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1.
J Family Med Prim Care ; 10(12): 4341-4344, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1689982

ABSTRACT

Azithromycin is an antibiotic commonly used for treating respiratory, gastrointestinal infections besides enteric fever, otitis media etc. It's convenient short duration oral dosing regimens and good tolerability make it a popular drug in routine outpatient settings in primary to tertiary care. Pre-clinical studies have shown immunomodulatory and in vitro activity of azithromycin against SARS CoV-2, which has led to its widespread usage in COVID-19. However, subsequent reviews of observational studies assessing its efficacy in different grades of COVID-19, as well as data from well conducted randomised clinical trials (RCTs) in mild - moderate COVID-19 have shown no or very low quality evidence of benefit of the drug on various clinical outcome parameters. Still, the drug continues to be used indiscriminately in many parts of India for treatment of home isolated patients of mild COVID-19. Such injudicious use in the community should be stopped, otherwise there will be serious adverse consequences of development of resistance to this very useful antibiotic during this pandemic.

3.
Indian J Med Res ; 153(1 & 2): 219-226, 2021.
Article in English | MEDLINE | ID: covidwho-1170493

ABSTRACT

BACKGROUND & OBJECTIVES: Hydroxychloroquine (HCQ), reported to inhibit severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) replication in in vitro studies, has been recommended for prophylaxis of COVID-19 in healthcare workers (HCWs). The objective of this study was to assess short-term adverse events (AEs) of HCQ in HCWs. METHODS: This cross-sectional study among consenting HCWs taking prophylaxis and working in hospitals with COVID-19 patients used online forms to collect details of HCWs, comorbidities, prophylactic drugs used and AEs after the first dose of HCQ. Verification of dose and AEs was done by personal contact. Multivariate logistic regression analysis was done to determine the effect of age, gender and dose of HCQ on AE. RESULTS: Of the 1303 HCWs included, 98.4 per cent (n=1282) took HCQ and 66 per cent (n=861) took 800 mg as first day's dose. Among the 19.9 per cent (n=259) reporting AEs, 1.5 per cent (n=20) took treatment for AE, none were hospitalized and three discontinued HCQ. Gastrointestinal AEs were the most common (172, 13.2%), with less in older [odds ratio (OR) 0.56, 95% confidence interval (CI) 0.35-0.89], with more in females (OR 2.46, 95% CI 1.78-3.38) and in those taking a total dose of 800 mg on day one compared to a lower dose. Hypoglycaemia (1.1%, n=14), cardiovascular events (0.7%, n=9) and other AEs were minimal. INTERPRETATION & CONCLUSIONS: HCQ prophylaxis first dose was well tolerated among HCWs as evidenced by a low discontinuation. For adverse effects, a small number required treatment, and none required hospitalization. The study had limitations of convenience sampling and lack of laboratory and electrocardiography confirmation of AEs.


Subject(s)
COVID-19/drug therapy , COVID-19/prevention & control , Health Personnel , Hydroxychloroquine , Cross-Sectional Studies , Female , Humans , Hydroxychloroquine/adverse effects , Hydroxychloroquine/therapeutic use , Male , Pre-Exposure Prophylaxis
4.
BioDrugs ; 34(6): 705-711, 2020 Dec.
Article in English | MEDLINE | ID: covidwho-848562

ABSTRACT

Itolizumab is a first-in-class anti-CD6 monoclonal antibody that was initially developed for various cancers and was later developed and approved in India for treatment of moderate to severe chronic plaque psoriasis in 2013. This drug is now being re-purposed for COVID-19. The potential utility of itolizumab in COVID-19, based on its unique mechanism of action in ameliorating cytokine release syndrome (CRS), was proposed first in Cuba with approval of a single-arm clinical trial and expanded access use. Subsequently, a phase II, open-label, randomized, placebo-controlled trial has been conducted in 30 COVID-19 patients in India after receiving regulatory permission. Based on the results, the Indian drug regulatory agency recently approved itolizumab in July 2020 for 'restricted emergency use' for the treatment of CRS in moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19. This has drawn sharp criticism within the scientific community, with the approval being granted on the basis of a relatively small phase II trial, without conduct of a conventional phase III trial, and lacking availability of the claimed supportive real-world evidence in the public domain to date. In a global scenario where finding a successful treatment for COVID-19 is of utmost priority, a biologic agent has been re-purposed and approved with a successfully completed RCT, in a country where cases and mortality due to COVID-19 are growing exponentially. However, instead of welcoming the approval with open arms, many doubts are being raised. This is an issue that needs to be considered and dealt with sensitively, as well as scientifically.


