Regional moderate hyperthermia for mild-to-moderate COVID-19 (TherMoCoV study): a randomized controlled trial.

Background: To prevent COVID-19 progression, low-cost alternatives that are available to all patients are needed. Diverse forms of thermotherapy have been proposed to prevent progression to severe/critical COVID-19. Objective: The aim of this study is to evaluate the efficacy and safety of local thermotherapy to prevent disease progression in hospitalized adult patients with mild-to-moderate COVID-19. Methods: A multicenter, open-label, parallel-group, randomized, adaptive trial is used to evaluate the efficacy and safety of local thermotherapy to prevent disease progression in hospitalized adult patients with mild-to-moderate COVID-19. Eligible hospitalized adult patients with symptoms of COVID-19 with ≤5 days from symptom onset, meeting criteria for mild or moderate COVID-19, were randomly assigned to the intervention consisting of local thermotherapy via an electric heat pad in the thorax (target temperature range 39.5­42°C) continuously for 90 min, twice daily, for 5 days, or standard care. The main outcome was the proportion of patients who progressed to severe-to-critical COVID-19 or death. Patients were randomized in a 1:1 ratio through a centralized computer-generated sequence of minimization with a random component of 20%. Participants and medical staff were not blinded to the intervention. Results: One-hundred and five participants (thermotherapy n = 54, control n = 51) with a median age of 53 (IQR: 41­64) years were included for analysis after the early cessation of recruitment due to the closure of all temporal COVID-19 units (target sample size = 274). The primary outcome of disease progression occurred in 31.4% (16/51) of patients in the control group vs. 25.9% (14/54) of those receiving thermotherapy (risk difference = 5.5%; 95%CI: −11.8­22.7, p = 0.54). Thermotherapy was well tolerated with a median total duration of thermotherapy of 900 (IQR: 877.5­900) min. Seven (13.7%) patients in the control group and seven (12.9%) in the thermotherapy group had at least one AE (p = 0.9), none of which were causally attributed to the intervention. No statistically significant differences in serum cytokines (IL-1ß, IL-6, IL-8, IL-10, IL-17, and IFN-γ) were observed between day 5 and baseline among groups. Conclusion: Local thermotherapy was safe and well-tolerated. A non-statistically significant lower proportion of patients who experienced disease progression was found in the thermotherapy group compared to standard care. Local thermotherapy could be further studied as a strategy to prevent disease progression in ambulatory settings.Clinical Trial registration: www.clinicaltrials.gov, identifier: NCT04363541.

[Prosopis spp. in allergic diseases]. / Prosopis spp. en enfermedades alérgicas.

OBJECTIVES: To demonstrate cutaneous reactivity and the participation of Prosopis pollen in patients with allergic diseases who attend the Allergy and Clinical Immunology Service of the General Hospital of Mexico, in Mexico City. METHODS: A retrospective and cross-sectional study was carried out by analyzing clinical records that had a complete medical history of patients between the ages of 3 and 79 years, with diagnoses of allergic rhinitis, asthma, and rhinoconjunctivitis. RESULTS: 1285 patients were studied; the frequency of positive skin reactivity for Prosopis was 27.78 %; 82.97 % had a diagnosis of allergic rhinitis, 4.39 % had a diagnosis of asthma, and 12.64 % had a diagnosis of rhinoconjunctivitis. CONCLUSIONS: Prosopis pollen plays an important role in diseases of allergic etiology. It is important to consider the antigenic combination with other families such as Chenopodiaceae.

Objetivos: Demostrar la reactividad cutánea y la participación del polen de Prosopis en los pacientes con enfermedades alérgicas que acuden al Servicio de Alergia e Inmunología Clínica del Hospital General de México, en la Ciudad de México. Métodos: Se llevó a cabo un estudio retrospectivo y transversal de expedientes clínicos que contaran con historia clínica completa, de pacientes entre tres y 79 años de edad con diagnósticos de rinitis, asma y rinoconjuntivitis alérgica. Resultados: Se estudiaron 1285 pacientes. La frecuencia de reactividad cutánea positiva para Prosopis fue de 27.78 %; 82.97 % cursaba con diagnóstico de rinitis alérgica, 4.39 % de asma y 12.64 % de rinoconjuntivitis. Conclusión: El polen de Prosopis participa importantemente en enfermedades de etiología alérgica. Es importante considerar el cruce antigénico con otras familias como las Chenopodiaceas.

Identification of an allergenic calmodulin from Amaranthus palmeri pollen.

