Outpatient Clinical Trial Research Articles

Convalescent Plasma and Other Antibody Therapies for Infectious Diseases-Lessons Learned from COVID-19 and Future Prospects.

Antiviral passive antibody therapy includes convalescent plasma, hyperimmune globulin, and monoclonal antibodies. Passive antibodies have proven effective in reducing morbidity and mortality for SARS-CoV-2 and other infectious diseases when given early in the disease course with sufficiently high specific total and neutralizing antibody levels. Convalescent plasma can be delivered to patients before vaccination implementation or novel drug production. Carefully designed and executed randomized controlled trials near the pandemic outset are important for regulatory bodies, healthcare workers, guideline committees, the public, and the government. Unfortunately, many otherwise well-designed antibody-based clinical trials in COVID-19 were futile, either because they intervened too late in the disease or provided plasma with insufficient antibodies. The need for early treatment mandates outpatient clinical trials in parallel with inpatient trials. Early outpatient COVID-19 convalescent plasma transfusion with high antibody content within 9days of symptom onset has proven effective in blunting disease progression and reducing hospitalization, thus reducing hospital overcrowding in a pandemic. Convalescent plasma offers the opportunity for hope by enabling community participation in outpatient curative therapy while monoclonal therapies, vaccines, and drugs are being developed. Maintaining the appropriate infrastructure for antibody infusion in both outpatient and inpatient facilities is critical for future pandemic readiness.

Comparison of three methodologies for measuring intraocular pressure in healthy cats.

Measuring intraocular pressure (IOP) is crucial for identifying potentially damaging changes in the eyes, including diseases as glaucoma and uveitis. This study compared intraocular pressure (IOP) measurements in cats using the Tonovet and Tonovet Plus (rebound), Tono-Pen Avia Vet (applanation), and Kowa HA-2 (Goldman's methodology applanation) tonometers. 55 healthy cats (108 eyes) were assessed through three distinct studies: An ex vivo experiment (10 eyes of five cats) to correlate IOP manometry and tonometry values and ascertain the correlation coefficient (r2); an in vivo study (10 eyes of five sedated cats) to contrast manometer and tonometer readings; and an outpatient clinical trial (80 eyes of 45 cats) to analyze only tonometer measurements. The r 2 values observed in the ex vivo study were Tonovet (0.923), Tonovet Plus (0.925), Tono-Pen Avia Vet (0.877), and Kowa HA-2 (0.901). The IOP values in mmHg in the in vivo study were as follows: Manometer (16.1 ± 2.7), Tonovet (21.1 ± 3.6), Tonovet Plus (19.7 ± 7.2), Tono-Pen Avia Vet (17.6 ± 7.9), and Kowa HA-2 (16.8 ± 2.0). In the outpatient clinical study, the IOP values in mmHg were as follows: Tonovet (19.7 ± 6.6), Tonovet Plus (17.1 ± 5.4), Tono-Pen Avia Vet (16.3 ± 4.3), and Kowa HA-2 (14.5 ± 2.2). IOP and manometry readings were strongly correlated by all tonometers. In the clinical setting, the most and least IOP measurements were recorded using Tonovet and Kowa HA-2, respectively, stressing the importance of an IOP reference table for each tonometer in feline practice.

Applying human-centered design to adapt the Jumpstart Guide for goals-of-care discussions in persons living with dementia.

