Double-blind placebo-controlled randomized clinical trial to assess the efficacy of montelukast in mild to moderate respiratory symptoms of patients with long COVID: E-SPERANZA COVID Project study protocol

Background The coronavirus disease 2019 (COVID-19) pandemic continues to affect the globe. After 18 months of the SARS-CoV-2 emergence, clinicians have clearly defined a subgroup of patients with lasting, disabling symptoms. While big strides have been made in understanding the acute phase of SARS-CoV-2 infection, the pathophysiology of long COVID is still largely unknown, and evidence-based, effective treatments for this condition remain unavailable. Objectives To evaluate the efficacy of 10 mg oral montelukast every 24 h versus placebo in improving quality of life associated with mild to moderate respiratory symptoms in patients with long COVID as measured with the COPD Assessment Test (CAT) questionnaire. The secondary objectives will evaluate the effect of montelukast versus placebo on improving exercise capacity, COVID-19 symptoms (asthenia, headache, mental confusion or brain fog, ageusia, and anosmia), oxygen desaturation during exertion, functional status, and mortality. Methods and analysis Phase III, randomized, double-blind clinical trial. We will include 18- to 80-year-old patients with SARS-CoV-2 infection and mild to moderate respiratory symptoms lasting more than 4 weeks. Participants will be randomly allocated in a 1:1 ratio to the intervention (experimental treatment with 10 mg/day montelukast) or the control group (placebo group), during a 28-day treatment. Follow-up will finish 56 days after the start of treatment. The primary outcome will be health-related quality of life associated with respiratory symptoms according to the COPD Assessment Test 4 weeks after starting the treatment. The following are the secondary outcomes: (a) exercise capacity and oxygen saturation (1-min sit-to-stand test); (b) Post-COVID-19 Functional Status Scale; (c) other symptoms: asthenia, headache, mental confusion (brain fog), ageusia, and anosmia (Likert scale); (d) use of healthcare resources; (e) mortality; (f) sick leave duration in days; and (g) side effects of montelukast. Ethics and dissemination This study has been approved by the Clinical Research Ethics Committee of the IDIAPJGol (reference number 21/091-C). The trial results will be published in open access, peer-reviewed journals and explained in webinars to increase awareness and understanding about long COVID among primary health professionals. Trial registration ClinicalTrials.govNCT04695704. Registered on January 5, 2021. EudraCT number 2021-000605-24. Prospectively registered.

Headache, anosmia, ageusia and other neurological symptoms in COVID-19: a cross-sectional study

Background Neurological symptoms are frequent among patients with COVID-19. Little is known regarding the repercussions of neurological symptoms for patients and how these symptoms are related to one another. Objectives To determine whether there is an association between the neurological symptoms in patients with COVID-19, and to characterize the headache. Method This was a cross-sectional study. All hospital inpatients and health workers at the Hospital Universitario Oswaldo Cruz with a PCR-confirmed COVID-19 infection between March and June 2020 were considered for the study and were interviewed by telephone at least 2-months after the acute phase of the disease. These patients were identified by the hospital epidemiological surveillance department. A semi-structured questionnaire was used containing sociodemographic and clinical data and the ID-Migraine. Results A total of 288 patients was interviewed; 53.1% were male; with a median age of 49.9 (41.5–60.5) years; 91.7% presented some neurological symptom; 22.2% reported some neurological symptom as the symptom that troubled them most during COVID-19. Neurological symptoms were: ageusia (69.8%), headache (69.1%), anosmia (67%), myalgia (44.4%), drowsiness (37.2%), agitation (20.8%); mental confusion (14.9%), syncope (4.9%) and epileptic seizures (2.8%). Females, those who presented with fever, sore throat, anosmia/ageusia and myalgia also presented significantly more with headache (logistic regression). The most frequent headache phenotype was a non-migraine phenotype, was of severe intensity and differed from previous headaches. This persisted for more than 30 days in 18% and for more than 90 days in 10% of patients. Thirteen percent of those with anosmia and 11% with ageusia continued with these complaints after more than 90 days of the acute phase of the disease. Aged over 50 years, agitation and epileptic seizures were significantly associated with mental confusion (logistic regression). Conclusion Headache is frequent in COVID-19, is associated with other symptoms such as fever, sore throat, anosmia, ageusia, and myalgia, and may persist beyond the acute phase of the disease.

