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1.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-311088

ABSTRACT

Background: Statins and aspirin have been advocated for treatment of Covid-19 owing to anti-inflammatory and anti-thrombotic properties and have shown favorable results in observational studies. There is a need for randomized controlled trial.Methods: We conducted a single-center, four-arm parallel design, open-label randomized controlled trial on RT-PCR positive Covid-19 patients, ≥ 40 years and < 75 years of age, requiring hospitalization [World Health Organization (WHO) Ordinal Scale for Clinical Improvement 3 to 5]. Patients were randomly assigned to either atorvastatin 40 mg (group A), aspirin 75 mg (group B), or both (group C) in addition to standard of care for 10 days or until discharge whichever was earlier or only standard of care (group D). The primary outcome variable was clinical deterioration to WHO Ordinal Scale for Clinical Improvement ≥ 6. The secondary outcome was change in serum inflammatory markers (C-reactive protein and Interleukin-6), and Troponin I.Findings: A total of 900 patients underwent randomization (with Groups A, B, C and D assigned 224, 225, 225 and 226 patients respectively). The primary outcome occurred in 25 (2.8%) patients: 7 (3.2%) in Group A, 3 (1.4%) in Group B, 8 (3.6%) in Group C and 7 (3.2%) in Group D. There was no difference in primary outcome across the study groups (P=0.463). Comparison of all patients who received atorvastatin or aspirin with the control group (Group D) also did not show any benefit [Atorvastatin: HR 1.0 (95% CI 0.41 - 2.46);Aspirin: HR 0.7 (95% CI 0.27 - 1.81)]. The secondary outcomes revealed lower serum IL-6 among patients in Groups B and C. There was no excess of adverse events.Interpretation: Among patients admitted with mild to moderate Covid-19 infection, additional treatment with aspirin, atorvastatin or a combination of the two does not prevent clinical deterioration.Trial Registry Number: CTRI/2020/07/026791 (http://ctri.nic.in;registered on 25th July 2020)Funding: None to declare. Declaration of Interest: None to declareEthical Approval: The trial was approved by the institutional ethical committee.

2.
Curr Probl Diagn Radiol ; 50(6): 842-855, 2021.
Article in English | MEDLINE | ID: covidwho-1294548

ABSTRACT

Coronavirus Disease 2019 (COVID-19) disease has rapidly spread around the world after initial identification in Wuhan, China, in December 2019. Most common presentation is mild or asymptomatic disease, followed by pneumonia, and rarely- multiorgan failure and Acute Respiratory Distress Syndrome (ARDS). Knowledge about the pathophysiology, imaging and treatment of this novel virus is rapidly evolving due to ongoing worldwide research. Most common imaging modalities utilized during this pandemic are chest radiography and HRCT with findings of bilateral peripheral, mid and lower zone GGO and/or consolidation, vascular enlargement and crazy paving. HRCT is also useful for prognostication and follow-up of severely ill COVID-19 patients. Portable radiography allows follow-up of ICU patients & obviates the need of shifting critically ill patients and disinfection of CT room. As the pandemic has progressed, numerous neurologic manifestations have been described in COVID-19 including stroke, white matter hyperintensities and demyelination on MRI. Varying abdominal presentations have been described, which on imaging either show evidence of COVID-19 pneumonia in lung bases or show abdominal findings including bowel thickening and vascular thrombosis. Numerous thrombo-embolic and cardiovascular complications have also been described in COVID-19 including arterial and venous thrombosis, pulmonary embolism and myocarditis. It is imperative for radiologists to be aware of all the varied faces of this disease on imaging, as they may well be the first physician to suspect the disease. This article aims to review the multimodality imaging manifestations of COVID-19 disease in various organ systems from head to toe.


Subject(s)
COVID-19 , Humans , Radiologists , SARS-CoV-2 , Toes , Tomography, X-Ray Computed
4.
J Thorac Imaging ; 36(2): 73-83, 2021 Mar 01.
Article in English | MEDLINE | ID: covidwho-972686

