Disinformation about COVID-19 Preventions and Treatments: Analysis of USFDA Warning Letters.

COVID-19 poses a challenge beyond the virus itself, in that lockdown has been associated increased use of the internet and social media. Disinformation about prevention and treatment strategies for COVID-19 can have lethal consequences. The United States Food and Drug Administration (USFDA) is currently monitoring the compliance of manufacturing firms as well as medicinal product advertisers to the Federal Food, Drug, and Cosmetic Act, 21 USC § 321(h) regulations. In the event of noncompliance in the form of advertising products without prior USFDA approval for specific indications, doses, or route of administration, warning letters (WLs) are issued. WLs are intended to address the concerns identified by USFDA and encourage the recipient to take corrective steps to avoid similar instances in the future. We analyzed 182 WLs that were issued for noncompliance with drugs/devices related to either treatment, prevention, or testing of COVID-19 infections. The medicinal product website was identified as the major source of disinformation, followed by disseminated information on Facebook, Twitter, and Instagram. Nearly four-fifths were related to drugs, followed by devices and biologicals. Several biologicals, as well as allopathic, herbal, and non-herbal drugs were identified in the WLs. We observed that noncompliance with the USFDA regulations in terms of advertising a variety of products for prevention and treatment of COVID-19 infection was widely prevalent. More efforts are required by the respective national drug regulatory authorities to initiate or continue their monitoring of disinformation that may have lethal consequences.

A systematic review of arterial dissections in COVID-19 patients.

COVID-19 is often seen presenting with a myriad of signs and symptoms of multiorgan dysfunction including arterial dissection. Various theories have been proposed such as endothelial dysfunction triggered by hyper-inflammatory response that results in rupture of atherosclerotic plaque and subsequent dissection. However, the exact incidence is unknown and only case reports and case series have been published till date. Here we carried out a systematic analysis of published case reports/series related to dissection of the aorta, coronary, cerebral, vertebral, cervical, renal, and splanchnic arteries.

Intrapleural Tenecteplase for Complicated Parapneumonic Pleural Effusion.

Intrapleural thrombolytics have shown promising results in complicated parapneumonic pleural effusions reducing the need for surgical interventions. Until now, studies have evaluated primarily streptokinase, urokinase, and recently, alteplase. In this case series, we share our experience with tenecteplase-a tissue-specific plasminogen activator in 15 patients. We observed that tenecteplase is effective in 14/15 (93.3%) of our patients, and none of them had any bleeding episodes.

Utility of inflammatory biomarkers in patients with COVID-19 infections: Bahrain experience.

Aim: COVID-19 pandemic continues and dearth of information remains considering the utility of various inflammatory biomarkers. We carried out the present study to delineate the roles of these biomarkers in various strata of patients with coronavirus infection. Materials & methods: A retrospective study was carried out after obtaining approval from the relevant Ethics Committee. Patients established with COVID-19 infection as shown by positive real-time quantitative PCR test were included. Details on their demographics, diagnosis, whether they received tocilizumab, and the values of the following biomarkers were obtained: IL-6, C-reactive protein (CRP), serum ferritin, D-dimer, procalcitonin, fibrinogen, lactate dehydrogenase and creatinine kinase. Receiver operating characteristic curves were plotted and correlation of biomarkers with IL-6 were estimated. Results: One-hundred and three patients were recruited. We observed that serum ferritin followed by D-dimer had better predictive accuracy in identifying patients with pneumonia compared with asymptomatic; and CRP in addition to the earlier markers had better accuracy for predicting severe illness compared with mild-moderate. Serum IL-6 levels were significantly higher in patients with severe illness admitted in intensive care unit. Significantly, higher levels of IL-6 and serum ferritin were observed in patients receiving tocilizumab. A trend of increased IL-6 levels was observed immediately following the initiation of tocilizumab therapy followed by a drop thereafter. Conclusion: We observed serum ferritin, D-dimer and CRP to accurately predict patients developing severe COVID-19 infections as well as those at risk of developing COVID pneumonia. A trend in IL-6 levels was observed in patients on tocilizumab therapy.

Dexamethasone in severe COVID-19 infection: A case series.

Evidence supporting the use of dexamethasone in severe COVID-19 patients is emerging. In this case series, we share our experience in using dexamethasone in five COVID-19 infected patients with acute respiratory distress syndrome.

Efficacy and safety of tocilizumab in critically ill adults with COVID-19 infection in Bahrain: A report of 5 cases.

Tocilizumab has been recognized as one of the few existing biologic useful for combating COVID-19 infections especially in critically ill patient. We had experience in treating five critically ill patients with severe lung injury who were COVID-19 positive with tocilizumab. In the present case series, we have attempted to summarize their clinical profile, changes in laboratory biomarkers and outcomes.