Objective To study the possible association between invasive fungal sinusitis (mucormycosis) and coronavirus disease. Methods A prospective observational study was conducted at a tertiary care centre over four months, involving all patients with mucormycosis of the paranasal sinuses suffering from or having a history of coronavirus disease infection. Results Twenty-three patients presented with mucormycosis, all had an association with coronavirus disease 2019. The ethmoids (100 per cent) were the most common sinuses affected. Intra-orbital extension was seen in 43.47 per cent of cases, while intracranial extension was only seen in 8.69 per cent. Diabetes mellitus was present in 21 of 23 cases, and was uncontrolled in 12 cases. All patients had a history of steroid use during their coronavirus treatment. Conclusion New manifestations of coronavirus disease 2019 are appearing over time. The association between coronavirus and mucormycosis of the paranasal sinuses must be given serious consideration. Uncontrolled diabetes and over-zealous use of steroids are two main factors aggravating the illness, and both of these must be properly checked.
The sample size for this study was small. However, based on the encouraging results of this proof-of-concept study, longer duration studies in larger population can be conducted to further confirm these findings. TRIAL REGISTRATION DETAILS: Clinical Trial Registry-India URL: http://ctri.nic.in, Registration Number: CTRI/2009/091/001036.
This phase II / III clinical trial was conducted to evaluate the immunogenicity and safety of the Tetravalent Influenza vaccine (Split virion) I.P. (TetIV) developed indigenously in the country for the first time by M/s Cadila Healthcare Limited, India containing two influenza A and two influenza B strains, one of each, Yamagata (B/Phuket) and Victoria (B/Brisbane) lineage and also compare it to that of an licensed seasonal Trivalent Influenza vaccine (TriIV) of Sanofi Pasteur India Private Limited, containing the two influenza A and only the Yamagata lineage (B/Phuket) strain. Three hundred and fifty subjects of either sex, aged more than 18 years of age, were randomized in a 1:1 ratio to receive either the TetIV or TriIV. Immunogenicity assessments (antibody against A/H1N1, A/H3N2, B/Phuket and B/Brisbane) were done by Haemagglutination Inhibition assay at baseline and 21 d after vaccination. Solicited (local and systemic) and unsolicited adverse events were recorded for up to 42 d following vaccination. The TetIV was found to fulfill the criteria set by the European and the US regulatory authorities and WHO guidance on the requirements of clinical data for licensure of seasonal inactivated influenza vaccines. The seroconversion rates with TetIV were 93.5% for A/H1N1, 90.0% for A/H3N2, 70.0% for B/Phuket and 82.9% for B/Brisbane strain. There was no significant difference in the seroconversion and seroprotection rates at day 21 for A/H1N1, A/H3N2 and B/Phuket in the two groups while the TetIV was superior to the TrivIV for the seroconversion and the seroprotection rate for the B/Brisbane strain (Victoria lineage). Both the vaccines were well tolerated by all the study participants; addition of the fourth strain in the TetIV did not compromise the safety as compared to TriIV. The most common systemic adverse event reported in both the groups was headache followed by fever.