ABSTRACT

OBJECTIVE: Cardiac magnetic resonance imaging (CMR) with its new quantitative mapping techniques has proved to be an essential diagnostic tool for detecting myocardial injury associated with coronavirus disease 2019 (COVID-19) infection. This systematic review sought to assess the important imaging features on CMR in patients diagnosed with COVID-19. MATERIALS AND METHODS: We performed a systematic literature review within the PubMed, Embase, Google Scholar, and WHO databases for articles describing the CMR findings in COVID-19 patients. RESULTS: A total of 34 studies comprising 199 patients were included in the final qualitative synthesis. Of the CMRs 21% were normal. Myocarditis (40.2%) was the most prevalent diagnosis. T1 (109/150; 73%) and T2 (91/144; 63%) mapping abnormalities, edema on T2/STIR (46/90; 51%), and late gadolinium enhancement (LGE) (85/199; 43%) were the most common imaging findings. Perfusion deficits (18/21; 85%) and extracellular volume mapping abnormalities (21/40; 52%), pericardial effusion (43/175; 24%), and pericardial LGE (22/100; 22%) were also seen. LGE was most commonly seen in the subepicardial location (81%) and in the basal-mid part of the left ventricle in inferior segments. In most of the patients, ventricular functions were normal. Kawasaki-like involvement with myocardial edema without necrosis/LGE (4/6; 67%) was seen in children. CONCLUSION: CMR is useful in assessing the prevalence, mechanism, and extent of myocardial injury in COVID-19 patients. Myocarditis is the most common imaging diagnosis, with the common imaging findings being mapping abnormalities and myocardial edema on T2, followed by LGE. As cardiovascular involvement is associated with poor prognosis, its detection warrants prompt attention and appropriate treatment.


Subject(s)
COVID-19/complications , COVID-19/diagnostic imaging , Heart Diseases/complications , Heart Diseases/diagnostic imaging , Magnetic Resonance Imaging/methods , Heart/diagnostic imaging , Humans , SARS-CoV-2
5.
Trials ; 21(1): 902, 2020 Oct 30.
Article in English | MEDLINE | ID: covidwho-895026

