Practical application of good participatory practices for trials of emerging pathogens: Developing materials for use in ACTIV-3, -3b, and ACTIV-associated COVID-19 trials.

The emergence of the COVID-19 pandemic required an immediate global clinical research response. The ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines)-3 trials and the ACTIV-associated Outpatient Treatment with Anti-Coronavirus Immunoglobulin trial used Good Participatory Practices (GPP) to develop materials for study implementation from a global network perspective. GPP guidelines offer a framework for engaging stakeholders throughout the research process.

Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19 : A Randomized Controlled Trial.

Background: Ensovibep (MP0420) is a designed ankyrin repeat protein, a novel class of engineered proteins, under investigation as a treatment of SARS-CoV-2 infection.

Objective: To investigate if ensovibep, in addition to remdesivir and other standard care, improves clinical outcomes among patients hospitalized with COVID-19 compared with standard care alone.

Design: Double-blind, randomized, placebo-controlled, clinical trial.

Multidimensional aspects of dyspnea in obese patients referred for cardiopulmonary exercise testing.

We investigated the contributions of obesity on multidimensional aspects of dyspnea on exertion (DOE) in patients referred for clinical cardiopulmonary exercise testing (CPET). Ratings of perceived breathlessness (RPB, Borg scale 0-10) were collected in obese (BMI ≥ 30; n = 47) and nonobese (BMI ≤ 25; n = 27) patients during two (one lower: ∼30 W; and one higher: ∼50 W) 4-6 min constant load cycling bouts. Multidimensional dyspnea profiles (MDP) were collected in the final 26 obese and 14 nonobese patients of the sample.

Weight loss reduces dyspnea on exertion and unpleasantness of dyspnea in obese men.

We hypothesized that weight loss would ameliorate dyspnea on exertion (DOE) and feelings of unpleasantness related to the DOE in obese men. Eighteen men (34 ± 7yr, 35 ± 4 kg/m BMI, mean ± SD) participated in a 12-week weight loss program. Body composition, pulmonary function, cardiorespiratory measures, DOE, and unpleasantness (visual analog scale) were assessed before and after weight loss.

Dyspnea on exertion provokes unpleasantness and negative emotions in women with obesity.

Purpose: While dyspnea on exertion (DOE) is a common complaint in otherwise healthy obese women, less is known about feelings of unpleasantness and/or negative emotions provoked by DOE. We examined whether ratings of perceived breathlessness (RPB) during exercise were associated with ratings of unpleasantness and negative emotions (depression, anxiety, frustration, anger, and fear) in obese women.

Methods: Seventy-four women (34 ± 7 yrs, 36 ± 4 kg/m, 46 ± 5% body fat) performed 6 min of constant-load cycling (60 W); RPB (0-10 scale), and unpleasantness and negative emotions (visual analog scales, 10 cm) were assessed at the end.