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临床试验/NCT05013723
NCT05013723已完成不适用

Impact of Monoclonal Antibody Treatment on Post-Acute COVID-19 Syndrome

Intermountain Health Care, Inc.1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2021年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
260
试验地点
1
主要终点
Post-acute COVID-19 symptom score (out of 60)

研究概览

简要总结

Use the Intermountain real-world MAb-treatment registry and control group to prospectively evaluate PACS symptoms at least 60 days after initial COVID-19 diagnosis.

详细描述

It is now recognized that many patients who develop symptomatic COVID-19 infection continue to suffer from a variety of symptoms that persist well after the acute syndrome. This has been called post-acute COVID-19 (PACS), or "long COVID" syndrome. In a meta-analysis of studies of hospitalized patients, 70% of patients reported PACS symptoms 60 days after diagnosis. Patients with non-severe COVID-19 appear to have lower rates of PACS symptoms, although a recent study suggested that at 4 months follow-up, 28% of patients still reported at least one symptom. PACS is associated with significant morbidity, decreased quality of life, mental and behavioral health impact and healthcare cost. Neither the pathophysiology nor risk factors for PACS are well-understood and further research is needed to characterize this syndrome. Some studies have suggested that age, female gender, obesity, comorbid burden, symptoms at diagnosis and hospitalization during acute COVID-19 increase risk for PACS. Because of the significant overall impact of PACS, there is significant interest in identifying therapies to prevent this condition. Early neutralizing therapy with anti-SARS-CoV-2 monoclonal antibodies (MAbs) addresses the initial phase of disease and has now been shown to be effective at decreasing viral load and preventing progression to severe disease, hospitalization and death.

Understanding how MAb therapy may impact PACS symptoms is important to determining usage and value of these products and an important contribution to our understanding of how to prevent PACS.

Study Design: Prospective electronic survey using matched case-control design

Objective

Use the Intermountain real-world MAb-treatment registry and control group to prospectively evaluate PACS symptoms at least 60 days after initial COVID-19 diagnosis. Aim 1: Determine whether ambulatory patients who received monoclonal antibody infusion for early symptomatic COVID-19 have fewer persistent symptoms of post-acute COVID-19 ("long COVID") syndrome at least 60 days after initial diagnosis.

Hypothesis

MAb therapy is associated with significantly less post-acute COVID-19 (PACS) symptoms at 120 days post diagnosis Aim 2: Explore predictors associated with PACS symptoms in high risk patients Hypothesis: Hospitalization, age, obesity, number of comorbidities and symptoms at diagnosis predict PACS

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Positive antigen or polymerase chain reaction test for SARS-CoV-2
  • Symptomatic COVID-19
  • Between day 60 and day 90 from date of positive test
  • Not hospitalized or hypoxemic by day 7 of symptoms (Aim 1 only)

排除标准

  • Unwilling to participate
  • Not able to understand the English language survey questions
  • Prisoners
  • Inadequate cognitive capacity to provide consent and complete the survey

结局指标

主要结局

Post-acute COVID-19 symptom score (out of 60)

时间窗: Between day 60 and day 90 from date of positive test

Post-acute COVID-19 symptom score (out of 60)

次要结局

  • Medically attended visits(Between day 60 and day 90 from date of positive test)
  • Healthcare costs(Between day 60 and day 90 from date of positive test)
  • Diagnostic test costs(Between day 60 and day 90 from date of positive test)
  • Mental health validated psychometric surveys: Depression (PHQ-9),PTSD (PC-PTSD-5)(Between day 60 and day 19 from date of positive test)
  • Post COVID-19 Function Status Scale(Between day 60 and day 90 from date of positive test)
  • Mental health validated psychometric survey: Anxiety (GAD-7)(Between day 60 and day 90 from date of positive test)
  • Quality of life (SF-12)(Between day 60 and day 90 from date of positive test)
  • Primary Care Post-Traumatic Stress Disorder 5(Between day 60 and day 90 from date of positive test)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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