INTRODUCTION: Pollens are an important source of allergens that trigger rhinitis or asthma. The allergenic extracts of pollens used to diagnose and treat allergies contain different allergenic antigens. Isolated allergenic proteins are employed in in vitro assays, skin tests and allergenic-specific immunotherapy. Calcium-binding allergens are clinically relevant antigens, and their allergenicity can be affected by Ca2+ binding. In this work, a calmodulin was identified as an allergen from Amaranthus palmeri pollen, an important source of pollinosis in Europe, Asia and North America. MATERIALS AND METHODS: Allergenic calmodulin from A. palmeri pollen was isolated by size-exclusion chromatography and reverse-phase chromatography and identified by mass spectrometry. Sensitization to isolated calmodulin was evaluated by skin prick tests in patients with allergy to A. palmeri pollen. RESULTS: Size-exclusion chromatography yielded two fractions that were recognized by the IgE of patients allergic to A. palmeri pollen. Mass spectrometry analysis of the fractions from reverse-phase chromatography showed peptide sequences that identified a calmodulin. Skin prick tests showed that the isolated calmodulin was recognized by 56% of patients allergic to A. palmeri pollen. CONCLUSION: A. palmeri pollen calmodulin could be a clinically relevant allergen in patients sensitized to this source.

[Sensitization to Casuarina equisetifolia and Pinus spp pollen in patients with allergic rhinitis and asthma in Mexico City]. / Sensibilización al polen de Casuarina equisetifolia y Pinus spp en pacientes con rinitis alérgica y asma en la Ciudad de México.

BACKGROUND: Pollinosis studies at Mexico City have found a considerable amount of Casuarina equisetifolia and Pinus spp pollen, its sensitization frequency is unknown. In Mexico, some allergens are not considered related to asthma or allergic rhinitis, even though reports in other countries have been demonstrated their relevance as aeroallergens. OBJECTIVE: To estimate the frequency of sensitization to Casuarina equisetifolia and Pinus spp pollen. PATIENTS AND METHOD: A transversal, descriptive trial was done at Hospital General de Mexico. Previous informed consent 142 patients with allergic rhinitis and asthma, 3 to 55 years old, were included to the study. A complete clinical evaluation, laboratory tests and skin prick tests were performed. RESULTS: We included 142 patients, 44 children (64% males) and 98 adults (73% females). We found that 8 (18.18%) children and 35 (35.7%) adults had a positive skin prick test to Casuarina equisetifolia. None of the patients included in the study had a positive skin prick test to Pinus spp. CONCLUSIONS: Sensitization to Casuarina equisetifolia is as important as other pollens found in Mexico City. These results suggest that it should be included when skin prick tests are performed. Pinus spp pollen is considered an aeroallergen in European countries but we did not corroborate sensitization in our population.

ANTECEDENTES: los estudios de polinosis efectuados en la Ciudad de México han encontrado una cantidad importante de polen de Casuarina equisetifolia y Pinus spp, la frecuencia de sensibilización a estos pólenes se desconoce. Estos alergenos no se han relacionado con asma bronquial o rinitis alérgica en México, a pesar de que estudios efectuados en otros países han demostrado su relevancia como aeroalergenos. OBJETIVO: determinar la frecuencia de sensibilización al polen de Casuarina equisetifolia y Pinus spp. PACIENTES Y MÉTODO: estudio transversal, descriptivo, efectuado en el servicio de Alergia e Inmunología Clínica del Hospital General de México. Previo consentimiento informado, se incluyeron 142 pacientes de 3 a 55 años de edad con diagnóstico de rinitis alérgica, asma o ambas. Se les realizó historia clínica completa, estudios de laboratorio, gabinete y pruebas cutáneas por punción. RESULTADOS: de los 142 pacientes, se incluyeron 44 niños (64% de sexo masculino) y 98 adultos (73% de sexo femenino). Se encontró que 8 (18.1%) niños y 35 (35.7%) adultos tuvieron reacción positiva en la prueba cutánea para Casuarina equisetifolia. Ninguno de los pacientes incluidos en el estudio tuvo reacción positiva a la prueba cutánea para Pinus spp. La frecuencia de sensibilización a Casuarina equisetifolia fue ligeramente menor a la de otros pólenes frecuentemente encontrados en la Ciudad de México. CONCLUSIONES: la sensibilización al polen de Casuarina equisetifolia es tan importante como la de otros pólenes encontrados en la Ciudad de México. Con estos resultados se sugiere que este polen se incluya en la práctica de pruebas cutáneas. El polen de Pinus spp es un aeroalergeno en países europeos. Sin embargo, en nuestra población no corroboramos la sensibilización al mismo.