Impact of Monoclonal Antibody Treatment on Post-Acute COVID-19 Syndrome
Purpose
Use the Intermountain real-world MAb-treatment registry and control group to prospectively evaluate PACS symptoms at least 120 days after initial COVID-19 diagnosis.
Condition
- Post-acute COVID-19 (PACS), or "Long COVID" Syndrome
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age ≥18 - Positive antigen or polymerase chain reaction test for SARS-CoV-2 December 1, 2020 to April 15, 2021 - Symptomatic COVID-19 - Between day 120 and day 150 from date of positive test - Not hospitalized or hypoxemic by day 7 of symptoms (Aim 1 only)
Exclusion Criteria
- Unwilling to participate - Not able to understand the English language survey questions - Prisoners - Inadequate cognitive capacity to provide consent and complete the survey
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Control
- Time Perspective
- Retrospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Intervention | Patients who received casirivimab-imdevimab antibody infusion |
|
| Control | Matched control group who did not receive MAb, matched on diagnosis date, age, gender and Utah COVID-19 Risk Score |
|
Recruiting Locations
More Details
- NCT ID
- NCT05013723
- Status
- Unknown status
- Sponsor
- Intermountain Health Care, Inc.
Detailed Description
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 120 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 120 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