A Randomized Trial of Ivermectin 600 Mcg/Kg Vs Placebo in Mild/ Moderate Covid-19

Background: Whether ivermectin, with a maximum targeted dose of 600 mug/ kg, shortens symptom duration or prevents hospitalization among outpatients with mild to moderate coronavirus disease 2019 (COVID-19) remains unknown. Our objective was to evaluate the effectiveness of ivermectin, maximum targeted dose of 600 mug/kg, daily for 6 days compared with placebo for the treatment of early mild to moderate COVID-19. Method(s): ACTIV-6, an ongoing, decentralized, randomized, double-blind, placebo-controlled, platform trial, was designed to evaluate repurposed therapies in outpatients with mild to moderate COVID-19. A total of 1206 participants age >=30 years with confirmed COVID-19, experiencing >=2 symptoms of acute infection for <=7 days, were enrolled from February 16, 2022, through July 22, 2022, with follow-up data through November 10, 2022, at 93 sites in the US. Participants were randomized to receive ivermectin, with a maximum targeted dose of 600 mug/kg (n=602), daily vs placebo daily (n=604) for 6 days. The primary outcome was time to sustained recovery, defined as at least 3 consecutive days without symptoms. The 7 secondary outcomes included a composite of hospitalization, death, or urgent/emergent care utilization by day 28. Result(s): Among 1206 randomized participants who received study medication or placebo, median (interquartile range) age was 48 (38-58) years;713 (59%) were women;and 1008 (84%) reported >=2 SARS-CoV-2 vaccine doses. Median time to recovery was 11 (11-12) days in the ivermectin group and 11 (11-12) days in the placebo group. The hazard ratio (HR) (95% credible interval [CrI], posterior probability of benefit) for improvement in time to recovery was 1.02 (0.92-1.13;P[HR >1]=0.68). In those receiving ivermectin, 34 (5.7%) were hospitalized, died, or had urgent or emergency care visits compared with 36 (6.0%) receiving placebo (HR 1.0, 0.6-1.5;P[HR< 1]=0.53). In the ivermectin group, 1 participant died and 4 were hospitalized (0.8%);2 participants (0.3%) were hospitalized in the placebo group and there were no deaths. Adverse events were uncommon in both groups. Conclusion(s): Among outpatients with mild to moderate COVID-19, treatment with ivermectin, with a maximum targeted dose of 600 mug/kg daily for 6 days, compared with placebo did not improve time to recovery. These findings do not support the use of ivermectin in patients with mild to moderate COVID-19. Primary and secondary outcomes.

A novel cystic fibrosis-pregnancy service: Two-year review after introduction of elexacaftor/tezacaftor/ivacaftor