Double-blind Placebo-controlled Randomized Clinical Trial to Assess the Efficacy of Montelukast in Mild to Moderate Respiratory Symptoms of Patients With Long COVID E-SPERANZA COVID PROJECT Study Protocol

BackgroundThe coronavirus disease-2019 (COVID-19) pandemic continues to affect the globe. After eighteen months of the SARS-CoV-2 emergence, clinicians have clearly defined a subgroup of patients with lasting, disabling symptoms. While big strides have been made in understanding the acute phase of SARS-CoV-2 infection, the pathophysiology of long COVID is still largely unknown and evidence-based, effective treatments for this condition remain unavailable. ObjectivesTo evaluate the efficacy of 10 mg oral montelukast every 24 hours versus placebo in improving quality of life associated with mild to moderate respiratory symptoms in patients with long COVID as measured with the COPD Assessment Test (CAT) questionnaire. The secondary objectives will evaluate the effect of montelukast versus placebo on improving: exercise capacity; COVID-19 symptoms (asthenia, headache, mental confusion or brain fog, ageusia, and anosmia); oxygen desaturation during exertion; functional status; and mortality. Methods and analysisPhase III, randomized, double-blind clinical trial. We will include 18 to 80 year-old patients with SARS-CoV-2 infection and mild to moderate respiratory symptoms lasting more than 4 weeks. Participants will be randomly allocated in a 1:1 ratio to the intervention (experimental treatment with 10 mg/day montelukast) or the control group (placebo group), during a 28-day treatment. Follow up will finish 56 days after start of treatment. The primary outcome will be health-related quality of life associated with respiratory symptoms according to the COPD Assessment Test 4 weeks after starting treatment. Secondary outcomes a) Exercise capacity and oxygen saturation (1Min Sit-to-Stand test); b) Post-COVID-19 Functional Status scale; c) Other symptoms: asthenia, headache, mental confusion (brain fog), ageusia and anosmia (Likert scale); d) Use of healthcare resources; e) Mortality; f) Sick leave duration in days g) Side effects of montelukast. Ethics and disseminationThis study has been approved by the Clinical Research Ethics Committee of the IDIAPJGol (reference number 21/091-C). The trial results will be published in open access, peer-reviewed journals and explained in webinars to increase awareness and understanding about long COVID among primary health professionals. Trial registrationClinicalTrials.gov Identifier: NCT04695704 first posted on January, 5, 2021. EudraCT number 2021-000605-24). Prospectively registered.

Probable first report of a motor deafferentation syndrome in the Paraguayan War

ABSTRACT The Paraguayan War ended 150 years ago. Back then, there were outbreaks of combatants’ limb weakness and tingling related to "palustrian cachexia", not clearly funded at the time on nutritional deficiency, the use of native flora to feed troops, and alcoholism. We report a case of a soldier with ascending paralysis, mental confusion and finally tetraplegia with preserved oculomotricity. This would probably be a case of locked-in syndrome (LIS) due to Gayet-Wernicke's encephalopathy consequent to thiamine deficiency. The role of thiamine in the peripheral or central nervous system expression was shown decades later to be related to poor diet, or use of foods containing thiaminase or thiamine antagonists, worsened by the fact that the bodily stores of thiamine are restricted, and deficits may grow fast.

