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1.
The American journal of emergency medicine ; 2023.
Article in English | EuropePMC | ID: covidwho-2280208

ABSTRACT

Study objective During the COVID-19 pandemic, prescribing supplemental oxygen was a common reason for hospitalization of patients. We evaluated outcomes of COVID-19 patients discharged from the Emergency Department (ED) with home oxygen as part of a program to decrease hospital admissions. Methods We retrospectively observed COVID-19 patients with an ED visit resulting in direct discharge or observation from April 2020 to January 2022 at 14 hospitals in a single healthcare system. The cohort included those discharged with new oxygen supplementation, a pulse oximeter, and return instructions. Our primary outcome was subsequent hospitalization or death outside the hospital within 30 days of ED or observation discharge. Results Among 28,960 patients visiting the ED for COVID-19, providers admitted 11,508 (39.7%) to the hospital, placed 907 (3.1%) in observation status, and discharged 16,545 (57.1%) to home. A total of 614 COVID-19 patients (535 discharge to home and 97 observation unit) went home on new oxygen therapy. We observed the primary outcome in 151 (24.6%, CI 21.3–28.1%) patients. There were 148 (24.1%) patients subsequently hospitalized and 3 (0.5%) patients who died outside the hospital. The subsequent hospitalized mortality rate was 29.7% with 44 of the 148 patients admitted to the hospital dying. Mortality all cause at 30 days in the entire cohort was 7.7%. Conclusions Most patients discharged to home with new oxygen for COVID-19 safely avoid later hospitalization and few patients die within 30 days. This suggests the feasibility of the approach and offers support for ongoing research and implementation efforts.

2.
Clin Infect Dis ; 76(12): 2077-2086, 2023 Jun 16.
Article in English | MEDLINE | ID: covidwho-2268565

ABSTRACT

BACKGROUND: Outpatient monoclonal antibodies are no longer effective and antiviral treatments for coronavirus disease 2019 (COVID-19) disease remain largely unavailable in many countries worldwide. Although treatment with COVID-19 convalescent plasma (CCP) is promising, clinical trials among outpatients have shown mixed results. METHODS: We conducted an individual participant data meta-analysis from outpatient trials to assess the overall risk reduction for all-cause hospitalizations by day 28 in transfused participants. Relevant trials were identified by searching Medline, Embase, medRxiv, World Health Organization COVID-19 Research Database, Cochrane Library, and Web of Science from January 2020 to September 2022. RESULTS: Five included studies from 4 countries enrolled and transfused 2620 adult patients. Comorbidities were present in 1795 (69%). The virus neutralizing antibody dilutional titer levels ranged from 8 to 14 580 in diverse assays. One hundred sixty of 1315 (12.2%) control patients were hospitalized, versus 111 of 1305 (8.5%) CCP-treated patients, yielding a 3.7% (95% confidence interval [CI], 1.3%-6.0%; P = .001) absolute risk reduction and 30.1% relative risk reduction for all-cause hospitalization. The hospitalization reduction was greatest in those with both early transfusion and high titer with a 7.6% absolute risk reduction (95% CI, 4.0%-11.1%; P = .0001) accompanied by at 51.4% relative risk reduction. No significant reduction in hospitalization was seen with treatment >5 days after symptom onset or in those receiving CCP with antibody titers below the median titer. CONCLUSIONS: Among outpatients with COVID-19, treatment with CCP reduced the rate of all-cause hospitalization and may be most effective when given within 5 days of symptom onset and when antibody titer is higher.


Subject(s)
COVID-19 , Adult , Humans , COVID-19/therapy , Outpatients , SARS-CoV-2 , COVID-19 Serotherapy , Randomized Controlled Trials as Topic , Hospitalization
3.
JCI Insight ; 8(8)2023 04 24.
Article in English | MEDLINE | ID: covidwho-2271561

ABSTRACT

Multiple randomized, controlled clinical trials have yielded discordant results regarding the efficacy of convalescent plasma in outpatients, with some showing an approximately 2-fold reduction in risk and others showing no effect. We quantified binding and neutralizing antibody levels in 492 of the 511 participants from the Clinical Trial of COVID-19 Convalescent Plasma in Outpatients (C3PO) of a single unit of COVID-19 convalescent plasma (CCP) versus saline infusion. In a subset of 70 participants, peripheral blood mononuclear cells were obtained to define the evolution of B and T cell responses through day 30. Binding and neutralizing antibody responses were approximately 2-fold higher 1 hour after infusion in recipients of CCP compared with saline plus multivitamin, but levels achieved by the native immune system by day 15 were almost 10-fold higher than those seen immediately after CCP administration. Infusion of CCP did not block generation of the host antibody response or skew B or T cell phenotype or maturation. Activated CD4+ and CD8+ T cells were associated with more severe disease outcome. These data show that CCP leads to a measurable boost in anti-SARS-CoV-2 antibodies but that the boost is modest and may not be sufficient to alter disease course.


