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

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

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

Not yet recruiting
Post-acute COVID-19 (PACS), or "Long COVID" Syndrome

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)

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Intermountain Medical Center
Murray, Utah, United States

Investigator: Anne Haroldsen, CCRP
Contact: 801-507-4707
Anne.Haroldsen@imail.org

Investigator: Brandon Webb, MD

Contacts

Brandon Webb, MD
(801) 507-7781
Brandon.Webb@imail.org

Regeneron Pharmaceuticals
NCT Number
MeSH Terms
COVID-19
Post-Acute COVID-19 Syndrome
Syndrome