Goals-of-care discussions (GOCD) are uncommon in persons living with dementia (PLWD) despite the likelihood of eventual loss of decisional capacity in the population. The Jumpstart Guide, an existing serious illness communication priming tool, can improve GOCD in certain populations, but has not previously been adapted for use among PLWD and their caregivers. Using human-centered design (HCD), we adapted the Jumpstart Guide for use with PLWD and their caregivers. We conducted qualitative interviews with clinicians and caregivers of PLWD. Six team members conducted qualitative rapid analysis of interviews leading to the development of summary templates and integrative matrices. Four iterations of the Jumpstart Guide led to the final version. Thirteen clinicians and 11 caregivers were interviewed. Interviews provided key insights into the unique barriers PLWD and their caregivers face during GOCD, including discomfort with accepting a dementia diagnosis and concern with using "serious illness" to describe dementia, as is commonly done in palliative care. Clinicians described differences in GOCD with PLWD compared to other serious illnesses, and the challenge of getting patients and families to think about future health states. Interviews led to Jumpstart Guide adaptations in the following domains: (1) format and structure, (2) content, and (3) specific language. Suggested changes included prioritizing naming a decision-maker, changing conversation prompts to improve accessibility and understandability, ensuring the Jumpstart Guide could be used with patients as well as their caregivers, and altering language to avoid references to "serious illness" and "abilities." Using HCD yielded valuable insights from clinicians and caregivers about the unique barriers to conducting GOCD among PLWD and their caregivers. These insights were used to adapt the Jumpstart Guide for use with PLWD and their caregivers, which is currently being tested in a pragmatic randomized controlled trial in outpatient clinics.

What to Expect With Pregnant or Postpartum Prescribing of Extended-Release Buprenorphine (CAM2038).

Weekly and monthly CAM2038 (Brixadi®) extended-release subcutaneous buprenorphine (XR bup) has been available in Europe and Australia for several years and was approved by the Food and Drug Administration in May 2023. Little is known about the clinical experience of patients and providers using this new medication during prenatal care. Two cases of pregnant persons with opioid use disorder receiving weekly XR bup in an ongoing randomized multi-site outpatient clinical trial are presented along with a brief review of the pharmacology and literature on XR bup formulations. The cases in pregnancy illustrate how treatment with the weekly formulation is initiated including how to make dose adjustments, which may be necessary given the longer half-life; it takes 1 month to achieve steady state. Injection site pain with medication administration was time limited and managed readily. Other injection site reactions experienced included subcutaneous erythema and induration that was delayed in onset and typically mild, resolving with minimal intervention. Delivery management and breastfeeding recommendations while on weekly XR bup were not different compared to sublingual buprenorphine (SL bup). Weekly XR bup is a new treatment for opioid use disorder that may be used in the obstetric population. Obstetric and addiction medicine clinicians should be aware of this new formulation as its use is expected to increase.

Principle-Guided Psychotherapy for Children and Adolescents (FIRST): study protocol for a randomized controlled effectiveness trial in outpatient clinics

BackgroundHundreds of youth psychotherapy randomized trials have generated scores of helpful empirically supported treatments (ESTs). However, the standardized structure of many ESTs and their focus on a single disorder or homogeneous cluster of problems may not be ideal for clinically referred youths who have comorbidity and whose treatment needs may shift from week to week. This concern has prompted development of flexible transdiagnostic, modular youth psychotherapies. One of these, designed for efficient training and implementation, is FIRST—a transdiagnostic intervention built on five empirically supported principles of change (i.e., feeling calm, increasing motivation, repairing thoughts, solving problems, and trying the opposite) and targeting common internalizing and externalizing youth mental health disorders and problems. FIRST has shown promise in improving youth mental health in three open trials. Now, in a more rigorous test, we seek to (1) conduct a randomized controlled trial comparing FIRST to usual care in real-world clinical practice settings; (2) examine a promising candidate mediator of change—regulation of negative emotions; and (3) explore variables that may influence clinicians’ treatment implementation.MethodsThis is an assessor-naïve randomized controlled effectiveness trial in youth outpatient community clinics in New England and Texas. Using double randomization, clinic-employed clinicians and treatment-referred youths (7–15 years old) are independently randomly allocated (1:1) to FIRST or usual care. We aim to recruit 212 youth participants, all referred through normal community pathways, with elevated symptoms of anxiety, depression, conduct problems, or post-traumatic stress. This study will test the effectiveness of FIRST compared to usual care on mental health outcomes, examine whether those outcomes are mediated by regulation of negative emotions, and explore clinician factors that may be associated with FIRST implementation and outcomes. Session recordings are coded to assess treatment fidelity.DiscussionThis study will evaluate the effectiveness of FIRST in youth community mental health settings, relative to the care usually provided in those settings. If FIRST is found to be effective, it could offer an efficient and practical method to increase use of empirically supported treatment principles in real-world practice contexts.Trial registrationNIH Clinical Trials Registry, NCT04725721. Registered 27 January 2021, https://clinicaltrials.gov/ct2/show/study/NCT04725721

