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

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.

Study Overview

• Status: Completed
• Conditions: Post-acute COVID-19 (PACS), or "long COVID" Syndrome
• Intervention / Treatment: Other: Surveys

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

• Study Type: Observational
• Enrollment (Actual): 260

Contacts and Locations

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84157
      • Intermountain Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention; Patients who received casirivimab-imdevimab antibody infusion	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)
Control; 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)

What is the study measuring?

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 60 and day 90 from date of positive test

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medically attended visits	Number of medically attended visits between day 60 and day 90 from date of positive test	Between day 60 and day 90 from date of positive test
Healthcare costs	Total healthcare costs to health system	Between day 60 and day 90 from date of positive test
Diagnostic test costs	Total diagnostic test costs to health system	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	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	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	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	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	Between day 60 and day 90 from date of positive test

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Collaborators: Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Actual): December 16, 2022
• Study Completion (Actual): December 16, 2022

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 5, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Post-Infectious Disorders; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Disease; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Post-Acute COVID-19 Syndrome; Syndrome
• Other Study ID Numbers: MAbPACs

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No