with a positive likelihood ratio of 35.7, a negative likelihood ratio of 0.46 and a Receiver-Operating Characteristics curve area of 0.77. Positivity for the rapid test depended strongly on an estimate of the viral load (Cycle threshold of RT-PCR, Ct), and the days of symptoms. With a Ct[≤]25, sensitivity of the rapid test was 0.82 (95%CI, 0.76-0.87). For patients during the first week of symptoms sensitivity was 69.6% (95%CI 66-73). On the other hand, specificity of the rapid test was above 97.8% in all groups. CONCLUSIONSThe Panbio rapid antigen test for SARS-CoV-2 has a good specificity, but due to low and heterogeneous sensitivity in real life, a negative test in a person with suggestive symptoms at a time of community transmission of SARS-CoV-2 requires confirmation with RT-PCR, and after the first week of symptoms, sensitivity decreases considerably.
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BACKGROUNDCurrently, therapeutic options for ambulatory COVID-19 patients are limited. OBJECTIVETo evaluate the safety, efficacy and effect of the intramuscular administration of polymerized type I collagen (PTIC) on hyperinflammation, oxygen saturation and symptom improvement in adult outpatients with symptomatic COVID-19. DESIGNDouble-blind, randomised, placebo-controlled clinical trial of PTIC vs placebo. SETTINGSingle Third-level hospital in Mexico City (Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran) PARTICIPANTSEighty-nine adult participants with a confirmed COVID-19 diagnosis and symptom onset within the 7 days preceding recruitment were included from August 31, 2020 to November 7, 2020 and followed for 12 weeks. Final date of follow-up was February 4, 2021. INTERVENTIONSPatients were randomly assigned to receive either 1.5 ml of PTIC intramuscularly every 12 h for 3 days and then every 24 h for 4 days (n=45), or matching placebo (n=44). MAIN OUTCOMES AND MEASURESThe primary outcome was a mean reduction of at least 50% in the level of IP-10 compared to baseline. The secondary outcomes were mean oxygen saturation [≥]92% while breathing ambient air and duration of symptoms. RESULTSOf 89 patients who were randomised, 87 (97.8%) were included in an intention-to-treat analysis; 37 (41.6%) were male and mean age was 48.5{+/-}14.0 years. The IP-10 levels decreased 75% in the PTIC group and 40% in the placebo group vs baseline. The comparison between treatment vs placebo was also statistically significant (P=0.0047). The IL-8 (44%, P=0.045), M-CSF (25%, P=0.041) and IL-1Ra (36%, P=0.05) levels were also decreased in the PTIC group vs baseline. Mean oxygen saturation [≥]92% was achieved by 40/44 (90%), 41/42 (98%) and 40/40 (100%) of participants that received PTIC at 8, 15 and 97 days of follow-up vs 29/43 (67%), 31/39 (80%) and 33/37 (89%) of patients treated with placebo (P=0.001). The unadjusted accelerated failure time model showed that patients treated with PTIC achieved the primary outcome 2.70-fold faster (P<0.0001) than placebo. In terms of risk, the group of patients treated with PTIC had a 63% lower risk of having a mean oxygen saturation <92% vs placebo (P<0.0001). Symptom duration in patients treated with PTIC was reduced by 6.1{+/-}3.2 days vs placebo. No differences in adverse effects were observed between the groups at 8, 15 and 97 days of follow-up. CONCLUSIONSIn this study, treatment with PTIC down-regulated IP-10, IL-8, M-CSF and IL-Ra levels, which could explain the PTIC effect on the higher proportion of patients with mean oxygen saturation readings [≥]92% and a shorter duration of symptoms as compared to patients treated with placebo. Although results are encouraging, larger randomised trials are needed. TRIAL REGISTRATIONClinicalTrials.gov Identifier: NCT04517162
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ObjectivesCOVID-19 pandemic poses a burden on hospital resources and intensive care unit (ICU) occupation. This study aimed to provide a scoring system that, assessed upon first-contact evaluation at the emergency department, predicts the need for ICU admission. MethodsWe prospectively assessed patients admitted to a COVID-19 reference center in Mexico City between March 16th and May 21st, and split them into development and validation cohorts. Patients were segregated into a group that required admission to ICU, and a group that never required ICU admission and was discharged from hospitalization. By logistic regression, we constructed predictive models for ICU admission, including clinical, laboratory, and imaging findings from the emergency department evaluation. The ABC-GOALS score was created by assigning values to the weighted odd ratios. The score was compared to other COVID-19 and pneumonia scores through the area under the curve (AUC). ResultsWe included 569 patients divided into development (n=329) and validation (n=240) cohorts. One-hundred-fifteen patients from each cohort required admission to ICU. The clinical model (ABC-GOALSc) included sex, obesity, the Charlson comorbidity index, dyspnea, arterial pressure, and respiratory rate at triage evaluation. The clinical plus laboratory model (ABC-GOALScl) added serum albumin, glucose, lactate dehydrogenase, and S/F ratio to the clinical model. The model that included imaging (ABC-GOALSclx) added the CT scan finding of >50% lung involvement. The model AUC were 0.79 (95%CI 0.74-0.83) and 0.77 (95%CI 0.71-0.83), 0.86 (95%CI 0.82-0.90) and 0.87 (95%CI 0.83-0.92), 0.88 (95%CI 0.84-0.92) and 0.86 (95%CI 0.81-0.90) for the clinical, laboratory and imaging models in the development and validation cohorts, respectively. The ABC-GOALScl and ABC-GOALSclx scores outperformed other COVID-19 and pneumonia-specific scores. ConclusionThe ABC-GOALS score is a tool to evaluate patients with COVID-19 at admission to the emergency department, which allows to timely predict their risk of admission to an ICU.
