Monoclonal antibody treatment of symptomatic COVID-19 in pregnancy: initial report.
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ABSTRACT:
SUBMITTER: Hirshberg JS
PROVIDER: S-EPMC8386136 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Solid organ transplant (SOT) recipients are at high risk for severe coronavirus disease 2019 (COVID-19). Studies suggest that early intervention with monoclonal antibody (MAB) treatment directed against the SARS-CoV-2 spike protein may reduce the risk of emergency department visits or hospitalization for COVID-19, especially in high-risk patients. Herein, we describe our single-center experience of 93 SOT (50 kidney, 17 liver, 11 lung, nine heart, and six dual-organ) recipients with mild to moderate COVID-19 who were treated with bamlanivimab or casirivimab-imdevimab per emergency use authorization guidelines. Median age of recipients was 55 [(Interquartile range) 44-63] years, and 41% were diabetic. Median time from transplant to MAB was 64 (IQR 24-122) months and median time from the onset of COVID-19 symptoms to the infusion was 6 (IQR 4-7) days. All patients had a minimum 30 days of study follow-up. The 30-day hospitalization rate for COVID-19-directed therapy was 8.7%. Infusion-related adverse events were rare and generally mild. Biopsy-proven organ rejection occurred in two patients, and there were no graft losses or deaths. A comparator group of 72 SOT recipients diagnosed with COVID-19 who were eligible but did not receive MAB treatment had a higher 30-day hospitalization rate for COVID-19-directed therapy (15.3%), although this difference was not statistically significant, after adjustment for age (Odds Ratio 0.49 [95% Confidence Interval 0.18-1.32], p = 0.16). Our experience suggests that MAB treatment, with respect to the available MAB formulations and circulating viral variants present during our study period, may provide favorable outcomes for mild to moderate COVID-19 in SOT recipients.
| S-EPMC8646855 | biostudies-literature
Project description:Currently clinicians all around the world are experiencing a pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The clinical presentation of this pathology includes fever, dry cough, fatigue and acute respiratory distress syndrome that can lead to death infected patients. Current studies on coronavirus disease 2019 (COVID-19) continue to highlight the urgent need for an effective therapy. Numerous therapeutic strategies have been used until now but, to date, there is no specific effective treatment for SARS-CoV-2 infection. Elevated inflammatory cytokines have been reported in patients with COVID-19. Evidence suggests that elevated cytokine levels, reflecting a hyperinflammatory response secondary to SARS-CoV-2 infection, are responsible for multi-organ damage in patients with COVID-19. For these reason, numerous randomized clinical trials are currently underway to explore the effectiveness of biopharmaceutical drugs, such as, interleukin-1 blockers, interleukin-6 inhibitors, Janus kinase inhibitors, in COVID-19. The aim of the present paper is to briefly summarize the pathogenetic rationale and the state of the art of therapeutic strategy blocking hyperinflammation.
| S-EPMC7559676 | biostudies-literature
Project description:Abstract Background The Coronavirus disease 2019 (COVID-19) pandemic has led to the rapid development of COVID-19 vaccine. The Centers for Disease Control and Prevention (CDC) has recently reported increase in myopericarditis incidence post-COVID-19 vaccination. Post-vaccination myopericarditis as side effect has been reported, however, is infrequent. We described a case of pericarditis post-first dose of Pfizer-BioNTech vaccine. Case summary A patient presented with typical symptoms of pericarditis and related electrocardiogram and echocardiogram changes, 7 days post receiving the first dose of COVID-19 vaccine. No other causes were identified from series of investigations. Patient had good symptomatic relief with non-steroidal anti-inflammatory medication. Discussion The incidence of pericarditis post-vaccination is rare, with limited reporting in previous literatures. No causal relationship has yet to be established due to small number of cases. The benefits of COVID-19 vaccination currently outweigh the side effect profile and are recommended as the first-line approach to control the current pandemic.
| S-EPMC8522432 | biostudies-literature
Project description:Breakthrough COVID-19 may occur in fully vaccinated persons. In this cohort of 1395 persons (mean age, 54.3 years; 60% female; median body mass index, 30.7) who developed breakthrough COVID-19, there were 107 (7.7%) who required hospitalization by day 28. Hospitalization was significantly associated with the number of medical comorbidities. Anti-spike monoclonal antibody treatment was significantly associated with a lower risk of hospitalization (Odds Ratio: 0.227; 95% confidence interval, 0.128 - 0.403; p<0.001). The number needed to treat (NNT) to prevent one hospitalization was 225 among the lowest-risk patient group compared to NNT of 4 among those with highest numbers of medical comorbidity.
