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1.
World Neurosurg ; 157: e357-e363, 2022 01.
Article in English | MEDLINE | ID: covidwho-1757929

ABSTRACT

BACKGROUND: Prior studies demonstrated reduced risk for venous thromboembolism (VTE) in neurosurgical patients secondary to prophylaxis with both heparin and low-molecular-weight heparin. The ability to monitor low-molecular-weight heparin by obtaining anti-factor Xa (anti-Xa) serum levels provides an opportunity to evaluate safety and efficacy. The aim of this study was to describe characteristics of patients who have anti-Xa levels outside of the goal range (0.2-0.4/0.5 IU/mL) and investigate incidence of major bleeding and VTE. METHODS: A single-center, retrospective, observational study was conducted on neurosurgical patients receiving enoxaparin for VTE prophylaxis between August 2019 and December 2020. Significance testing was conducted via Fisher exact test and independent samples t test. RESULTS: The study included 85 patients. Patients were less likely to have an anti-Xa level in the goal range if they were male, had a higher weight, or were morbidly obese. Three neuroendovascular patients (3.5%) experienced a major bleed. Serum anti-Xa levels were significantly higher in patients who experienced major bleeds compared with patients who did not (0.45 ± 0.16 IU/mL vs. 0.28 ± 0.09 IU/mL, P = 0.003). Patients with a supraprophylactic anti-Xa level (>0.5 IU/mL) were more likely to experience a major bleed (P = 0.005). One VTE event occurred: the patient experienced a pulmonary embolism with anti-Xa level at goal. CONCLUSIONS: Anti-Xa-guided enoxaparin dosing for VTE prophylaxis in neurosurgical patients may help prevent major bleeding. These data suggest that a higher anti-Xa level may predispose patients to major bleeding. Further evaluation is needed to identify the goal anti-Xa level for VTE prophylaxis in this population.


Subject(s)
Enoxaparin/blood , Factor Xa Inhibitors/blood , Hemorrhage/blood , Neurosurgical Procedures/trends , Pre-Exposure Prophylaxis/trends , Adult , Aged , Anticoagulants/administration & dosage , Anticoagulants/adverse effects , Anticoagulants/blood , Drug Monitoring/methods , Enoxaparin/administration & dosage , Enoxaparin/adverse effects , Factor Xa Inhibitors/administration & dosage , Factor Xa Inhibitors/adverse effects , Female , Hemorrhage/prevention & control , Humans , Male , Middle Aged , Obesity, Morbid/blood , Obesity, Morbid/surgery , Pre-Exposure Prophylaxis/methods , Retrospective Studies , Sex Factors , Venous Thromboembolism/blood , Venous Thromboembolism/prevention & control
2.
Eur J Med Res ; 27(1): 21, 2022 Feb 05.
Article in English | MEDLINE | ID: covidwho-1666676

ABSTRACT

The global COVID-19 pandemic has affected the world's population by causing changes in behavior, such as social distancing, masking, restricting people's movement, and evaluating existing medication as potential therapies. Many pre-existing medications such as tocilizumab, ivermectin, colchicine, interferon, and steroids have been evaluated for being repurposed to use for the treatment of COVID-19. None of these agents have been effective except for steroids and, to a lesser degree, tocilizumab. Ivermectin has been one of the suggested repurposed medications which exhibit an in vitro inhibitory activity on SARS-CoV-2 replication. The most recommended dose of ivermectin for the treatment of COVID-19 is 150-200 µg/kg twice daily. As ivermectin adoption for COVID-19 increased, the Food and Drug Administration (FDA) issued a warning on its use during the pandemic. However, the drug remains of interest to clinicians and has shown some promise in observational studies. This narrative reviews the toxicological profile and some potential therapeutic effects of ivermectin. Based on the current dose recommendation, ivermectin appears to be safe with minimum side effects. However, serious questions remain about the effectiveness of this drug in the treatment of patients with COVID-19.