Background: As a quality service improvement response since elexacaftor/ tezacaftor/ivacaftor (ELX/TEZ/IVA) became available and the yearly average number of cystic fibrosis (CF) pregnancies (n = 7 pre-2020, n = 33 in 2021) increased significantly at an adult CF center (~600 people with CF), a monthly multidisciplinary CF-maternal health virtual clinic was established with antenatal virtual CF exercise classes dedicated to providing adaptive, specialist support to this cohort, aswell as outreach guidance and education to local obstetric teams. Method(s): This was a single-center retrospective reviewof Royal Brompton Hospital CF-Maternal Health multidisciplinary team clinic records and a patient survey from March 2020 to March 2022. Result(s): Of 47 pregnancies in 41 women (median age 30;) eligible for ELX/ TEZ/IVA at start of pregnancy, 40% (n = 19) were unplanned, and 19% (n = 9) used assisted conception. Three women with a history of infertility conceived naturally, having required assisted conception for previous pregnancies, and five women had multiple pregnancies during the study period. ELX/TEZ/IVA was continued in 60% (n = 28), delayed in 28% (n = 13), and stopped in 13% (n = 6) of pregnancies through maternal choice and careful clinical counselling. Pre-pregnancy pulmonary status was poorer in women who continued than in those who delayed or stopped (Table 1). Of those who stopped, 85% (n = 5) restarted because of pulmonary deterioration by the third trimester. Prenatal CF complications included at least one episode of minor hemoptysis in 21% (n = 9/41) of women, at least one infective exacerbation in 55% of pregnancies (n = 26/47), and noninvasive ventilation in one woman. Other pregnancy-associated complications included one case of ovarian hyperstimulation syndrome, one case of sub-segmental pulmonary embolism, and two cases of pregnancy-induced hypertension. Excluding 10 first trimester terminations, 10 current pregnancies, and one patient relocation, obstetric outcomes available for 26 pregnancies confirmed a live birth rate of 85% (n = 22/26) and a 15% first-trimester miscarriage rate (n = 4). Obstetric complications included preterm delivery rate of 23% (n = 6/26), including two cases of COVID infection resulting in two neonatal intensive care unit admissions, one case of endometritis after cesarean section, and a fourthdegree perineal tear. There were no ectopic pregnancies, maternal or neonatal deaths, or reports of infant cataracts or congenital malformations. Median gestational age was 37/40 weeks (range 29-40). Mode of delivery was via cesarean section in 45% (n = 10/22, of which twowere emergency) and vaginal in 55% (n = 12/22), of which 83% (n = 10/12) were via induction of labor for diabetes (CF or gestational) indication. Deliveries were supported and occurred equally at local obstetric units and in tertiarycare obstetric hospital settings (50%, n = 11/22). Patient-experience survey responses cited high levels of confidence in health optimization and prioritization during pregnancy and praised excellent inter-health care provider communication and peer-to-peer emotional support provided among expectant mothers in the virtual prenatal exercise groups. Table 1. Baseline demographic and clinical characteristics of elexacaftor/tezacaftor/ivacaftoreligible expectant mothers according to therapeutic decision (Table Presented) Conclusion(s): In the absence of clinical trial safety data, the novel approach of a dedicated CF-maternal health multidisciplinary team clinic with local obstetric outreach support has ensured regular specialist clinical and emotional peer-to-peer support for this cohort of women eligible for ELX/ TEZ/IVA to ensure optimal outcomes and experiences of their pregnancies, where appropriate, close to home.Copyright © 2022, European Cystic Fibrosis Society. All rights reserved

Asymptomatic COVID-19 is common in people living with HIV

WATERLIT : A sub-study in about one-third of participants in the international REPRIEVE trial reported COVID-19 infections from April 2020 in approximately 13%. Of these, roughly 60% were asymptomatic

Longest COVID-19 infection lasted 505 days in an immunocompromised person in London

WATERLIT : A UK study of nine group people with significantly reduced immune protection and extended COVID-19 infections, managed at Guy's and St Thomas's NHS Trust in London, includes the longest active infection reported globally to date

Melatonin does not protect against SARS-CoV-2

WATERLIT : Results from a randomised study reported no benefit of daily oral melatonin (2 mg QD) for 12 weeks compared to placebo as prophylaxis against SARS-CoV-2 in 314 Spanish health workers

HIV vaccine study using mRNA technology starts in the US

WATERLIT : The rapid development of vaccines against COVID-19 led many people to question whether similar investment could have achieved an effective HIV vaccine

PATIENT SATISFACTION WITH TELEHEALTH VISITS FOR NEW PATIENT APPOINTMENTS FOR PELVIC FLOOR DISORDERS: A RANDOMIZED TRIAL OF TELEHEALTH VERSUS STANDARD IN-PERSON OFFICE VISITS