Open label trial of lofexidine-assisted non-opioid induction onto naltrexone extended-release injection for opioid use disorder

ABSTRACT Background: Opioid use disorder (OUD) continues to be major public health problem in the US and innovative medication strategies are needed. The extended-release injectable formulation of naltrexone (ER-NTX), an opioid receptor antagonist, is an effective treatment for OUD, but the need for an opioid-free period during the induction phase of treatment is a barrier to treatment success, particularly in the outpatient setting. Lofexidine, an alpha-2-adrenergic agonist, is an effective treatment for opioid withdrawal. Objectives: To evaluate the feasibility, safety, and tolerability of lofexidine for facilitating induction onto ER-NTX in the management of OUD. Methods: In an open-label, uncontrolled, 10-week outpatient clinical trial, 20 adults (four women) with OUD were treated with a fixed-flexible dosing strategy (maximum 0.54 mg 4×/daily) of lofexidine for up to 10 days to manage opioid withdrawal prior to receiving ER-NTX. The COVID-19 pandemic resulted in a modification of the study methods after enrolling 10 participants who attended all visits in person. The second group of 10 participants attended most induction period visits remotely. Results: Overall, 10 of the 20 participants (50%) achieved the primary outcome by receiving the first ER-NTX injection. Rates of induction success did not differ by the presence of fentanyl or remote visit attendance, although the small sample size provided limited statistical power. Six out of 20 participants (30%) initiated on lofexidine required dose adjustments. There were no study-related serious adverse events. Conclusions: This study provides preliminary evidence supporting the feasibility of inducting individuals with OUD onto ER-NTX using lofexidine.

Development and validation of a product acceptability questionnaire for intranasal Q-Griffithsin COVID-19 prophylaxis (SPRAY PAL)

ObjectivesPatient experiences are critical when determining the acceptability of novel interventional pharmaceuticals. Here, we report the development and validation of a product acceptability questionnaire (SPRAY PAL) assessing feasibility, acceptability and...

Transfusion reactions associated with COVID-19 convalescent plasma in outpatient clinical trials.

COVID-19 convalescent plasma (CCP) is an important therapeutic option for outpatients at high risk of hospitalization from SARS-CoV-2 infection. We assessed the safety of outpatient CCP transfusions administered during clinical trials. We analyzed data pertaining to transfusion-related reactions from two randomized controlled trials in the U.S. that evaluated the efficacy of CCP versus control plasma in various ambulatory settings. Multivariable logistic regression was used to assess whether CCP was associated with transfusion reactions, after adjusting for potential confounders. The combined study reported 79/1351 (5.9%) adverse events during the transfusion visit, with the majority 62/1351 (4.6%) characterized by mild, allergic-type findings of urticaria, and/or pruritus consistent with minor allergic transfusion reactions; the other reported events were attributed to the patients' underlying disease, COVID-19, or vasovagal in nature. We found no difference in the likelihood of allergic transfusion reactions between those receiving CCP versus control plasma (adjusted odds ratio [AOR], 0.75; 95% CI, 0.43-1.31). Risk of urticaria and/or pruritus increased with a pre-existing diagnosis of asthma (AOR, 2.33; 95% CI, 1.16-4.67). We did not observe any CCP-attributed antibody disease enhancement in participants with COVID-19 or increased risk of infection. There were no life-threatening severe transfusion reactions and no patients required hospitalization related to transfusion-associated complications. Outpatient plasma administration was safely performed for nearly 1400 participants. CCP is a safe therapeutic option for outpatients at risk of hospitalization from COVID-19.

