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

Importance: There is clinical equipoise for COVID-19 convalescent plasma (CCP) use in patients hospitalized with COVID-19. Objective: To determine the safety and efficacy of CCP compared with placebo in hospitalized patients with COVID-19 receiving noninvasive supplemental oxygen. Design, Setting, and Participants: 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. Interventions: A unit of approximately 250 mL of CCP or equivalent volume of placebo (normal saline). Main Outcomes and Measures: 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. Results: 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). Conclusions and Relevance: 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. Trial Registration: ClinicalTrials.gov Identifier: NCT04364737.

Clinical, radiology, pathologic patterns and outcomes of vaping related pulmonary injury in a single institution; A case series.

Since March 2019, E-cigarette or Vaping product associated lung injury (EVALI) has become an ongoing epidemic with more 2600 cases reported in the span of a few months in the United States. EVALI is defined as acute lung injury that develops secondary to the use of e-cigarettes or vaping products within the previous 90 days after exlusion of other possible inciting factors. Vitamin E acetate is believed to play a significant role in its pathogenesis. Treatment involves use of corticosteroids and further avoidance of these products. We describe a case series of 8 patients with EVALI, their clinical course and outcomes. All patients showed an excellent response to corticosteroids. In our experience, prognosis of EVALI is excellent, with complete resolution of symptoms in patients who followed up at 8 weeks.

Anaphylactic reaction to ethylene oxide in a hemodialysis patient.

We present the case of a patient who developed a severe systemic allergic reaction during initiation of hemodialysis. The reaction completely resolved by switching the dialysis filter sterilized by ethylene oxide to a steam sterilized filter. Ethylene oxide is used to sterilize heat sensitive medical devices, and although allergic reactions related to ethylene oxide have been reported before, awareness is lacking among providers in the inpatient setting, specifically in the intensive care unit setting.

Sleep-disordered breathing in heart failure patients after ventricular assist device implantation and heart transplantation.

Chronic heart failure (CHF) represents a major health and economic burden and is associated with high rates of hospital admission, morbidity, mortality and decreased quality-adjusted life years. New advances in the treatment of CHF such as ventricular assist devices (VADs) and heart transplantation have helped improve outcomes. Sleep-disordered breathing (SDB) is highly prevalent in CHF patients and the associated morbidity makes it essential for physicians to be more cognizant about its existence, interaction and need for treatment. This is a review of what is known to date about SDB in CHF patients who have undergone advanced treatments with VADs and/or heart transplantation.

High hypopnea/apnea ratio (HAR) in extreme obesity.

STUDY OBJECTIVES: The study was performed to evaluate the hypothesis that the extremely obese manifest sleep disordered breathing with a preponderance of hypopneas and relative paucity of obstructive apneas. METHODS: Retrospective review of 90 adults with obstructive sleep apnea-hypopnea syndrome (OSAHS) matched for age and gender, comparing two groups, Group A: body mass index (BMI) < 35, Group B: BMI ≥ 45. EXCLUSION CRITERIA: age < 18 years, pregnancy, ≥ 5 central apneas/hour, BMI ≥ 35 < 45. PRIMARY OUTCOME MEASURE: Hypopnea/apnea ratio (HAR); secondary measures: obstructive apnea-hypopnea index (AHI), obstructive and central apnea indices, hypopnea index (HI), oxygen saturation (SpO2) nadir, end-tidal carbon dioxide tension (PetCO2), and presence of obesity-hypoventilation syndrome (OHS). STATISTICAL METHODS: t-test for independent samples; Mann-Whitney, linear regression with natural log transformation, and Kruskal-Wallis χ(2). Descriptive statistics were expressed as interquartile range, median and mean ± standard deviation, p < 0.05 considered significant. RESULTS: Group A (n = 45): age = 50.6 ± 11.5 years, BMI = 28.9 ± 4 kg/m(2); Group B (n = 45): age = 47.4 ± 12.7 years, BMI = 54.5 ± 8 kg/m(2). HAR was significantly higher in Group B (38.8 ± 50.7) than Group A (10.6 ± 16.5), p = 0.0006, as was HI (28.7 ± 28.6 in B vs 12.6 ± 8.4 in A, p = 0.0005) and AHI (35.5 ± 33.8 vs 22 ± 23, p = 0.03), but not apnea index. HAR was significantly higher in Group B regardless of race, gender, or presence of OHS. The BMI was the only significant predictor of HAR (adjusted r(2) = 0.138; p = 0.002) in a linear regression model with natural log transformation of the HAR performed for age, gender, race, BMI, and PetCO2. CONCLUSION: Extremely obese patients manifest OSAHS with a preponderance of hypopneas.