Introduction: Telehealth has emerged as an increasingly useful tool to provide care amidst the COVID-19 pandemic. The acceptability and safety of telehealth has been previously reported in Urogynecology for preoperative counseling and postoperative care but not for new patient evaluation. Objective: To determine if new patient telehealth encounters are non-inferior to inperson office encounters for women presenting to a Urogynecology clinic using a patient satisfaction questionnaire. Secondary objectives were to assess number of follow up visits, phone calls, and travel distance and time. Methods: This was a randomized controlled trial of women presenting to a Urogynecology clinic for a new patient visit. Participants were randomized after appointment scheduling to either telehealth or in-person visits. Telehealth visits were scheduled for 15 minutes and conducted over a video platform by the attending physician. Pelvic exams were not performed over telehealth and patients were counseled and scheduled for follow-up including procedures and treatments. In-person visits included trainees and a pelvic exam. Patients completed the validated Patient Satisfaction Questionnaire-18 (PSQ-18) after their visit. The primary outcome was composite patient satisfaction on the PSQ-18 questionnaire. Demographics and health care utilization data were ed from chart review. Using a non-inferiority margin of 5 points on the PSQ-18 composite score, 25 patients per arm were required with a power of 80% and an alpha of 0.05. Results: From March to September 2021, 133 women were screened for eligibility, 71 were randomized, and 58 were included in the final analysis (30 in telehealth group and 28 in in-person group). Demographic characteristics were similar between groups. Patients overall had a high education level, with 60% having a college degree or higher. Patient satisfaction, as measured on the PSQ-18 questionnaire (maximum score 90), was high for both groups but higher for in-person visits vs telehealth visits (75.68 ± 8.55 vs 66.60 ± 11.80, P = 0.001, difference -9.08, 90% confidence interval -4.57 to -13.6) and our results were inconclusive with respect to determining non-inferiority. Patients ≥60 years reported higher rates of satisfaction overall compared to those younger than 60 years (P = 0.009). Women in the in-person group were more likely to perceive that they had enough time with the provider (P = 0.003) and their visit was timely and efficient (P = 0.016) despite having less attending physician face time. Women in the telehealth group expressed uncertainty regarding the format and the perceived benefits of telehealth. There were no differences in the number of follow up visits (P = 0.81), patient-initiated (P = 0.52) or staff-initiated phone calls (P = 0.07), distance from home to office (P = 0.87), or travel time from home to office (P = 0.94) between groups. There were no differences in treatments (surgical vs non-surgical) chosen based on PSQ-18 scores. Conclusions: Women seen by urogynecologic providers either in person or via telehealth demonstrated high satisfaction with their first visit. Although the results are inconclusive with respect to non-inferiority, telehealth is safe and does not impact conversion to surgical or procedural treatments. As telehealth use continues to demonstrate safety, efficacy, and tolerability by patients, we must educate providers and patients on the utility of this platform.

ASSESSING THE UTILIZATION OF INPATIENT ECONSULTS DURING COVID-19

BACKGROUND: Electronic consultations (eConsults) are formal, asynchronous clinical consultations between primary care providers and specialists. With increasing implementation of inpatient eConsult programs, studies have classified the most frequently consulted departments and reported hospitalist satisfaction, with logistic discussion of inpatient eConsults. However, there are no studies analyzing the time to inpatient eConsult response and the prevalence of COVID-19 in eConsult patients. METHODS: A retrospective chart review of inpatient eConsults at a single U.S. tertiary care medical center from 3/26/20 to 10/8/20. We reviewed patient demographics, COVID-19 status, type of consult question, time to response, conversion rate to a face-to-face visit, and recommendation for outpatient specialty follow-up. RESULTS: There were 538 documented eConsults for 417 patients, with an average age of 52.8 years, 59.0% male, 72.9% white. The most frequently eConsulted departments were Physical Medicine and Rehabilitation (25.7%), Hematology Oncology (13.2%), and Cardiology (7.80%). Inpatient eConsults were predominately regarding patient management questions (87.9%), compared to questions about diagnosis (14.3%) and interpretation of labs or imaging (14.9%). eConsults with multiple question types (15.8%) were more frequent than previously observed in studies of outpatient eConsults. The majority of eConsults were answered and resolved by specialists after one note (61.7%);however, 34.9% of eConsults were followed virtually with multiple notes, and 3.35% were converted to face-to-face consults. Outpatient specialty follow-up was recommended in 12.6% of eConsults. Only 92 (17%) eConsults were linked to orders, enabling measurement of the time the note was signed by the consultant attending physician. The median time from eConsult order until the attending note signature was 14.1 hours. 65.2% of these eConsults had a response within 1 day. 68 study patients (16.3%) were hospitalized with COVID-19, comprising 123 (22.9%) inpatient eConsults. 1.63% of COVID-19 eConsults were converted to face-to-face consultations versus 3.86% of non-COVID-19 eConsults. 72 patients (17.3%) had multiple eConsults, with 39 (9.35%) of these patients having eConsults to multiple different specialties. Of these 39 patients, 21 had COVID-19 during their hospitalization, a higher proportion than the nonCOVID-19 cohort, χ2 (1, N = 417) = 28.083, p < 0.001. CONCLUSIONS: Evaluation of our inpatient eConsult program demonstrates that the majority of eConsults were regarding patient management, with few consults requiring conversion to face-to-face encounters. The findings also reveal an association of multiple specialty eConsults for COVID19 patients. Additionally, inpatient eConsults provide an avenue for reducing consultant exposure to COVID-19. Further efforts can focus on improving the workflow in an effort to optimize consultant response times and assessing the conclusion of outpatient specialty follow-up recommendations.