Subject(s)
Antiviral Agents/therapeutic use , COVID-19/drug therapy , Drug Repositioning , Ivermectin/adverse effects , Ivermectin/therapeutic use , Antiviral Agents/adverse effects , Antiviral Agents/pharmacokinetics , Clinical Trials as Topic , Humans , Ivermectin/administration & dosage , Ivermectin/pharmacokinetics , Pre-Exposure Prophylaxis/methods
3.
Lancet ; 397(10279): 1116-1126, 2021 03 20.
Article in English | MEDLINE | ID: covidwho-1525995

ABSTRACT

Men who have sex with men (MSM) in the USA were the first population to be identified with AIDS and continue to be at very high risk of HIV acquisition. We did a systematic literature search to identify the factors that explain the reasons for the ongoing epidemic in this population, using a social-ecological perspective. Common features of the HIV epidemic in American MSM include role versatility and biological, individual, and social and structural factors. The high-prevalence networks of some racial and ethnic minority men are further concentrated because of assortative mixing, adverse life experiences (including high rates of incarceration), and avoidant behaviour because of negative interactions with the health-care system. Young MSM have additional risks for HIV because their impulse control is less developed and they are less familiar with serostatus and other risk mitigation discussions. They might benefit from prevention efforts that use digital technologies, which they often use to meet partners and obtain health-related information. Older MSM remain at risk of HIV and are the largest population of US residents with chronic HIV, requiring culturally responsive programmes that address longer-term comorbidities. Transgender MSM are an understudied population, but emerging data suggest that some are at great risk of HIV and require specifically tailored information on HIV prevention. In the current era of pre-exposure prophylaxis and the undetectable equals untransmittable campaign, training of health-care providers to create culturally competent programmes for all MSM is crucial, since the use of antiretrovirals is foundational to optimising HIV care and prevention. Effective control of the HIV epidemic among all American MSM will require scaling up programmes that address their common vulnerabilities, but are sufficiently nuanced to address the specific sociocultural, structural, and behavioural issues of diverse subgroups.


Subject(s)
Acquired Immunodeficiency Syndrome/epidemiology , HIV Infections/epidemiology , HIV Infections/prevention & control , Homosexuality, Male/statistics & numerical data , Sexual and Gender Minorities/psychology , Acquired Immunodeficiency Syndrome/drug therapy , Adolescent , Adult , Anti-Retroviral Agents/therapeutic use , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19/psychology , COVID-19/virology , Comorbidity , HIV Infections/transmission , Humans , Incidence , Male , Middle Aged , Minority Groups/psychology , Pre-Exposure Prophylaxis/methods , Risk Factors , SARS-CoV-2/genetics , Sexual Behavior/psychology , Sexual Partners/psychology , Transgender Persons/psychology , United States/epidemiology , Young Adult
4.
Arch Sex Behav ; 51(1): 365-381, 2022 01.
Article in English | MEDLINE | ID: covidwho-1505944

ABSTRACT

In the USA, the COVID-19 pandemic has created challenges beyond the direct consequences of the infection. Because of shifting resources in response to need, many domains within the healthcare sector unrelated to COVID-19 have had interrupted abilities to provide care. In the current study, we focus on preventative sexual health care during the pandemic. In a sample of 511 (mean age = 27.7) people, we examined quantitative data regarding continuation and discontinuation of birth control and PrEP during the pandemic, along with qualitative data illustrating the underlying reasons for participants' (dis)continuation. Results showed that most (92.5%) of birth control users reported continuation of their birth control, with the predominant reasons reported being use for health reasons, long-acting reversible contraceptive use, access to remote healthcare services, and increased vigilance over pregnancy prevention. Conversely, around half (52.6%) of PrEP-using participants reported already discontinuing or planning to discontinue their PrEP regimen. Temporary abstinence and concerns about accessing in-person health care were the predominant reasons for PrEP discontinuation. These results have implications for both researchers and sexual healthcare providers. Disruptions to preventative sexual health care should be considered in ongoing research about patient needs, and healthcare providers may wish to consider particular challenges faced by PrEP users concerning re-start and continuation.