| S-EPMC8767864 | biostudies-literature
Project description:BackgroundLY-CoV555, a neutralizing monoclonal antibody, has been associated with a decrease in viral load and the frequency of hospitalizations or emergency department visits among outpatients with coronavirus disease 2019 (Covid-19). Data are needed on the effect of this antibody in patients who are hospitalized with Covid-19.MethodsIn this platform trial of therapeutic agents, we randomly assigned hospitalized patients who had Covid-19 without end-organ failure in a 1:1 ratio to receive either LY-CoV555 or matching placebo. In addition, all the patients received high-quality supportive care as background therapy, including the antiviral drug remdesivir and, when indicated, supplemental oxygen and glucocorticoids. LY-CoV555 (at a dose of 7000 mg) or placebo was administered as a single intravenous infusion over a 1-hour period. The primary outcome was a sustained recovery during a 90-day period, as assessed in a time-to-event analysis. An interim futility assessment was performed on the basis of a seven-category ordinal scale for pulmonary function on day 5.ResultsOn October 26, 2020, the data and safety monitoring board recommended stopping enrollment for futility after 314 patients (163 in the LY-CoV555 group and 151 in the placebo group) had undergone randomization and infusion. The median interval since the onset of symptoms was 7 days (interquartile range, 5 to 9). At day 5, a total of 81 patients (50%) in the LY-CoV555 group and 81 (54%) in the placebo group were in one of the two most favorable categories of the pulmonary outcome. Across the seven categories, the odds ratio of being in a more favorable category in the LY-CoV555 group than in the placebo group was 0.85 (95% confidence interval [CI], 0.56 to 1.29; P?=?0.45). The percentage of patients with the primary safety outcome (a composite of death, serious adverse events, or clinical grade 3 or 4 adverse events through day 5) was similar in the LY-CoV555 group and the placebo group (19% and 14%, respectively; odds ratio, 1.56; 95% CI, 0.78 to 3.10; P?=?0.20). The rate ratio for a sustained recovery was 1.06 (95% CI, 0.77 to 1.47).ConclusionsMonoclonal antibody LY-CoV555, when coadministered with remdesivir, did not demonstrate efficacy among hospitalized patients who had Covid-19 without end-organ failure. (Funded by Operation Warp Speed and others; TICO ClinicalTrials.gov number, NCT04501978.).
| S-EPMC7781100 | biostudies-literature
Project description:BackgroundHealthcare workers were prioritized for COVID-19 vaccination roll-out because of the high occupational risk. Vaccine trials excluded individuals who were trying to conceive and those who are pregnant and lactating, necessitating vaccine decision-making in the absence of data specific to this population.ObjectiveThis study aimed to determine the initial attitudes about COVID-19 vaccination in pregnancy-capable healthcare workers by reproductive status and occupational exposure.Study designWe performed a structured survey distributed via social media of US-based healthcare workers involved in patient care since March 2020 who were pregnancy-capable (biologic female sex without history of sterilization or hysterectomy) from January 8, 2021 to January 31, 2021. Participants were asked about their desire to receive the COVID-19 vaccine and their perceived safety of the COVID-19 vaccine using 5-point Likert items with 1 corresponding to "I strongly don't want the vaccine" or "very unsafe for me" and 5 corresponding to "I strongly want the vaccine" or "very safe for me." We categorized participants into the following 2 groups: (1) reproductive intent (preventing pregnancy vs attempting pregnancy, currently pregnant, or currently lactating), and (2) perceived COVID-19 occupational risk (high vs low). We used descriptive statistics to characterize the respondents and their attitudes about the vaccine. Comparisons between reproductive and COVID-19 risk groups were conducted using Mann-Whitney U tests.ResultsOur survey included 11,405 pregnancy-capable healthcare workers: 51.3% were preventing pregnancy (n=5846) and 48.7% (n=5559) were attempting pregnancy, currently pregnant, and/or lactating. Most respondents (n=8394, 73.6%) had received a vaccine dose at the time of survey completion. Most participants strongly desired vaccination (75.3%) and very few were strongly averse (1.5%). Although the distribution of responses was significantly different between respondents preventing pregnancy and those attempting conception or were pregnant and/or lactating and also between respondents with a high occupational risk and those with a lower occupational risk of COVID-19, the effect sizes were small and the distribution was the same for each group (median, 5; interquartile range, 4-5).ConclusionMost of the healthcare workers desired vaccination. Negative feelings toward vaccination were uncommon but were significantly higher among those attempting pregnancy and those who are pregnant and lactating and also among those with a lower perceived occupational risk of contracting COVID-19, although the effect size was small. Understanding healthcare workers' attitudes toward vaccination may help guide interventions to improve vaccine education and uptake in the general population.
| S-EPMC8692248 | biostudies-literature
Project description:Several neutralizing monoclonal antibodies (mAbs) to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been developed and are now under evaluation in clinical trials. With the US Food and Drug Administration recently granting emergency use authorizations for neutralizing mAbs in non-hospitalized patients with mild-to-moderate COVID-19, there is an urgent need to discuss the broader potential of these novel therapies and to develop strategies to deploy them effectively in clinical practice, given limited initial availability. Here, we review the precedent for passive immunization and lessons learned from using antibody therapies for viral infections such as respiratory syncytial virus, Ebola virus and SARS-CoV infections. We then focus on the deployment of convalescent plasma and neutralizing mAbs for treatment of SARS-CoV-2. We review specific clinical questions, including the rationale for stratification of patients, potential biomarkers, known risk factors and temporal considerations for optimal clinical use. To answer these questions, there is a need to understand factors such as the kinetics of viral load and its correlation with clinical outcomes, endogenous antibody responses, pharmacokinetic properties of neutralizing mAbs and the potential benefit of combining antibodies to defend against emerging viral variants.