WOMEN IN THE MIDDLE EAST AND NORTH AFRICA: ISSUES FOR CONGRESS

Many experts have found that women in the Middle East and North Africa (MENA) fare worse than those in other parts of the world on a range of social, economic, legal and political measures. Some attribute this underperformance to prevailing gender roles and perspectives (including discriminatory laws and beliefs), as well as challenges facing the region overall (such as a preponderance of undemocratic governments, poor economic growth, wars, and mass displacement, which often disproportionately affect women). Some key issues facing many women in the region include the following: Unequal Legal Rights. Women in the MENA region face greater legal discrimination than women elsewhere, with differential laws on issues such as marriage, freedom of movement, and inheritance, as well as limited to no legal protection from domestic violence. “h Constraints on Economic Participation and Opportunity. Regional conditions, in addition to gender-based discrimination, contribute to a significant difference between men and women: s participation in MENA economies. For example, women do not participate in the labor force to the same degree as women in other regions, and those who do participate face on average nearly twice the levels of unemployment than men. “h Underrepresentation in Political Processes. Women:X particularly in Yemen, Kuwait and Lebanon:Xare poorly represented in legislative bodies compared to the global average. “h Conflict and Displacement. Women and girls constitute the majority of displaced civilian populations and are at a higher risk of exploitation and abuse in conflict and displacement settings. Experts are particularly concerned about displaced populations in Syria and Yemen. “h Lack of Representation in Conflict Resolution and Peace Negotiations. Women have been sidelined in most formal efforts to resolve the MENAregion: s three largest ongoing wars in Libya, Syria, and Yemen, despite attempts by some international actors to involve women in these processes. “h Susceptibility to Radicalization, Terrorism, and Violent Extremism. Women, like men, are susceptible to radicalization by extremist groups like the Islamic State. Some extremists target women for support and recruitment, though experts have noted that women also may be uniquely positioned to counter violent extremist ideology. In Egypt and Algeria, for example, governments have trained women clerics to counter radicalization. “h Disproportionate Vulnerability to Possible Impacts of the Coronavirus Disease 2019 (COVID-19) Pandemic. Women in the MENA region are experiencing unique and particularly dire effects from the COVID-19 pandemic, though the full effects remain to be seen. Over the years, many Members of Congress have supported U.S. efforts to bolster gender equality in the MENA region in the context of advocating for women: s rights and well-being globally. Some also have argued that supporting women: s rights may advance broader U.S. national security interests in the region. To support these positions, proponents sometimes cite research suggesting that the relative status of women in society appears to be linked to greater political stability, security, and prosperity, as well as to better governance. Congress has addressed issues related to women through foreign assistance appropriations and authorizations, resolutions, statements and letters, and oversight activities. Some of these measures have been global in scope, while others have been region-specific. Going forward, Members may consider whether improvements in the status of women may contribute to other U.S. policy goals, and debate the appropriate level and types of U.S. engagement on the particular challenges facing women in different MENA countries. © 2021 by Nova Science Publishers, Inc.