Subject(s)
COVID-19 , HIV Infections , Pre-Exposure Prophylaxis , Adult , Contraception , Female , HIV Infections/prevention & control , Humans , Pandemics , Pre-Exposure Prophylaxis/methods , Pregnancy , SARS-CoV-2
5.
Viruses ; 13(10)2021 10 13.
Article in English | MEDLINE | ID: covidwho-1470991

ABSTRACT

Different and several public health strategies have been planned to reduce transmission of pandemic due to SARS-CoV-2 since it started. None drugs have been confirmed as able to prevent viral transmission. Hydroxychloroquine with its immunomodulatory properties has been proposed as potential anti-viral drug in particular for prevention once viral exposure has been happen or in first phases of infection. Furthermore, in several immunological systemic disease hydroxychloroquine was able to reduce the number of thrombotic complications. So, because COVID-19 was associated to immunological imbalance and to thrombotic complications, we retrospectively analyzed the rate of infection in those patients being under treatment with this drug during COVID-19 epidemic outbreak from 8 March until 28 April in particular comparing those with pre-exposure to this treatment and those that were not taking this medication before SARS-CoV-2 viral infections.


Subject(s)
COVID-19/drug therapy , COVID-19/prevention & control , Hydroxychloroquine/therapeutic use , Pre-Exposure Prophylaxis/methods , Treatment Failure , Venous Thromboembolism/prevention & control , Adult , Aged , Aged, 80 and over , Antiviral Agents/therapeutic use , Female , Humans , Male , Middle Aged , Retrospective Studies , SARS-CoV-2/drug effects
7.
PLoS One ; 16(5): e0251917, 2021.
Article in English | MEDLINE | ID: covidwho-1388916

ABSTRACT

An alternative strategy for men who have sex with men (MSM) experiencing challenges with daily HIV pre-exposure prophylaxis (PrEP) includes 2-1-1 dosing. Understanding 2-1-1 PrEP facilitators and barriers, especially during the SARS-CoV-2 pandemic, may guide researchers and healthcare providers in future studies and clinical preparedness. We conducted a national cross-sectional study of MSM in the US who had taken 2-1-1 PrEP to examine facilitators and barriers of this on-demand PrEP dosing option. With the shelter-in-place orders in March 2020, this study was adapted to include questions on how the SARS-CoV-2 pandemic affected participants' PrEP use. A total of 140 individuals participated in the survey, 106 of which completed questions pertaining to the SARS-CoV-2 pandemic. The most common reasons for switching from once-daily to 2-1-1 PrEP included having sex less frequently (63.6%) and wanting to take fewer pills (46.4%). Participants reported high medication adherence based on each component of 2-1-1 PrEP dosing (>84%). The most common barriers with 2-1-1 PrEP dosing included unplanned sexual encounters resulting in missing the double-dose pre-sex (43.6%) and trouble remembering doses post-sex (29.3%). Facilitators of the 2-1-1 PrEP dosing strategy included reductions in sexual encounters (63.6%), preference to take fewer pills (46.4%), need to reduce cost (22.1%), and desire to reduce side effects (19.3%). Challenges to receiving PrEP services during the pandemic included obtaining laboratory testing (25.5%) and PrEP refills (either receipt of a refill authorization from a healthcare provider or processing of a refill from the pharmacy) (18.9%). 2-1-1 PrEP is an effective HIV prevention method; therefore, understanding facilitators and barriers of this dosing strategy can result in continuous provision of HIV prevention efforts, particularly during a pandemic.