Implementation of a Patient Acuity Tool and Safe Staffing Model in an Outpatient Oncology Clinical Trials Unit.

Appropriate staffing in the outpatient oncology setting contributes to the delivery of quality care. Objective measures of acuity and nursing workload can assist with developing staffing models; however, measuring acuity in a.

Stakeholder-driven development and implementation of CRICIT: an app to support high-quality data capture and protocol monitoring for outpatient clinical trials with vulnerable populations.

Choosing an appropriate electronic data capture system (EDC) is a critical decision for all randomized controlled trials (RCT). In this paper, we document our process for developing and implementing an EDC for a multisite RCT evaluating the efficacy and implementation of an enhanced primary care model for individuals with opioid use disorder who are returning to the community from incarceration. Informed by the Knowledge-to-Action conceptual framework and user-centered design principles, we used Claris Filemaker software to design and implement CRICIT, a novel EDC that could meet the varied needs of the many stakeholders involved in our study. CRICIT was deployed in May 2021 and has been continuously iterated and adapted since. CRICIT's features include extensive participant tracking capabilities, site-specific adaptability, integrated randomization protocols, and the ability to generate both site-specific and study-wide summary reports. CRICIT is highly customizable, adaptable, and secure. Its implementation has enhanced the quality of the study's data, increased fidelity to a complicated research protocol, and reduced research staff's administrative burden. CRICIT and similar systems have the potential to streamline research activities and contribute to the efficient collection and utilization of clinical research data.

Implementing an outpatient clinical trial on COVID-19 treatment in an emergency epidemic context: a mixed methods study among operational and research stakeholders within the Coverage trial, Bordeaux (France)

BackgroundThe emergency set-up and implementation of outpatient clinical trials on epidemic emerging infectious diseases such as COVID-19 raise many issues in terms of research structuration, regulations, and health systems organization. We aimed to describe the experience and points of view of different stakeholders involved in a French home-based outpatient trial on COVID-19 and to identify the early barriers and facilitators to the trial implementation.MethodsWe conducted a mixed-methods study in July 2020. A self-administered questionnaire was emailed to 213 clinical, operational and research stakeholders involved in the Coverage trial; individual semi-directed interviews were conducted among 14 stakeholders. Questionnaire data and written interview notes are presented together by key theme.ResultsOne hundred fifty six stakeholders responded to the questionnaire. 53.4% did not have prior experience in clinical research. The motivation of most stakeholders to participate in the Coverage trial was to feel useful during the pandemic. 87.9% agreed that the trial had an unusual set-up timeframe, and many regretted a certain lack of regulatory flexibility. Mobile medical teams and specific professional skills were perceived as instrumental for outpatient research.ConclusionsThe implementation of a home-based outpatient clinical trial on COVID-19 was perceived as relevant and innovative although requiring important adaptations of usual professional responsibilities and standard research procedures. Lessons learned from the Coverage trial underline the need for improved networks between hospital and community medicine, and call for a dedicated and reactive outpatient research platform on emerging or threatening infectious diseases.

Successful recruitment of monolingual Spanish speaking Latinos to university phase II and III outpatient COVID-19 clinical treatment trials in Northern California

Through a public County/University partnership, we employed a Spanish/English bilingual research coordinator to increase awareness of newly available treatments with FDA Emergency Use Authorization and clinical trial opportunities for Latino outpatients with mild to moderate COVID-19. Out of the 550 San Mateo County outpatients with COVID-19 referred to Stanford University between July 2020 and April 2022, 9.5% elected to receive monoclonal antibody EUA treatment. COVID-19 treatment trial enrollment of County patients, 5% of those recruited, was commensurate with non-County populations enrollment. Recruitment models such as ours have the potential to increase US Latino populations' recruitment in outpatient COVID-19 treatment trials and contribute to decreasing COVID-19 health disparities.