ABSTRACT

OBJECTIVES: To assess the impact of adding statin (atorvastatin) and/or aspirin on clinical deterioration in patients infected with SARS-CoV-2 who require hospitalisation. The safety of these drugs in COVID-19 patients will also be evaluated. TRIAL DESIGN: This is a single-centre, prospective, four-arm parallel design, open-label, randomized control trial. PARTICIPANTS: The study will be conducted at National Cancer Institute (NCI), Jhajjar, Haryana, which is a part of All India Institute of Medical Sciences (AIIMS), New Delhi, and has been converted into a dedicated COVID-19 management centre since the outbreak of the pandemic. All RT-PCR confirmed cases of SARS-CoV-2 infection with age ≥ 40 years and < 75 years requiring hospital admission (patients with WHO clinical improvement ordinal score 3 to 5) will be included in the trial. Written informed consent will be taken for all recruited patients. Patients with a critical illness (WHO clinical improvement ordinal score > 5), documented significant liver disease/dysfunction (aspartate transaminase [AST] / alanine aminotransferase [ALT] > 240), myopathy and rhabdomyolysis (creatine phosphokinase [CPK] > 5x normal), allergy or intolerance to statins or aspirin, prior statin or aspirin use within 30 days, history of active gastrointestinal bleeding in past three months, coagulopathy, thrombocytopenia (platelet count < 100000/ dl), pregnancy, active breastfeeding, or inability to take oral or nasogastric medications will be excluded. Patients refusing to give written consent and taking drugs that are known to have a significant drug interaction with statin or aspirin [including cyclosporine, HIV protease inhibitors, hepatitis C protease inhibitor, telaprevir, fibric acid derivatives (gemfibrozil), niacin, azole antifungals (itraconazole, ketoconazole), clarithromycin and colchicine] will also be excluded from the trial. INTERVENTION AND COMPARATOR: In this study, the benefit and safety of atorvastatin (statin) and/or aspirin as adjuvant therapy will be compared with the control group receiving usual care for management of COVID-19. Atorvastatin will be prescribed as 40 mg oral tablets once daily for ten days or until discharge, whichever is earlier. The dose of aspirin will be 75 mg once daily for ten days or until discharge, whichever is earlier. All other therapies will be administered according to the institute's COVID-19 treatment protocol and the treating physician's clinical judgment. MAIN OUTCOMES: All study participants will be prospectively followed up for ten days or until hospital discharge, whichever is longer for outcomes. The primary outcome will be clinical deterioration characterized by progression to WHO clinical improvement ordinal score ≥ 6 (i.e., endotracheal intubation, non-invasive mechanical ventilation, pressor agents, renal replacement therapy, ECMO requirement, and mortality). The secondary outcomes will be change in serum inflammatory markers (C-reactive protein and Interleukin-6), Troponin I, and creatine phosphokinase (CPK) from time zero to 5th day of study enrolment or 7th day after symptom onset, whichever is later. Other clinical outcomes that will be assessed include progression to Acute Respiratory Distress Syndrome (ARDS), shock, ICU admission, length of ICU admission, length of hospital admission, and in-hospital mortality. Adverse drug effects like myalgia, myopathy, rhabdomyolysis, hepatotoxicity, and bleeding will also be examined in the trial to assess the safety of the interventions. RANDOMISATION: The study will use a four-arm parallel-group design. A computer-generated permuted block randomization with mixed block size will be used to randomize the participants in a 1:1:1:1 ratio to group A (atorvastatin with conventional therapy), group B (aspirin with conventional therapy), group C (aspirin + atorvastatin with conventional therapy), and group D (control; only conventional therapy). BLINDING (MASKING): The study will be an open-label trial. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): As there is no existing study that has evaluated the role of aspirin and atorvastatin in COVID-19 patients, formal sample size calculation has not been done. Patients satisfying the inclusion and exclusion criteria will be recruited during six months of study period. Once the first 200 patients are included in each arm (i.e., total 800 patients), the final sample size calculation will be done on the basis of the interim analysis of the collected data. TRIAL STATUS: The institutional ethical committee has approved the study protocol (Protocol version 3.0 [June 2020]). Participant recruitment starting date: 28th July 2020 Participant recruitment ending date: 27th January 2021 Trial duration: 6 months TRIAL REGISTRATION: The trial has been prospectively registered in Clinical Trial Registry - India (ICMR- NIMS): Reference no. CTRI/2020/07/026791 (registered on 25 July 2020)]. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Subject(s)
Aspirin/therapeutic use , Atorvastatin/therapeutic use , Betacoronavirus/pathogenicity , Coronavirus Infections/drug therapy , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Platelet Aggregation Inhibitors/therapeutic use , Pneumonia, Viral/drug therapy , Adult , Aged , Aspirin/adverse effects , Atorvastatin/adverse effects , COVID-19 , Coronavirus Infections/diagnosis , Coronavirus Infections/virology , Female , Host-Pathogen Interactions , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects , India , Male , Middle Aged , Pandemics , Platelet Aggregation Inhibitors/adverse effects , Pneumonia, Viral/diagnosis , Pneumonia, Viral/virology , Prospective Studies , Randomized Controlled Trials as Topic , SARS-CoV-2 , Time Factors , Treatment Outcome
6.
Glob Heart ; 15(1): 44, 2020 07 01.
Article in English | MEDLINE | ID: covidwho-761019

ABSTRACT

In this paper, we provide recommendations on the management of cardiovascular disease (CVD) among patients with confirmed or suspected coronavirus disease (COVID-19) to facilitate the decision making of healthcare professionals in low resource settings. The emergence of novel coronavirus disease, also known as Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2), has presented an unprecedented global challenge for the healthcare community. The ability of SARS-CoV-2 to get transmitted during the asymptomatic phase and its high infectivity have led to the rapid transmission of COVID-19 beyond geographic regions, leading to a pandemic. There is concern that COVID-19 is cardiotropic, and it interacts with the cardiovascular system on multiple levels. Individuals with established CVD are more susceptible to severe COVID-19. Through a consensus approach involving an international group this WHF statement summarizes the links between cardiovascular disease and COVID-19 and present some practical recommendations for the management of hypertension and diabetes, acute coronary syndrome, heart failure, rheumatic heart disease, Chagas disease, and myocardial injury for patients with COVID-19 in low-resource settings. This document is not a clinical guideline and it is not intended to replace national clinical guidelines or recommendations. Given the rapidly growing burden posed by COVID-19 illness and the associated severe prognostic implication of CVD involvement, further research is required to understand the potential mechanisms linking COVID-19 and CVD, clinical presentation, and outcomes of various cardiovascular manifestations in COVID-19 patients.


Subject(s)
Cardiovascular Diseases/complications , Cardiovascular Diseases/therapy , Coronavirus Infections/complications , Pneumonia, Viral/complications , COVID-19 , Clinical Decision-Making , Decision Trees , Health Resources , Humans , Pandemics , Practice Guidelines as Topic
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