Background/Aim: The recent pandemic of Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2) is yet another scourge from the coronaviridae family that causes illnesses ranging from common cold to more severe diseases such as Middle East respiratory syndrome (MERS-CoV) and severe acute respiratory syndrome (SARS-CoV). The numbers are still on the rise, despite a country wide lockdown and yet no definitive drugs and or/vaccines are available to manage the active COVID-19 cases. Methods: The present research design was a hospital based observational descriptive study conducted at S. M. S. Medical College and Attached hospitals, Jaipur, that analysed data of all the patients with COVID-19 related mortality, admitted between 1 April to 4 May 2020. Patients included in this study were RT-PCR confirmed cases of SARS-CoV-2 using nasopharyngeal and oropharyngeal swab samples. Results: The mean age of patients with COVID-19 related mortality was 53.41 ± 18.42 year with majority of patients belonging to age group of more than 60 years (41.18 %) followed closely by COVID-19 positive patients in age range of 45 to 60 years (33.33 %). The male to female ratio was 1.68: 1. Mean time lag between hospitalization and death reported was 6.18 days. Majority of the patients admitted (72.5 %) succumbed within 3 days of hospitalization. Eleven patients (21 %) were brought dead to the hospital who were tested COVID-19 positive after death. Most common comorbidity reported in patients with COVID-19 related mortality was hypertension (30 %) followed by diabetes mellitus (27.5 %). Conclusion: Hypertension and diabetes mellitus might be independent risk factors making an individual susceptible to COVID-19 related death. Elderly patients also have a greater risk of mortality. The non-availability of definitive management protocol and/or vaccine against COVID-19 makes public health preventive measures of social distancing, use of masks and frequent handwashing an important modality in the fight against COVID-19.
Background Limited supply, cost and potential for severe adverse effects observed with the blood derived rabies immunoglobulin products has led to search for alternative therapies. This issue has been addressed by developing an antirabies monoclonal antibody cocktail. Methods This is a phase 3, randomized, open-label, noninferiority trial conducted in patients with WHO category III exposure with suspected rabid animal. Eligible patients were assigned to either the test arm, TwinrabTM (docaravimab and miromavimab) or the reference arm, Human rabies immunoglobulin (HRIG; Imogam® Rabies-HT), in a ratio of 1:1. The primary endpoint was the comparison of responder rates between the two arms assessed as percentage of those with rabies virus neutralizing antibodies titers ≥ 0.5 IU/mL on day 14. Results A total of 308 patients were equally randomized into the two arms. In the per-protocol (PP) population, there were 90.21% responders in the TwinrabTM arm and, 94.37% in the HRIG arm. The Geometric Mean of RFFIT titres in the PP on day 14 were 4.38 and 4.85 IU/mL, for the TwinrabTM and HRIG arms, respectively. There were no deaths or serious adverse events reported. Conclusions This study confirmed that TwinrabTM is non-inferior to HRIG in terms of providing an unbroken window of protection up to day 84. This trial in healthy adults with WHO category III exposure from suspected rabid animal also establishes the safety of TwinrabTM in patients with one WHO approved vaccine regimen (Essen). Trials Registration CTRI/2017/07/009038
CONTEXT: The outbreak and spread of severe acute respiratory syndrome coronavirus 2 has led to a global exigency of colossal and monstrous proportions in terms of public health and economic crisis. Till date, no pharmaceutical agent is known to manage in terms of prevention and treatment of coronavirus disease 2019 (COVID-19), the disease caused by a novel virus. AIMS: The aim of the present work was to understand the underlying disease profile and dynamics that could provide relevant inputs and insight into pathophysiology and prevent further spread and evolve management strategies of COVID-19 patients from data-driven techniques. SETTINGS AND DESIGN: A retrospective observational descriptive study was conducted on 29 COVID-19 patients admitted at a premier medical institution of North India in the months of February and March 2020. METHODS: The patients were diagnosed with reverse transcription-polymerase chain reaction test. Demographic, clinical, and laboratory data were collected. RESULTS: The mean age of population was 38.8 years with male preponderance, of which two patients were residents of Italy, and others hailed from semi-arid and Western sandy arid regions of Rajasthan (urban population). The major presenting symptom complex of said COVID-19 sample population included fever (48%), cough (31%), and shortness of breath (17%). Most of the patients (83%) had no comorbidity. No clinical correlation (r) could be appreciated between the duration of test positivity and age of afflicted COVID-19 patients (r = −0.0976). CONCLUSIONS: The present evaluation of various facets of the ongoing global pandemic of COVID-19 is an attempt to portray early clinical and epidemiological parameters of the menace of COVID-19 patients admitted at SMS Medical College and Attached Hospitals, Jaipur.
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