Subject(s)
COVID-19 , Leukocytes, Mononuclear , Humans , COVID-19/therapy , COVID-19 Serotherapy , Antibodies, Neutralizing , Adaptive Immunity
4.
Am J Emerg Med ; 68: 47-51, 2023 06.
Article in English | MEDLINE | ID: covidwho-2280209

ABSTRACT

STUDY OBJECTIVE: During the COVID-19 pandemic, prescribing supplemental oxygen was a common reason for hospitalization of patients. We evaluated outcomes of COVID-19 patients discharged from the Emergency Department (ED) with home oxygen as part of a program to decrease hospital admissions. METHODS: We retrospectively observed COVID-19 patients with an ED visit resulting in direct discharge or observation from April 2020 to January 2022 at 14 hospitals in a single healthcare system. The cohort included those discharged with new oxygen supplementation, a pulse oximeter, and return instructions. Our primary outcome was subsequent hospitalization or death outside the hospital within 30 days of ED or observation discharge. RESULTS: Among 28,960 patients visiting the ED for COVID-19, providers admitted 11,508 (39.7%) to the hospital, placed 907 (3.1%) in observation status, and discharged 16,545 (57.1%) to home. A total of 614 COVID-19 patients (535 discharge to home and 97 observation unit) went home on new oxygen therapy. We observed the primary outcome in 151 (24.6%, CI 21.3-28.1%) patients. There were 148 (24.1%) patients subsequently hospitalized and 3 (0.5%) patients who died outside the hospital. The subsequent hospitalized mortality rate was 29.7% with 44 of the 148 patients admitted to the hospital dying. Mortality all cause at 30 days in the entire cohort was 7.7%. CONCLUSIONS: Most patients discharged to home with new oxygen for COVID-19 safely avoid later hospitalization and few patients die within 30 days. This suggests the feasibility of the approach and offers support for ongoing research and implementation efforts.


Subject(s)
COVID-19 , Humans , COVID-19/epidemiology , COVID-19/therapy , Retrospective Studies , Pandemics , Hospitalization , Patient Discharge , Emergency Service, Hospital , Oxygen Inhalation Therapy , Oxygen/therapeutic use
5.
N Engl J Med ; 385(21): 1951-1960, 2021 11 18.
Article in English | MEDLINE | ID: covidwho-1361668

ABSTRACT

BACKGROUND: Early administration of convalescent plasma obtained from blood donors who have recovered from coronavirus disease 2019 (Covid-19) may prevent disease progression in acutely ill, high-risk patients with Covid-19. METHODS: In this randomized, multicenter, single-blind trial, we assigned patients who were being treated in an emergency department for Covid-19 symptoms to receive either one unit of convalescent plasma with a high titer of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or placebo. All the patients were either 50 years of age or older or had one or more risk factors for disease progression. In addition, all the patients presented to the emergency department within 7 days after symptom onset and were in stable condition for outpatient management. The primary outcome was disease progression within 15 days after randomization, which was a composite of hospital admission for any reason, seeking emergency or urgent care, or death without hospitalization. Secondary outcomes included the worst severity of illness on an 8-category ordinal scale, hospital-free days within 30 days after randomization, and death from any cause. RESULTS: A total of 511 patients were enrolled in the trial (257 in the convalescent-plasma group and 254 in the placebo group). The median age of the patients was 54 years; the median symptom duration was 4 days. In the donor plasma samples, the median titer of SARS-CoV-2 neutralizing antibodies was 1:641. Disease progression occurred in 77 patients (30.0%) in the convalescent-plasma group and in 81 patients (31.9%) in the placebo group (risk difference, 1.9 percentage points; 95% credible interval, -6.0 to 9.8; posterior probability of superiority of convalescent plasma, 0.68). Five patients in the plasma group and 1 patient in the placebo group died. Outcomes regarding worst illness severity and hospital-free days were similar in the two groups. CONCLUSIONS: The administration of Covid-19 convalescent plasma to high-risk outpatients within 1 week after the onset of symptoms of Covid-19 did not prevent disease progression. (SIREN-C3PO ClinicalTrials.gov number, NCT04355767.).


Subject(s)
COVID-19/therapy , Disease Progression , SARS-CoV-2/immunology , Adolescent , Adult , Aged , Aged, 80 and over , Antibodies, Neutralizing/blood , Antibodies, Viral/blood , COVID-19/complications , COVID-19/immunology , COVID-19/mortality , Emergency Service, Hospital , Female , Hospitalization , Humans , Immunization, Passive , Infusions, Intravenous , Male , Middle Aged , Risk Factors , Single-Blind Method , Treatment Failure , Young Adult , COVID-19 Serotherapy
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