Acute Disseminated Encephalomyelitis after endophthalmitis in immunosuppresed patient

Context: Acute Disseminated Encephalomyelitis (ADEM) usually happens after an infectious event, vaccination reaction and with history of immunosuppression. Clinical features can be varied: headache, fever, seizure, blurred vision, ataxia, motor deficits and mental confusion. Case report: A 35-yearsold woman, in a social risk situation, complained about pain and blurred vision, history of cocaine abuse, victim of sexual and physical abuse and recent Measles vaccination. She had corneal ulcer with bilateral endophthalmitis and optic nerve infection. Despite intravitreal injections of Vancomycin + Ceftazidime, patient had to eviscerate the left eye. After surgery, patient evolved with mental confusion and paraparesis, CSF cell 69, lymphomonocyte, proteins 257, MRI showed central bulbar hyperintensity, lesions in the dentate nucleus and periaqueductal of gray substance in T2 / FLAIR, thoracic and lumbar spine with demyelinating pattern, extensive longitudinal myelitis. Patient obtained clinical improvement after treatment with Methylprednisolone 1gr for 5 days. It is important to discard other hypothesis: transverse myelitis, neuromyelitis optica, multiple sclerosis and systemic lupus erythematosus. The diagnosis is clinical and radiological with multifocal and confluent areas of hypersignal on MRI, CSF analysis reveals high protein and lymphocytic pleocytosis. Treatment with Methylprednisolone is the first choice and then Plasmapheresis. Conclusion: there are several risk factors for the development of ADEM correlated with a rapid and aggressive evolution in this patient.

A Clinical Study to evaluate the effect of Dushivishari Ajay Ghrita in Dushivisha Janya Lakshana

Dushivisha is a unique concept of Ayurveda. Bruhatrayi explains spectrum of Dushivisha concept in many ways as a important concept related in Vishatatra statement. Dushivisha is any low potency toxic substance which vitiates the Dhatus when favorable condition occurs. It produces different symptoms in different people according to their age, habits and place of residence. In the Ayurveda context the poison has been divided into sub types and there is no separate classification of Dushivisha, But Ayurveda defines it as Sthavara, Jangama or Kritimavisha after its treatment, when it becomes less potent its effects are doesn’t nullifies radically because of which it resides in the body, that particular less potent part of above said poison is called Dushivisha. Dushivisha produces sense of intoxication after meals, indigestion, anorexia, eruption of circular patches on the skin, urticaria, mental confusion, Dhatukashya, oedema on the face and extremities, ascites, vomiting, diarrhoea, discolouration, fainting, intermittent high grade fever and unquenched able thirst. Some poisons produce insanity, abdominal distension, Shukra Kshaya, muffled voice while other causes Kustha and respective disorders of various type. Acharya Shusruta mention Ajay Gritha in the treatment of Dushivisha. So this article aim to collect the data to evaluate the effect of Ajay Ghrita in Dushivishajanya Lakshana.

Efeito do resultado do jogo sobre os estados de humor de uma equipe de voleibol

Objetivo: verificar o efeito do resultado do jogo sobre os estados de humor de uma equipe de voleibol feminino. Métodos: doze atletas amadoras responderam ao POMS (Perfil dos Estados de Humor) 30 minutos antes e 30 minutos após sete partidas de um campeonato intermunicipal de voleibol. Foram analisadas as variáveis: tensão, depressão, raiva, vigor, fadiga e confusão mental. Resultados: em relação ao perfil de humor da equipe, verificou-se que nas derrotas houve aumento significativo de tensão, raiva e confusão mental e queda no vigor quando comparado a situação de vitória. Conclusão: o estado de humor de uma equipe de voleibol feminino é influenciado pelo resultado do jogo.ABSTRACT. Effect of outcome of the game on the moods of a volleyball team. Objective: verify the effect of the game outcome on female volleyball team’s mood states. Methods: twelve amateur athletes were submitted to POMS (Profile of Mood States), 30 minutes before and 30 minutes after seven matches of an intercity championship. Dependent variables were tension, depression, anger, vigor, fatigue and confusion. Results: regarding the team’s humor profile, it was verified that in the defeats there was a significant increase of tension, anger and mental confusion and decrease in vigor when compared to the situation of victory. Conclusion: the outcome of the game was found to influence female volleyball team’s mood states.