4142 Implementation of Consent-to-Contact (CTC) initiative at an Academic Medical center: Initial operationalization and lessons learned

OBJECTIVES/GOALS: The objectives of this presentation are to discuss 1) the implementation of Consent to Contact at an Academic Medical Center; 2) the access to lists of potential participants by study teams; and 3) the challenges and adjustments made to the initial conceptualized process. METHODS/STUDY POPULATION: Participant recruitment is critical to the success of all research studies. It is particularly challenging when investigators do not have a patient population from which to recruit. Thus, the University of Miami launched the CTC initiative in 2016 to facilitate study recruitment. Study investigators can request access to a registry of participants who agreed to be contacted and meet the initial study eligibility criteria. A multidisciplinary Operational Committee provides oversight and regulates access to the CTC registry. RESULTS/ANTICIPATED RESULTS: The registry has over 110K patients who have agreed to be contacted for eligible research studies. The demographic distribution of the patients in the registry mirrors the diversity of the UHealth population. As of January 2018, when the registry became available to the research community, 25 study teams from different departments, including the All of Us Research Program, have requested potential participant lists. The process of requesting access to patient lists is adapted to studies’ needs, with particular reference to sensitive populations, such as HIV/AIDS, substance abuse, etc. Results on utilization and satisfaction of the CTC initiative are being collected and will be presented. DISCUSSION/SIGNIFICANCE OF IMPACT: The CTC initiative allows UHealth patients to opt-in to the registry for research studies. The Operational Committee continues to monitor the successful consent of patients to participate in individual research studies and improving the request process

COVID-19 Convalescent Plasma Therapy: Long Term Implications

Abstract Background The long-term effect of Coronavirus Disease 2019 (COVID-19) acute treatments on post-acute sequelae of SARS-CoV-2 infection (PASC) is unknown. The CONTAIN-Extend study explores the long-term impact of COVID-19 convalescent plasma (CCP) therapy on Post-Acute Sequelae of SARS-CoV-2 infection (PASC) symptoms and general health 18 months following hospitalization. Methods The CONTAIN-Extend study examined 281 participants from the original CONTAIN COVID-19 trial (CONTAIN-RCT, NCT04364737) at 18 months post-hospitalization for acute COVID-19. Symptom surveys, global health assessments, and biospecimen collection was performed from November 2021 to October 2022. Multivariable logistic and linear regression estimated associations between the randomization arms and self-reported symptoms and PROMIS scores, adjusted for covariables, including age, sex, race/ethnicity, disease severity, and CONTAIN enrollment quarter and sites. Results There were no differences in symptoms or PROMIS scores between CCP and placebo (adjusted odds ratio of general symptoms, 0.95; 95% confidence intervals, 0.54, 1.67). However, females (3.01; 1.73, 5.34), those 45-64 years (2.55; 1.14, 6.23), and April-June 2020 enrollees (2.39; 1.10, 5.19) were more likely to report general symptoms and have poorer PROMIS physical health scores than their respective reference groups. Hispanic participants (difference, -3.05; 95% CI, -5.82, -0.27) and Black participants (-4.48; -7.94, -1.02) had poorer PROMIS physical health than White participants. Conclusions CCP demonstrated no lasting effect on PASC symptoms or overall health in comparison to the placebo. This study underscores the significance of demographic factors, including sex, age, and the timing of acute infection, in influencing symptom reporting 18 months after acute hypoxic COVID-19 hospitalization

Efficacy and Safety of COVID-19 Convalescent Plasma in Hospitalized Patients: A Randomized Clinical Trial

There is clinical equipoise for COVID-19 convalescent plasma (CCP) use in patients hospitalized with COVID-19. To determine the safety and efficacy of CCP compared with placebo in hospitalized patients with COVID-19 receiving noninvasive supplemental oxygen. CONTAIN COVID-19, a randomized, double-blind, placebo-controlled trial of CCP in hospitalized adults with COVID-19, was conducted at 21 US hospitals from April 17, 2020, to March 15, 2021. The trial enrolled 941 participants who were hospitalized for 3 or less days or presented 7 or less days after symptom onset and required noninvasive oxygen supplementation. A unit of approximately 250 mL of CCP or equivalent volume of placebo (normal saline). The primary outcome was participant scores on the 11-point World Health Organization (WHO) Ordinal Scale for Clinical Improvement on day 14 after randomization; the secondary outcome was WHO scores determined on day 28. Subgroups were analyzed with respect to age, baseline WHO score, concomitant medications, symptom duration, CCP SARS-CoV-2 titer, baseline SARS-CoV-2 serostatus, and enrollment quarter. Outcomes were analyzed using a bayesian proportional cumulative odds model. Efficacy of CCP was defined as a cumulative adjusted odds ratio (cOR) less than 1 and a clinically meaningful effect as cOR less than 0.8. Of 941 participants randomized (473 to placebo and 468 to CCP), 556 were men (59.1%); median age was 63 years (IQR, 52-73); 373 (39.6%) were Hispanic and 132 (14.0%) were non-Hispanic Black. The cOR for the primary outcome adjusted for site, baseline risk, WHO score, age, sex, and symptom duration was 0.94 (95% credible interval [CrI], 0.75-1.18) with posterior probability (P[cOR<1] = 72%); the cOR for the secondary adjusted outcome was 0.92 (95% CrI, 0.74-1.16; P[cOR<1] = 76%). Exploratory subgroup analyses suggested heterogeneity of treatment effect: at day 28, cORs were 0.72 (95% CrI, 0.46-1.13; P[cOR<1] = 93%) for participants enrolled in April-June 2020 and 0.65 (95% CrI, 0.41 to 1.02; P[cOR<1] = 97%) for those not receiving remdesivir and not receiving corticosteroids at randomization. Median CCP SARS-CoV-2 neutralizing titer used in April to June 2020 was 1:175 (IQR, 76-379). Any adverse events (excluding transfusion reactions) were reported for 39 (8.2%) placebo recipients and 44 (9.4%) CCP recipients (P = .57). Transfusion reactions occurred in 2 (0.4) placebo recipients and 8 (1.7) CCP recipients (P = .06). In this trial, CCP did not meet the prespecified primary and secondary outcomes for CCP efficacy. However, high-titer CCP may have benefited participants early in the pandemic when remdesivir and corticosteroids were not in use. ClinicalTrials.gov Identifier: NCT04364737