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3.
researchsquare; 2022.
Preprint in English | PREPRINT-RESEARCHSQUARE | ID: ppzbmed-10.21203.rs.3.rs-2015733.v1

ABSTRACT

Introduction COVID-19 vaccines have been highly effective in reducing morbidity and mortality during the pandemic. However, the emergence of the Omicron (B.1.1.529) variant and subvariants as the globally dominant strains have raised doubts about the effectiveness of currently-available vaccines and prompted debate about potential future vaccination strategies.Areas covered Using the publicly available IVAC VIEW-hub platform, we reviewed 52 studies on vaccine effectiveness (VE) after booster vaccinations. VE data were reported for SARS-CoV-2 symptomatic infection, severe disease and death and stratified by vaccine schedule and age. In addition, a non-systematic literature review of safety was performed to identify single or multi-country studies investigating adverse event rates for at least two of the currently-available COVID-19 vaccines.Expert opinion Booster shots of the current COVID-19 vaccines provide consistently high protection against Omicron-related severe disease and death. Additionally, this protection appears to be conserved for at least 3 months, with a small but significant waning after that time. The positive risk-benefit ratio of these vaccines is well established, thus increasing confidence in administering additional doses as required. Future vaccination strategies will likely include a combination of schedules based on a person’s risk profile, as overly frequent boosting may be neither beneficial nor sustainable for the general population.


Subject(s)
COVID-19
4.
medrxiv; 2021.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2021.07.06.21260085

ABSTRACT

ABSTRACT BACKGROUND The effectiveness of rosuvastatin plus colchicine, emtricitabine/tenofovir, and of their combined use in hospitalized patients with coronavirus disease 2019 (Covid-19) pneumonia is unclear. METHODS In each hospital, hospitalized adults with Covid-19 pneumonia, were randomly assigned, in a 1:1 ratio, to receive: a) standard of care; or b) emtricitabine/tenofovir; or c) colchicine + rosuvastatin; or d) emtricitabine/tenofovir + colchicine + rosuvastatin. The primary outcome was all-cause mortality within the first 28 days after randomization. Severe adverse events (SAE) were those with a high probability of being treatment-related. RESULTS 633 patients were randomized in 6 hospitals in Bogota, Colombia. Overall, 98% of the patients received glucocorticoids during hospitalization. The cumulative incidence of death through day 28 was 10.7% in the emtricitabine/tenofovir + colchicine + rosuvastatin arm, 14.4% in the colchicine + rosuvastatin arm, 13.8% in the emtricitabine/tenofovir arm, and 17.4% in the standard of care arm, with adjusted risk differences (aRD) against the standard treatment of -0.07 (95% confidence interval [CI], -0.17 to 0.04), aRD -0.03 (95%CI: -0.11 to 0.05) and aRD: -0.05 (95%CI: -0.15 to 0.05), respectively. Need for invasive mechanical ventilation was lower in the emtricitabine/tenofovir + colchicine + rosuvastatin arm compared to the standard treatment arm, aRD: -0.06 (95%CI: -0.11 to -0,01), but no differences were found between the other comparisons. SAE occurred in 3 patients distributed in the 3 treatment arms. CONCLUSIONS Among patients hospitalized with moderate and severe SARS Covid-19, the use of the emtricitabine/tenofovir + colchicine + rosuvastatin combination emerges as a treatment alternative. ClinicalTrials.gov number: NCT04359095


Subject(s)
COVID-19 , Pneumonia
5.
medrxiv; 2021.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2021.06.17.21259078

ABSTRACT

Background The unprecedented public health impact of the COVID-19 pandemic has motivated a rapid search for potential therapeutics, with some key successes. However, the potential impact of different treatments, and consequently research and procurement priorities, have not been clear. Methods and Findings We develop a mathematical model of SARS-CoV-2 transmission, COVID-19 disease and clinical care to explore the potential public-health impact of a range of different potential therapeutics, under a range of different scenarios varying: i) healthcare capacity, ii) epidemic trajectories; and iii) drug efficacy in the absence of supportive care. In each case, the outcome of interest was the number of COVID-19 deaths averted in scenarios with the therapeutic compared to scenarios without. We find the impact of drugs like dexamethasone (which are delivered to the most critically-ill in hospital and whose therapeutic benefit is expected to depend on the availability of supportive care such as oxygen and mechanical ventilation) is likely to be limited in settings where healthcare capacity is lowest or where uncontrolled epidemics result in hospitals being overwhelmed. As such, it may avert 22% of deaths in high-income countries but only 8% in low-income countries (assuming R=1.35). Therapeutics for different patient populations (those not in hospital, early in the course of infection) and types of benefit (reducing disease severity or infectiousness, preventing hospitalisation) could have much greater benefits, particularly in resource-poor settings facing large epidemics. Conclusions There is a global asymmetry in who is likely to benefit from advances in the treatment of COVID-19 to date, which have been focussed on hospitalised-patients and predicated on an assumption of adequate access to supportive care. Therapeutics that can feasibly be delivered to those earlier in the course of infection that reduce the need for healthcare or reduce infectiousness could have significant impact, and research into their efficacy and means of delivery should be a priority.


