Monoclonal antibody treatment of symptomatic COVID-19 in pregnancy: initial report.
Ontology highlight
ABSTRACT:
SUBMITTER: Hirshberg JS
PROVIDER: S-EPMC8386136 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:As the COVID-19 pandemic persists, pregnant women have been increasingly affected worldwide. Women during the last trimester of pregnancy are susceptible to severe COVID-19, and there are many challenges towards its treatment. Monoclonal antibody treatment (MAT) is approved for COVID-19 patients to reduce disease severity. However, there are few reports on the MAT in perinatal women. Herein, we report a 39-year-old pregnant female (36 weeks and 6 days of gestation) with improvement in COVID-19 pneumonia after treatment with casiribimab/imdevimab, resulting in successful vaginal delivery (a 2.868 kg male newborn), along with a literature review. Early diagnosis and treatment of pregnant women with COVID-19 are important. Infectious diseases doctors and/or obstetricians should be aware of the MAT option administered to perinatal COVID-19 women to reduce disease severity.
| S-EPMC8898669 | biostudies-literature
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:Multiple monoclonal antibodies have been shown to be effective for both prophylaxis and therapy for SARS-CoV-2 infection. Here we aggregate data from randomized controlled trials assessing the use of monoclonal antibodies (mAb) in preventing symptomatic SARS-CoV-2 infection. We use data on the in vivo concentration of mAb and the associated protection from COVID-19 over time to model the dose-response relationship of mAb for prophylaxis. We estimate that 50% protection from COVID-19 is achieved with a mAb concentration of 96-fold of the in vitro IC50 (95% CI: 32-285). This relationship provides a tool for predicting the prophylactic efficacy of new mAb and against SARS-CoV-2 variants. Finally, we compare the relationship between neutralization titer and protection from COVID-19 after either mAb treatment or vaccination. We find no significant difference between the 50% protective titer for mAb and vaccination, although sample sizes limited the power to detect a difference.
| S-EPMC10382502 | 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: Not available
| S-EPMC9686231 | biostudies-literature
Project description:BackgroundBreakthrough coronavirus disease 2019 (COVID-19) may occur in fully vaccinated persons.MethodsWe assessed the clinical outcomes of breakthrough COVID-19 in fully vaccinated individuals.ResultsIn 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. Antispike monoclonal antibody treatment was significantly associated with a lower risk of hospitalization (odds ratio, 0.227; 95% confidence interval, 0.128-0.403; P < .001). The number needed to treat (NNT) to prevent 1 hospitalization was 225 among the lowest risk patient group compared with NNT of 4 among those with highest numbers of medical comorbidity.ConclusionsMonoclonal antibody treatment is associated with reduced hospitalization in vaccinated high-risk persons with mild to moderate COVID-19.
| 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:IntroductionShoulder pathology may be symptomatic or asymptomatic depending on the patient. We report the first case of a COVID-19 vaccination administration precipitating symptomatic calcific tendinitis from pre-existing, asymptomatic calcific tendinitis.Case presentationA 50-year-old Thai male began experiencing left shoulder pain about 3 hours following a COVID-19 vaccination. He waited at home for the pain to improve, and when it did not improve in about 3 days he decided to see a doctor at the orthopedics clinic. He was sent for ultrasonography of his shoulder, which revealed calcific tendinitis of the subscapularis tendon.DiscussionA SIRVA is normally considered if post-vaccination shoulder pain has not improved within a few days following a vaccination in a patient without shoulder pain prior to the vaccination. In our patient, a COVID-19 vaccination precipitated asymptomatic calcific tendinitis to symptomatic calcific tendinitis.ConclusionPreviously asymptomatic shoulder pathologies can be precipitated to symptomatic by a COVID-19 vaccination.
| S-EPMC8817452 | 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