Subject(s)
Anti-HIV Agents/therapeutic use , COVID-19 , HIV Infections/prevention & control , Homosexuality, Male , Pandemics , Pre-Exposure Prophylaxis/methods , Adult , Anti-HIV Agents/administration & dosage , Cross-Sectional Studies , Health Services Accessibility , Humans , Male , Middle Aged , Sexual Behavior , Sexual and Gender Minorities
9.
Lancet HIV ; 8(11): e723-e728, 2021 11.
Article in English | MEDLINE | ID: covidwho-1373322

ABSTRACT

Two multinational clinical trials have shown safety and efficacy of long-acting injectable cabotegravir for HIV pre-exposure prophylaxis (PrEP). These results will alter the landscape of HIV prevention and related research. Nevertheless, designing and conducting this research involved several ethical issues. This Viewpoint describes how we managed ethical issues over the duration of one of these trials (HPTN 083). Specifically, we discuss the rationale for pursuing a long-acting injectable agent in the presence of effective oral PrEP, trial design choices, site selection and local standards of prevention, data monitoring and early stopping, effects of the COVID-19 pandemic, post-trial access, and assessment of long-term safety.


Subject(s)
Anti-HIV Agents/administration & dosage , COVID-19 , HIV Infections/prevention & control , Pre-Exposure Prophylaxis/ethics , Anti-HIV Agents/adverse effects , Health Services Accessibility , Humans , Pandemics , Pre-Exposure Prophylaxis/methods , SARS-CoV-2
11.
Adv Drug Deliv Rev ; 176: 113867, 2021 09.
Article in English | MEDLINE | ID: covidwho-1312868

ABSTRACT

Prophylactic vaccines have evolved from traditional whole-cell vaccines to safer subunit vaccines. However, subunit vaccines still face problems, such as poor immunogenicity and low efficiency, while traditional adjuvants are usually unable to meet specific response needs. Advanced delivery vectors are important to overcome these barriers; they have favorable safety and effectiveness, tunable properties, precise location, and immunomodulatory capabilities. Nevertheless, there has been no systematic summary of the delivery systems to cover a wide range of infectious pathogens. We herein summarized and compared the delivery systems for major or epidemic infectious diseases caused by bacteria, viruses, fungi, and parasites. We also included the newly licensed vaccines (e.g., COVID-19 vaccines) and those close to licensure. Furthermore, we highlighted advanced delivery systems with high efficiency, cross-protection, or long-term protection against epidemic pathogens, and we put forward prospects and thoughts on the development of future prophylactic vaccines.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Communicable Diseases/therapy , Drug Delivery Systems/methods , Pre-Exposure Prophylaxis/methods , Animals , COVID-19/epidemiology , COVID-19/immunology , COVID-19 Vaccines/immunology , Communicable Diseases/epidemiology , Communicable Diseases/immunology , Epidemics/prevention & control , Humans , Liposomes , Nanoparticles/administration & dosage
12.
Eur Rev Med Pharmacol Sci ; 25(9): 3632-3639, 2021 May.
Article in English | MEDLINE | ID: covidwho-1232736

ABSTRACT

OBJECTIVE: In the current pandemic, Health Care Workers (HCWs) are at a high risk of developing COVID-19. Preventive methods like the use of personal protective equipment, isolation, social distancing, and chemoprophylaxis show limited benefit. Despite standard prophylaxis, many of the HCWs develop COVID-19. Medical ozone therapy has immunomodulatory, antioxidant and antiviral effect, and, therefore, it can be explored as prophylaxis for COVID-19. PATIENTS AND METHODS: We conducted a retrospective controlled cohort study. IV ozonized saline was administered once a day for a total of 4 days in one month in addition to standard prophylaxis for COVID-19 to HCWs in a dedicated COVID hospital. Fresh ozonized saline was prepared for every administration and was given over 1 hour. RESULTS: There were 235 HCWs, 64 received the ozone prophylaxis and 171 did not. The incidence of COVID-19 was significantly (p=0.04) lesser in HCWs that received ozone prophylaxis (4.6%) as compared to those who did not (14.03%). The benefit was seen irrespective of the risk of exposure. In the red zone, 8.69% of the HCWs who received ozone prophylaxis tested positive as opposed to 15.3% of those who did not. In the orange zone, 4.34% of the HCWs who received ozone prophylaxis tested positive, remarkably lesser than those who did not (20%). In the green zone, none of the HCWs who received ozone prophylaxis tested positive; however, 3.4% of the HCWs who did not receive ozone prophylaxis tested positive. No major adverse events were noted. CONCLUSIONS: IV ozonized saline can be used in addition to the standard prophylactic regimen for the prevention of COVID-19 in HCWs. Prospective larger studies are required to establish the potency of IV ozonized saline as prophylaxis.