PCR93 Comprehensibility and Usability of an Electronic COVID-19 Daily Symptom Diary

Symptoms of COVID-19 are heterogeneous across individuals and can range from mild to severe. Labcorp Drug Development (LDD) created an electronic COVID-19 Daily Symptom Diary, in accordance with FDA guidance, to assess frequency and severity of COVID-19 symptoms in adult individuals with mild to moderate disease severity for use as an endpoint measure in outpatient clinical trials of treatments for COVID-19. This study evaluated how participants who have previously contracted COVID-19 completed, understood, and interacted with the electronic COVID-19 Daily Symptom Diary.

1359-P: Effect of Fat Content on Postprandial Gastric Retention and Glucose Absorption in Subjects with Type 1 Diabetes during Daily Life Conditions: Assessment through a Computational Model

Understanding the impact of dietary nutrients on postprandial gastric retention (GR) and glucose absorption (GA) is crucial for optimizing both open- and closed-loop therapy in type 1 diabetes (T1D) . Here, we aim to investigate the effect of fat (F) content of a meal on both GR and GA in real life conditions, using a recently developed minimally invasive oral minimal model (MI-OMM) . Data was collected during an outpatient 5-days clinical trial involving 1patients (age = 3-61 y; M/F = 60/50) wearing a sensor augmented insulin pump. At each meal, the medical staff recorded carbohydrate (C) and F intake. A total of 159 meals were analyzed that included >75% sensor data, C and F contents, no exercise sessions, or other meals/snacks within 2h before and 3h after the meal. Meals were grouped based on F content: high fat (HF, F≥30%) , and Low Fat (LF, F≤15%) . The model well fitted glucose sensor data and provided estimated GR and GA curves. Fig. 1 shows that model-derived GR was significantly lower from 0.5h onward, and GA was significantly faster from 0.5h to 2.3h after a LF meal compared to a HF. These findings proved that MI-OMM can be used to estimate GR and GA, using sensor data, in real life meals with different F content and, therefore, it is potentially applicable to optimize insulin therapy in T1D. Disclosure E.Faggionato: None. M.Schiavon: None. B.A.Buckingham: Advisory Panel; Arecor, Lilly Diabetes, Medtronic, Other Relationship; Insulet Corporation, Research Support; Insulet Corporation, Lilly Diabetes, Medtronic. L.Ekhlaspour: Consultant; Tandem Diabetes Care, Inc., Ypsomed AG. C.Dalla man: Research Support; Becton, Dickinson and Company, Sanofi-Aventis Deutschland GmbH. Funding This work was supported by MIUR (Italian Minister for Education) under the initiative “Departments of Excellence” (Law 232/2016) . Laya Ekhlaspour is funded by NIH (National Institutes of Health) 1K23DK121942.

The effect of different service models on quality of care in the assessment of autism spectrum disorder in children: study protocol for a multi-centre randomised controlled trial