Subject(s)
COVID-19
6.
ssrn; 2021.
Preprint in English | PREPRINT-SSRN | ID: ppzbmed-10.2139.ssrn.3817420

ABSTRACT

Background: The unprecedented public health impact of the COVID-19 pandemic has motivated a rapid search for potential therapeutics, with some key successes. However, the potential impact of current and proposed treatments, and consequently research and procurement priorities, have not been clear. Methods: First, we used a model of SARS-CoV-2 transmission, COVID-19 disease and clinical care pathways to explore the potential impact of dexamethasone - the main treatment currently for hospitalised COVID-19 patients - under scenarios varying: i) healthcare capacity, ii) epidemic trajectories; and iii) the efficacy of dexamethasone in the absence of supportive care. We then fit the model to the observed epidemic trajectory to-date in 165 countries and analysed the potential future impact of dexamethasone in different countries, regions, and country-income strata. Finally, we constructed hypothetical profiles of novel therapeutics based on current trials, and compared the potential impact of each under different circumstances. In each case, the outcome of interest was the number of COVID-19 deaths averted in scenarios with the therapeutic compared to scenarios without. Findings: We find the potential benefit dexamethasone is severely limited in settings where healthcare capacity is lowest or where uncontrolled epidemics result in hospitals being overwhelmed. As such, it may avert 22% of deaths in high-income countries but only 8% in low-income countries (assuming R=1.35). However, therapeutics for different patient populations (in particular, those not in hospital and early in the course of infection) and types of benefit (in particular, reducing disease severity or infectiousness) could have much greater benefits. Such therapeutics would have particular value in resource-poor settings facing large epidemics, even if the efficacy or achievable coverage of such therapeutics is lower in comparison to other types. Interpretation: People in low-income countries will benefit the least from advances in the treatment of COVID-19 to date, which have focussed on hospitalised-patients with adequate access to supportive care. Therapeutics that can feasibly be delivered to those earlier in the course of infection that reduce the need for healthcare or reduce infectiousness could have much greater impact. Such therapeutics may be feasible and research into their efficacy and means of delivery should be a priority. Funding: None to declare. Declaration of Interest: None to declare.


Subject(s)
COVID-19
7.
researchsquare; 2020.
Preprint in English | PREPRINT-RESEARCHSQUARE | ID: ppzbmed-10.21203.rs.3.rs-91961.v1

ABSTRACT

Background: The COVID-19 (Coronavirus disease 2019) pandemic is the largest global event of recent times, leaving millions infected and hundreds of thousands of dead worldwide. Colombia is no stranger to this situation, being subject to massive cancellations of medically necessary surgical procedures categorized as ¨non vital¨. The objective of this study is to show the results of a program of elective essential and non-essential low and medium complexity orthopedic surgeries performed during the mitigation phase of the COVID-19 pandemic with a pre-surgical clinical protocol, without serological or molecular testing, during April, 2020 in two institutions in Bogotá, Colombia. Method: ology ​ :​ A multicenter, observational, retrospective, descriptive study of a cohort of patients who underwent elective orthopedic surgery at two institutions in the city of Bogota, Colombia, during April 2020. We performed a preoperative clinical protocol without including serological or molecular tests, an epidemiological survey, describing the type of surgery, their score in the MeNTs (medically necessary time sensitive) scale, and the presence of suggestive symptoms of COVID-19 postoperatively. Results: ​ :​ A total of 179 patients underwent orthopedic surgery with an average age of 47 years (swilk= 0.021) (Shapiro-Wilk) ranging between 18 and 81 years, with a majority of females (61.5%). As for the surgeries, 86 (48%) were knee operations, 42 (23.5%) hand surgeries, 34 (19%) shoulder surgeries, and 17 (9.5%) foot and ankle surgeries. The average MeNTS of all patients was 44.6 points. During the two weeks after surgery, four patients were considered suspects for COVID-19 for presenting at least two symptoms associated with the disease representing an incidence of 2.3%. Two (1.1%) of these four patients consulted an emergency department where RT-PCR(reverse transcription polymerase chain reaction) type tests were performed, obtaining a negative result for SARSCov-2 (severe acute respiratory syndrome Coronavirus-2). No patients died or were hospitalized for symptoms associated with COVID-19. Conclusion: ​ :​ Through the implementation of a pre-surgical clinical protocol (physical examination, clinical survey inquiring about signs, symptoms and epidemiological contacts), a pre-surgical isolation and without the performance of molecular or serological diagnostic tests, the present study showed good results in the performance of low and medium complexity elective orthopedic surgery at an early stage of the COVID-19 pandemic. Level of evidence ​ :​ IV.


Subject(s)
COVID-19 , Coronavirus Infections
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