Subject(s)
COVID-19/prevention & control , Health Personnel/trends , Hospitalization/trends , Ozone/administration & dosage , Pre-Exposure Prophylaxis/trends , Saline Solution/administration & dosage , Administration, Intravenous , Adult , Anti-Inflammatory Agents/administration & dosage , COVID-19/epidemiology , Cohort Studies , Female , Humans , India/epidemiology , Male , Pre-Exposure Prophylaxis/methods , Retrospective Studies , Young Adult
13.
J Med Virol ; 93(3): 1573-1580, 2021 03.
Article in English | MEDLINE | ID: covidwho-1196478

ABSTRACT

To explore the role of thymosin drugs in the prevention of novel coronavirus disease (COVID-19), we analyzed the preventive effects of different medication timings on health medical staff, and then provided recommendations for pharmaceutical monitoring of thymus drugs. The hospital-based retrospective study analyzed 435 medical staffers, treated with or without thymosin drugs as preventive medicines in our hospital of Wuhan City, from January 25 to March 25, 2020. For the prophylactics, the medical staff was prevented from pre-exposure prophylaxis (risk prevention of exposure to COVID-19 patients before using thymosin drugs) and postexposure prophylaxis (risk prevention of exposure to COVID-19 patients after using thymosin drugs). The effectiveness and safety of thymosin drugs were studied in the prevention and control of COVID-19 application, in real-world data research for the application of the drug for COVID- 19. In a similar exposure environment, compared to medical staffers who did not take preventive medicine, the use of thymosin drugs, before exposure and after exposure had an insignificant effect, and the adverse drug reaction (ADR) was increased, especially when thymosin drugs were used together with α-interferon.


Subject(s)
COVID-19/prevention & control , SARS-CoV-2/drug effects , Thymosin/therapeutic use , Adolescent , Adult , Antiviral Agents/therapeutic use , Female , Hospitals , Humans , Male , Medical Staff , Middle Aged , Pre-Exposure Prophylaxis/methods , Retrospective Studies , Young Adult
14.
Contemp Clin Trials ; 105: 106402, 2021 06.
Article in English | MEDLINE | ID: covidwho-1188374

ABSTRACT

Post-natal HIV infection through breastfeeding remains a challenge in many low and middle-income countries, particularly due to non-availability of alternative infant feeding options and the suboptimal Prevention of Mother to Child Transmission of HIV-1 (PMTCT) cascade implementation and monitoring. The PROMISE-EPI study aims to address the latter by identifying HIV infected mothers during an almost never-missed visit for their infant, the second extended program on immunization visit at 6-8 weeks of age (EPI-2). The study is divided into 3 components inclusive of an open-label randomized controlled trial aiming to assess the efficacy of a responsive preventive intervention compared to routine intervention based on the national PMTCT guidelines for HIV-1 uninfected exposed breastfeeding infants. The preventive intervention includes: a) Point of care testing for early infant HIV diagnosis and maternal viral load; b) infant, single-drug Pre-Exposure Prophylaxis (PrEP) (lamivudine) if mothers are virally unsuppressed. The primary outcome is HIV-transmission rate from EPI-2 to 12 months. The study targets to screen 37,000 mother/infant pairs in Zambia and Burkina Faso to identify 2000 mother/infant pairs for the clinical trial. The study design and challenges faced during study implementation are described, including the COVID-19 pandemic and the amended HIV guidelines in Zambia in 2020 (triple-drug PrEP in HIV exposed infants guided by quarterly maternal viral load). The changes in the Zambian guidelines raised several questions including the equipoise of PrEP options, the standard of care-triple-drug (control arm in Zambia) versus the study-single-drug (intervention arm). Trial registration number (www.clinicaltrials.gov): NCT03869944. Submission category: Study Design, Statistical Design, Study Protocols.