| S-EPMC8054133 | biostudies-literature
Project description:Disparities in access to anti-SARS-CoV-2 monoclonal antibodies have not been well characterized. We sought to explore the impact of race/ethnicity as a social construct on monoclonal antibody delivery. Following implementation of a centralized infusion program at a large academic healthcare system, we reviewed a random sample of high-risk ambulatory adult patients with COVID-19 referred for monoclonal antibody therapy. We examined the relationship between treatment delivery, race/ethnicity, and other demographics using descriptive statistics, binary logistic regression, and spatial analysis. There was no significant difference in racial composition between patients who did (n = 25) and patients who did not (n = 378) decline treatment (p = 0.638). Of patients who did not decline treatment, 64.8% identified as White, 14.8% as Hispanic/Latinx, and 11.1% as Black. Only 44.6% of Hispanic/Latinx and 31.0% of Black patients received treatment compared to 64.1% of White patients (OR 0.45, 95% CI 0.25-0.81, p = 0.008, and OR 0.25, 95% CI 0.12-0.50, p < 0.001, respectively). In multivariable analysis including age, race, insurance status, non-English primary language, county Social Vulnerability Index, illness severity, and total number of comorbidities, associations between receiving treatment and Hispanic/Latinx or Black race were no longer statistically significant (AOR 1.32, 95% CI 0.69-2.53, p = 0.400, and AOR 1.34, 95% CI 0.64-2.80, p = 0.439, respectively). However, patients who were uninsured or whose primary language was not English were less likely to receive treatment (AOR 0.16, 95% CI 0.03-0.88, p = 0.035, and AOR 0.37, 95% CI 0.15-0.90, p = 0.028, respectively). Spatial analysis suggested decreased monoclonal antibody delivery to Cook County patients residing in socially vulnerable communities. High-risk ambulatory patients with COVID-19 who identified as Hispanic/Latinx or Black were less likely to receive monoclonal antibody therapy in univariate analysis, a finding not explained by patient refusal. Multivariable and spatial analyses suggested insurance status, language, and social vulnerability contributed to racial disparities.
| S-EPMC9037582 | biostudies-literature
Project description:With the number of Coronavirus Disease 2019 (COVID-19) cases soaring worldwide and limited vaccine availability for the general population in most countries, the monoclonal antibody (mAb) remains a viable therapeutic option to treat COVID-19 disease and its complications, especially in the elderly individuals. More than 50 monoclonal antibody-related clinical trials are being conducted in different countries around the world, with few of them nearing the completion of the third and fourth phase clinical trial. In view of recent emergency use authorization (EUA) from the FDA (Food and Drug Administration) of casirivimab and imdevimab, it is of importance that mAbs, already used to treat diseases such as Ebola and respiratory syncytial virus (RSV) infection, are discussed in scientific communities. This brief review discusses the mechanism of action and updates to clinical trials of different monoclonal antibodies used to treat COVID-19, with special attention paid to SARS-CoV-2 immune response in host cells, target viral structures, and justification of developing mAbs following the approval and administration of potential effective vaccine among vulnerable populations in different countries.
| S-EPMC7872849 | biostudies-literature
Project description:BackgroundBamlanivimab and casirivimab-imdevimab are authorized for emergency use treatment of mild to moderate coronavirus disease 2019 (COVID-19) in patients at high risk for developing severe disease or hospitalization. Their safety and efficacy have not been specifically evaluated in solid organ transplant recipients.MethodsWe retrospectively reviewed solid organ transplant recipients who received monoclonal antibody infusion for COVID-19 at Mayo Clinic sites through January 23, 2021. Outcomes included emergency department visit, hospitalization, mortality, and allograft rejection.ResultsSeventy-three patients were treated, most commonly with bamlanivimab (75.3%). The median age was 59 years, 63% were male, and the median Charlson comorbidity index was 5. Transplant type included 41 kidney (56.2%), 13 liver (17.8%), 11 heart (15.1%), 4 kidney-pancreas (5.5%), 2 lung (2.7%), 1 heart-liver, and 1 pancreas. Eleven (15.1%) patients had an emergency department visit within 28 days of infusion, including 9 (12.3%) who were hospitalized for a median of 4 days. One patient required intensive care unit admission for a nonrespiratory complication. No patients required mechanical ventilation, died, or experienced rejection. Ten adverse events occurred, with 1 seeking medical evaluation. Hypertension was associated with hospital admission (P < .05), while other baseline characteristics were similar. The median time from symptom onset to antibody administration was 4 days in nonhospitalized patients compared with 6 days among hospitalized patients (P < .05).ConclusionsMonoclonal antibody treatment has favorable outcomes with minimal adverse effects in solid organ transplant recipients with mild to moderate COVID-19. Earlier administration of monoclonal antibody therapy appears to be more efficacious.
| S-EPMC8494079 | biostudies-literature