BackgroundThere is significant variability in clinical pathways available in the diagnostic assessment of ASD, including the order and timing of allied health assessments in relation to paediatrician consultations. Allied health professionals in first-contact models are increasingly used to improve the timeliness of healthcare access, whilst complementing medical specialty workforce shortages. Anecdotally, the implementation of allied health first-contact models in paediatrics has improved waitlists and timely access to healthcare. However, no rigorous studies have been conducted to evaluate the outcomes of these models. This study aims to determine the impacts of an allied health first-contact model on health service use and costs and patient quality of life and satisfaction.MethodsAn open, semi-blinded, multi-centre randomised controlled trial in paediatric outpatient clinics at two Australian metropolitan public hospitals. 56 children (0–16 years) fulfilling the inclusion criteria will be randomised to one of two clinical pathways for assessment of ASD: (1) allied health first-contact or (2) medical first-contact model. Cost outcomes will be collected from both health service and family perspectives. Caregiver-reported outcome measures include: Pediatric Quality of Life Inventory (PedsQL), the EuroQOL Five Dimension Youth Version (EQ-5D-Y), the Autism Family Experience Questionnaire (AFEQ) and Measure of Processes of Care.DiscussionEvidence of improvements in service and consumer centric outcomes will help inform the development and implementation of high-value, evidenced based models of care for the assessment of ASD in children. The findings from this study are expected to contribute to the evidence base around the costs and consequences of allied health first contact models for the assessment of children with ASD in the Australian setting. Findings of this study may help to inform the allocation of health care resources while maintaining, or potentially improving, patient and family quality of life and experience of care. These findings may be useful in informing the wider adoption of these models in Australia and internationally, particularly in healthcare settings where medical specialist shortages exist.Trial registrationAustralia and New Zealand Clinical Trials Register (ANZCTR) ACTRN12621001433897. Registered: 25th October, 2021.

Efficacy and safety of a universal influenza A vaccine (MVA-NP+M1) in adults when given after seasonal quadrivalent influenza vaccine immunisation (FLU009): a phase 2b, randomised, double-blind trial

In animal, epidemiological, and human challenge studies, a pre-existing T-cell response to internal proteins of influenza A has been associated with improved virological and disease outcomes. The aim of this study was to assess whether inducing additional responses to conserved CD4 and CD8 T-cell antigens provides added benefit to standard influenza vaccination. We designed a phase 2b, randomised, placebo-controlled, double-blind trial of a recombinant viral-vectored vaccine (modified vaccinia Ankara expressing virus nucleoprotein and matrix protein 1; MVA-NP+M1), which has been shown to induce both CD4 and CD8 T cells, at eight outpatient clinical trial sites in Australia over two consecutive influenza seasons. We recruited non-immunosuppressed adults (≥18 years) who had received the 2019 quadrivalent influenza vaccine (QIV) vaccine within 28 days before study enrolment and randomisation (day 0). Participants were randomly assigned (1:1) according to a computer-generated random sequence to receive one dose of 1·5 × 108 plaque-forming units of MVA-NP+M1 or saline (placebo) intramuscularly. Randomisation was stratified by age (<65 years or ≥65 years). The patients and trial assessors were masked to treatment assignment. During the subsequent influenza seasons, participants with symptoms related to respiratory illness or influenza-like illness were to attend the clinic within 72 h of symptom onset for two nasal swabs for influenza testing by quantitative RT-PCR. The primary endpoint was the incidence rate of laboratory-confirmed influenza in the intention-to-treat (ITT) population. Safety (solicited adverse events within 7 days and unsolicited adverse events within 28 days after study vaccination, and serious adverse events for the study duration) was assessed in all randomly assigned participants who received at least one vaccination (according to the treatment received). The trial is registered with ClinicalTrials.gov, NCT03880474. Between April 2 and June 14, 2019, 2152 adults were randomly allocated and received MVA-NP+M1 (n=1077) or placebo (n=1075), comprising the efficacy (ITT) analysis set. Participants were followed up throughout the 2019 Australia influenza season (May 1 to Oct 15, 2019). 419 (19·5%) of 2152 participants were aged 65 years or older. The incidence of laboratory-confirmed influenza did not differ between the MVA-NP+M1 group (35 of 1077 participants; 3·25% [95% CI 2·31-4·44]) and the placebo group (23 of 1075; 2·14% [1·39-3·14]; Fisher's exact p=0·14). 23 severe solicited local injection site reactions were reported in 13 (0·6%) of 2152 participants, 22 of which were reported in the MVA-NP + M1 group (in 12 [1·1%] participants). 100 severe systemic events were reported in 45 (4·2%) MVA-NP + M1 recipients, and 20 were reported in 14 (1·3%) placebo recipients. Three unsolicited grade 3 events in three participants (two headache and one nausea, all in the MVA-NP+M1 group) were deemed vaccine related. 21 serious adverse events were reported in 18 (1·7%) of 1077 participants in the MVA-NP+M1 group and 25 serious adverse events were reported in 22 (2·0%) of 1075 participants in the placebo group; none were considered vaccine related. The trial was stopped after one season for futility on the recommendation of the data monitoring committee. MVA-NP+M1 was well tolerated with no vaccine-associated serious adverse events. A vaccine designed to induce moderate T-cell responses to the cross-reactive internal proteins of influenza A did not lead to improved incidence when given within 28 days after standard QIV immunisation. A greater magnitude of T-cell response with a different vaccine or regimen, or localisation in the lungs via alternative delivery, such as intranasal or aerosol, might be successful and require further investigation. Vaccitech.