Subject(s)
Anti-HIV Agents/therapeutic use , Breast Feeding , HIV Infections/drug therapy , HIV Infections/transmission , Infectious Disease Transmission, Vertical/prevention & control , Lamivudine/therapeutic use , Adolescent , Adult , Anti-HIV Agents/administration & dosage , Anti-HIV Agents/adverse effects , Burkina Faso , COVID-19/epidemiology , Cross-Sectional Studies , Female , HIV Infections/diagnosis , Humans , Infant , Lamivudine/administration & dosage , Lamivudine/adverse effects , Pandemics , Pre-Exposure Prophylaxis/methods , Research Design , SARS-CoV-2 , Viral Load , Young Adult , Zambia
18.
Disaster Med Public Health Prep ; 14(3): 391-405, 2020 Jun.
Article in English | MEDLINE | ID: covidwho-1028321

ABSTRACT

Over the years, the practice of medicine has evolved from authority-based to experience-based to evidence-based with the introduction of the scientific process, clinical trials, and outcomes-based data analysis (Tebala GD. Int J Med Sci. 2018;15(12):1397-1405). The time required to perform the necessary randomized controlled trials, a systematic literature review, and meta-analysis of these trials to then create, accept, promulgate, and educate the practicing clinicians to use the evidence-based clinical guidelines is typically measured in years. When the severe acute respiratory syndrome novel coronavirus-2 (SARS-nCoV-2) pandemic commenced in Wuhan, China at the end of 2019, there were few available clinical guidelines to deploy, let alone adapt and adopt to treat the surge of coronavirus disease 2019 (COVID-19) patients. The aim of this study is to first explain how clinical guidelines, on which bedside clinicians have grown accustomed, can be created in the midst of a pandemic, with an evolving scientific understanding of the pathophysiology of the hypercoagulable state. The second is to adapt and adopt current venous thromboembolism diagnostic and treatment guidelines, while relying on the limited available observational reporting of COVID-19 patients to create a comprehensive clinical guideline to treat COVID-19 patients.


Subject(s)
Coronavirus Infections/complications , Fibrin Fibrinogen Degradation Products/analysis , Pneumonia, Viral/complications , Pre-Exposure Prophylaxis/methods , Venous Thromboembolism/etiology , Anticoagulants/therapeutic use , COVID-19 , Coronavirus Infections/drug therapy , Guidelines as Topic , Humans , Pandemics/statistics & numerical data , Pneumonia, Viral/drug therapy , Pre-Exposure Prophylaxis/standards , Pre-Exposure Prophylaxis/statistics & numerical data , Venous Thromboembolism/drug therapy , Venous Thromboembolism/prevention & control
19.
PLoS One ; 16(1): e0244778, 2021.
Article in English | MEDLINE | ID: covidwho-1013217

