Post-acute COVID-19 (PACS), or long COVID Syndrome
Conditions
Brief summary
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.
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 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
Interventions
OTHERSurveys
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)
Sponsors
Intermountain Health Care, Inc.
Regeneron Pharmaceuticals
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 * 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)
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-acute COVID-19 symptom score (out of 60) | Between day 60 and day 90 from date of positive test | Post-acute COVID-19 symptom score (out of 60) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healthcare costs | Between day 60 and day 90 from date of positive test | Total healthcare costs to health system |
| Diagnostic test costs | Between day 60 and day 90 from date of positive test | Total diagnostic test costs to health system |
| Mental health validated psychometric surveys: Depression (PHQ-9),PTSD (PC-PTSD-5) | Between day 60 and day 19 from date of positive test | Depression (PHQ-9) score. Range (0-27). Lower scores indicate better health |
| Medically attended visits | Between day 60 and day 90 from date of positive test | Number of medically attended visits 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 | Anxiety (GAD-7) score (Range 0 -21). Lower scores indicate better health |
| Quality of life (SF-12) | Between day 60 and day 90 from date of positive test | SF-12 Short Form 12. Range (0-64), high scores indicate better health |
| Primary Care Post-Traumatic Stress Disorder 5 | Between day 60 and day 90 from date of positive test | PTSD-5. Range (0-5); lower scores indicate better health |
| Post COVID-19 Function Status Scale | Between day 60 and day 90 from date of positive test | Quality of Life surveys: Post COVID-19 Function Status Scale. Range (0-4), lower score indicates better health |
Countries
United States
Outcome results
None listed