Outpatient healthcare and clinical trials in the care pathway: Organisational and regulatory aspects and tools

Clinical research in outpatient healthcare, particularly in general practice, which is the first line of contact with the population, is now a public health issue. However, this type of research has specific characteristics that differentiate it from clinical research conducted in a hospital setting and requires an adaptation of its conditions of practice: in terms of organisation, the development of research in outpatient healthcare relies on the appropriation of its fundamentals by the investigators, which implies their presentation, upstream, from the initial cycle, and the participation of practitioners in training modules adapted to research in primary care, such as those already organised by several GIRCI (Groupement Inter régional de la Recherche Clinique et de l'Innovation [French Interregional Clusters for Clinical Research and Innovation]). To compensate for the fragmented nature of their location, on the model of the EMRCs (équipes mobiles de recherche clinique [mobile clinical research teams]) in oncology, mobile research teams should enable general medical practices to participate in clinical trials. This presupposes, on the one hand, the allocation of earmarked funding to ensure the sustainability of a base of dedicated personnel and, on the other hand, the impetus of a national dynamic through the setting up of a multi-organisation thematic institute for "research in primary care" associated, at the operational level, with a national scale investigation network supported by a platform of excellence. The use of digital tools and innovations (telemedicine; data collection via connected tools; e-consent; electronic signature) which make it possible to digitise and relocate all or part of the research procedures for both the participant and the investigation teams. An adaptation of the legal framework in order to bring the place of research closer to the patient and not the other way round, which means moving the equipment and investigations closer to the patient. Taking into account the acceptability of the patient, thus limiting the disruption that may be caused by his or her participation in a research protocol and motivating the practitioner by valuing his or her contribution and providing all the guarantees of scientific relevance and independence of practice. In view of the contextual analysis, positive feedback and the availability of organisational and digital support points facilitating the delocalisation and digitisation of the conduct of research activity as close as possible to the patient and his or her doctor, the round table concluded that opportunities exist today which favour the development of clinical research in general practice. It is important to seize this opportunity and make the most of it without delay.

Intranasal oxytocin may improve odds of abstinence in cocaine-dependent patients: results from a preliminary study

BackgroundOxytocin (OT) treatment in drug addiction studies have suggested potential therapeutic benefits. There is a paucity of clinical trial studies of oxytocin in cocaine use disorders. MethodThis was a 6-week randomized, double-blind, outpatient clinical trial study investigating the effect of daily Intranasal Oxytocin (24 IU) on cocaine use by cocaine use disorder patients. After a 7-day inpatient abstinence induction stage, patients were randomized to intranasal oxytocin or intranasal placebo. During the outpatient phase, cocaine use disorder patients were required to present themselves to the research staff 3 times a week for witnessed randomized medication administration, to provide a urine sample for qualitative toxicology, and complete mandatory assessments, including the Time-Line-Follow Back. For the interim days, patients were given an “at-home” bottle that was weighed at each clinic visit to monitor compliance. ResultsNeither administration of Intranasal placebo (n = 11) or Oxytocin (n = 15) induced at least 3 weeks of continuous abstinence. However, from week 3, the odds of weekly abstinence increased from 4.61 (95% CI = 1.05, 20.3) to 15.0 (CI = 1.18, 190.2) by week 6 for the Intranasal Oxytocin group (t = 2.12, p = 0.037), though there was no significant group difference overall in the odds of abstinence over time (F1,69 = 1.73, p = 0.19). More patients on Intranasal Oxytocin dropped out (p = 0.0005). ConclusionsIntranasal Oxytocin increased the odds of weekly abstinence in Cocaine patients after 2 weeks compared to PBO, but was associated with a higher dropout rate. (ClinicalTrials.gov 02,255,357, 10/2014)

