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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Post-acute COVID-19 (PACS), or Long COVID Syndrome

Intervention / Treatment
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* Other: Surveys


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention<br>Patients who received casirivimab-imdevimab antibody infusion | Other: Surveys<br>* Mental health validated psychometric surveys: Depression (PHQ-9), Anxiety (GAD-7), PTSD (PC-PTSD-5) Quality of Life surveys: Post COVID-19 Function Status Scale, Quality of life (SF-12)<br>|
| Control<br>Matched control group who did not receive MAb, matched on diagnosis date, age, gender and Utah COVID-19 Risk Score | Other: Surveys<br>* Mental health validated psychometric surveys: Depression (PHQ-9), Anxiety (GAD-7), PTSD (PC-PTSD-5) Quality of Life surveys: Post COVID-19 Function Status Scale, Quality of life (SF-12)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-acute COVID-19 symptom score (out of 60) | Post-acute COVID-19 symptom score (out of 60) | Between day 120 and day 150 from date of positive test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medically attended visits | Number of medically attended visits between day 120 and day 150 from date of positive test | Between day 120 and day 150 from date of positive test | 
| Healthcare costs | Total healthcare costs to health system | Between day 120 and day 150 from date of positive test | 
| Diagnostic test costs | Total diagnostic test costs to health system | Between day 120 and day 150 from date of positive test | 
| Mental health validated psychometric surveys: Depression (PHQ-9),PTSD (PC-PTSD-5) | Depression (PHQ-9) score. Range (0-27). Lower scores indicate better health | Between day 120 and day 150 from date of positive test | 
| Post COVID-19 Function Status Scale | Quality of Life surveys: Post COVID-19 Function Status Scale. Range (0-4), lower score indicates better health | Between day 120 and day 150 from date of positive test | 
| Mental health validated psychometric survey: Anxiety (GAD-7) | Anxiety (GAD-7) score (Range 0 -21). Lower scores indicate better health | Between day 120 and day 150 from date of positive test | 
| Quality of life (SF-12) | SF-12 Short Form 12. Range (0-64), high scores indicate better health | Between day 120 and day 150 from date of positive test | 
| Primary Care Post-Traumatic Stress Disorder 5 | PTSD-5. Range (0-5); lower scores indicate better health | Between day 120 and day 150 from date of positive test |