An observational study in Post-acute COVID-19 (PACS), or "long COVID" Syndrome, sponsored by Intermountain Health Care, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-07.
Sponsored by Intermountain Health Care, Inc. · Observational
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.
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
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 260 is close to the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Intermountain Health Care, Inc. is the lead sponsor of 118 studies on the registry; 15 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult patients with laboratory-confirmed acute COVID-19 in the Intermountain MAb registry, assessed at least 60 after positive test date but no greater than 90 days
Exclusion Criteria:
Patients who received casirivimab-imdevimab antibody infusion
Other: Surveys
Matched control group who did not receive MAb, matched on diagnosis date, age, gender and Utah COVID-19 Risk Score
Other: Surveys
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)
Post-acute COVID-19 symptom score (out of 60)
Post-acute COVID-19 symptom score (out of 60)
Time frame: Between day 60 and day 90 from date of positive test
Medically attended visits
Number of medically attended visits between day 60 and day 90 from date of positive test
Time frame: Between day 60 and day 90 from date of positive test
Healthcare costs
Total healthcare costs to health system
Time frame: Between day 60 and day 90 from date of positive test
Diagnostic test costs
Total diagnostic test costs to health system
Time frame: Between day 60 and day 90 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
Time frame: Between day 60 and day 19 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
Time frame: Between day 60 and day 90 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
Time frame: Between day 60 and day 90 from date of positive test
Quality of life (SF-12)
SF-12 Short Form 12. Range (0-64), high scores indicate better health
Time frame: Between day 60 and day 90 from date of positive test
Primary Care Post-Traumatic Stress Disorder 5
PTSD-5. Range (0-5); lower scores indicate better health
Time frame: Between day 60 and day 90 from date of positive test
Plan to share: No
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Intermountain Health Care, Inc.