1330. Clinical Associations and Trajectory of “Long COVID”

BackgroundPersistent symptoms after acute COVID-19 are being increasingly reported. To date, little is known about the cause, clinical associations, and trajectory of “Long COVID”.MethodsParticipants of an outpatient clinical trial of Peginterferon-Lambda as treatment for uncomplicated SARS-CoV-2 infection were invited to long term follow-up visits 4, 7, and 10 months after initial COVID-19 diagnosis. Ongoing symptoms and functional impairment measures (work productivity and activity index (WPAI), NIH toolbox smell test, 6-minute walk test) were assessed and blood samples obtained. “Long COVID” was defined as presence of 2 or more typical symptoms (fatigue, hyposmia/hypogeusia, dyspnea, cough, palpitations, memory problems, joint pain) at follow up. Associations between baseline characteristics, initial COVID-19 clinical course, and presence of “Long COVID” during follow-up were assessed using generalized estimating equations accounting for repeated measurements within individuals.ResultsEighty-seven participants returned for at least one follow-up visit. At four months, 29 (34.1%) had “Long COVID”; 19 (24.7%) met criteria at 7 months and 18 (23.4%) at 10 months (Figure 1). Presence of “Long COVID” symptoms did not correlate significantly with functional impairment measures. Female gender (OR 3.01, 95% CI 1.37-6.61) and having gastrointestinal symptoms during acute COVID-19 illness (OR 5.37, 95% CI 1.02-28.18) were associated with “Long COVID” during follow-up (Figure 2). No significant associations with baseline immunologic signatures were observed. Figure 1. Alluvial plot of long term follow-up participants showing outcomes of symptoms at each visit. Figure 2. Generalized Estimating Equations Model showing associations with “Long COVID” (presence of 2+ symptoms) at month 4, 7, and 10 following acute infection using unstructured correlation matrix.Conclusion“Long COVID” was prevalent in this outpatient trial cohort and had low rates of resolution over 10 months of follow up. Female sex and gastrointestinal symptoms during acute illness were associated with “Long COVID”. Identifying modifiable risk factors associated with the development of persistent symptoms following SARS-CoV-2 infection remains a critical need.Disclosures All Authors: No reported disclosures

Open-label trial of a single-day induction onto buprenorphine extended-release injection for users of heroin and fentanyl.

Fentanyl and other highly potent synthetic opioidsare the leading cause of opioid overdose deaths in the United States. This study wasan open-label, uncontrolled 12-week outpatient clinical trial to test the feasibility of a single-day induction onto extended-release buprenorphine (BXR) injection treatment for five adults (N = 5) with opioid use disorder using heroin-containing fentanyl. Participants were planned to receive three monthly BXR injections (300, 300, and 100 mg). After receiving 24 mg sublingual buprenorphine (SL-BUP), all five participants received the BXR 300 mg injection on the first day of induction. All five participants were retained for the full 3-month study period postinduction and received all three scheduled BXR injections. This study provides preliminary evidence supporting the feasibility of inducting users of heroin-containing fentanyl onto BXR 300 mg in a single day. The ability to administer a long-acting injection of BXR that assures therapeutic serum levels for a month on the first day of treatment contact is a promising development for the treatment of OUD.