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , Coronavirus Infections/drug therapy , Drug Approval , Pneumonia, Viral/drug therapy , Antibodies, Monoclonal, Humanized/pharmacology , COVID-19 , Drug Repositioning , Humans , India , Pandemics
5.
Diabetes Res Clin Pract ; 166: 108316, 2020 Aug.
Article in English | MEDLINE | ID: covidwho-640886

ABSTRACT

Providing scheduled consultations to persons with diabetes during the COVID-19 induced lockdowns posed a major challenge. With the clinicians occupied in COVID management, a strategy of using telemedicine and engaging a team of para-clinical doctors was devised. Telephonic follow up consults were given and diabetes care was efficiently delivered.


Subject(s)
Betacoronavirus/isolation & purification , Coronavirus Infections/complications , Diabetes Mellitus/drug therapy , Insulin/therapeutic use , Pneumonia, Viral/complications , Referral and Consultation/statistics & numerical data , Telemedicine/methods , Tertiary Care Centers/statistics & numerical data , Blood Glucose/analysis , COVID-19 , Coronavirus Infections/epidemiology , Coronavirus Infections/virology , Diabetes Mellitus/physiopathology , Diabetes Mellitus/virology , Female , Humans , Hypoglycemic Agents/therapeutic use , India/epidemiology , Male , Middle Aged , Pandemics , Pneumonia, Viral/epidemiology , Pneumonia, Viral/virology , SARS-CoV-2
6.
Pharmaceut Med ; 34(4): 223-231, 2020 08.
Article in English | MEDLINE | ID: covidwho-597467

ABSTRACT

At present, there are no proven agents for treatment of coronavirus disease (COVID-19). The available evidence has not allowed guidelines to clearly recommend any drugs outside the context of clinical trials. The novel coronavirus SARS-CoV-2 that causes COVID-19 invokes a hyperinflammatory state driven by multiple cells and mediators like interleukin (IL)-1, IL-6, IL-12, and IL-18, tumor necrosis factor alpha (TNFα), etc. Considering the proven role of cytokine dysregulation in causing this hyperinflammation in the lungs with IL-6 being a key driver, particularly in seriously ill COVID-19 patients, it is crucial to further explore selective cytokine blockade with drugs like the IL-6 inhibitors tocilizumab, sarilumab, and siltuximab. These targeted monoclonal antibodies can dampen the downstream IL-6 signaling pathways, which can lead to decreased cell proliferation, differentiation, oxidative stress, exudation, and improve clinical outcomes in patients with evident features of cytokine-driven inflammation like persistent fever, dyspnea and elevated markers. Preliminary evidence has come for tocilizumab from some small studies, and interim analysis of a randomized controlled trial; the latter also being available for sarilumab. International guidelines do include IL-6 inhibitors as one of the options available for severe or critically ill patients. There has been increased interest in evaluating these drugs with a series of clinical trials being registered and conducted in different countries. The level of investigation though perhaps needs to be further intensified as there is a need to focus on therapeutic options that can prove to be 'life-saving' as the number of COVID-19 fatalities worldwide keeps increasing alarmingly. IL-6 inhibitors could be one such treatment option, with generation of more evidence and completion of a larger number of systematic studies.


Subject(s)
Coronavirus Infections/drug therapy , Interleukin-6/antagonists & inhibitors , Pneumonia, Viral/drug therapy , Animals , Antibodies, Monoclonal/administration & dosage , Antibodies, Monoclonal/immunology , Betacoronavirus/immunology , Betacoronavirus/isolation & purification , COVID-19 , Clinical Trials as Topic , Coronavirus Infections/immunology , Coronavirus Infections/physiopathology , Cytokines/immunology , Humans , Interleukin-6/immunology , Pandemics , Pneumonia, Viral/immunology , Pneumonia, Viral/physiopathology , SARS-CoV-2
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