ABSTRACT

BACKGROUND: Populations such as healthcare workers (HCW) that are unable to practice physical distancing are at high risk of acquiring Coronavirus disease-2019 (COVID-19). In these cases pharmacological prophylaxis would be a solution to reduce severe acute respiratory syndrome coronavirus-2 (SARS CoV-2) transmission. Hydroxychloroquine has in vitro antiviral properties against SARS CoV-2. We therefore sought to determine the efficacy and safety of hydroxychloroquine as prophylaxis for COVID-19. METHODS AND FINDINGS: We electronically searched EMBASE, MEDLINE, the Cochrane COVID-19 Register of Controlled Trials, Epistemonikos COVID-19, clinicaltrials.gov, and the World Health Organization International Clinical Trials Registry Platform up to September 28th, 2020 for randomized controlled trials (RCTs). We calculated pooled relative risks (RRs) for dichotomous outcomes with the corresponding 95% confidence intervals (CIs) using a random-effect model. We identified four RCTs (n = 4921) that met our eligibility criteria. The use of hydroxychloroquine, compared to placebo, did not reduce the risks of developing COVID-19 (RR 0.82, 95% CI 0.65 to 1.04, moderate certainty), hospitalization (RR 0.72, 95% CI 0.34 to 1.50, moderate certainty), or mortality (RR 3.26, 95% CI 0.13 to 79.74, low certainty), however, hydroxychloroquine use increased the risk of adverse events (RR 2.76, 95% CI 1.38 to 5.55, moderate certainty). CONCLUSION: Although pharmacologic prophylaxis is an attractive preventive strategy against COVID-19, the current body of evidence failed to show clinical benefit for prophylactic hydroxychloroquine and showed a higher risk of adverse events when compared to placebo or no prophylaxis.


Subject(s)
COVID-19/drug therapy , Hydroxychloroquine/adverse effects , Hydroxychloroquine/therapeutic use , Antibiotic Prophylaxis/methods , Antiviral Agents/therapeutic use , COVID-19/metabolism , Humans , Hydroxychloroquine/metabolism , Pre-Exposure Prophylaxis/methods , Randomized Controlled Trials as Topic , SARS-CoV-2/pathogenicity
20.
Intern Emerg Med ; 16(5): 1223-1229, 2021 08.
Article in English | MEDLINE | ID: covidwho-1002167

ABSTRACT

We conducted an observational cohort study in adult patients consecutively admitted for the respiratory illness Covid-19 to our hub hospital from March 9 to April 7, 2020. The high observed rate of venous thromboembolism prompted us to increase the prophylactic doses of enoxaparin from 40 mg daily up to 1 mg/kg twice daily in patients admitted to intensive care units (ICU), 0.7 mg/kg twice daily in high-intensity of care wards and 1 mg/kg daily in low-intensity of care wards. Patients on high enoxaparin doses were compared to those who received prophylaxis with the standard dosage. Efficacy endpoints were mortality, clinical deterioration, and the occurrence of venous thromboembolism, safety endpoint was the occurrence of major bleeding. Of 278 patients with Covid-19, 127 received prophylaxis with high enoxaparin doses and 151 with standard dosage. At 21 days, the incidence rate of death and clinical deterioration were lower in patients on higher doses than in those on the standard dosage (hazard ratio 0.39, 95% confidence interval 0.23-0.62), and the incidence of venous thromboembolism was also lower (hazard ratio 0.52, 95% confidence interval 0.26-1.05). Major bleeding occurred in four of 127 patients (3.1%) on the high enoxaparin dosage. In conclusion, in the cohort of patients with Covid-19 treated with high enoxaparin dosages we observed a 60% reduction of mortality and clinical deterioration and a 50% reduction of venous thromboembolism compared to standard dosage prophylaxis. However, 3% of patients on high enoxaparin dosages had non-fatal major bleeding.


Subject(s)
COVID-19/drug therapy , Heparin, Low-Molecular-Weight/administration & dosage , Hospitalization/statistics & numerical data , Pre-Exposure Prophylaxis/classification , Aged , Body Mass Index , COVID-19/mortality , Cohort Studies , Enoxaparin/administration & dosage , Enoxaparin/classification , Female , Heparin, Low-Molecular-Weight/classification , Humans , Male , Middle Aged , Pre-Exposure Prophylaxis/methods , Pre-Exposure Prophylaxis/statistics & numerical data , Venous Thromboembolism/prevention & control
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