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Completed

NCT Number: NCT05013723

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

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surveys

Other

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)

Primary outcomes

  1. Post-acute COVID-19 symptom score (out of 60)

    Time frame: Between day 60 and day 90 from date of positive test

    Post-acute COVID-19 symptom score (out of 60)

Secondary outcomes

  1. Medically attended visits

    Time frame: 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

  2. Healthcare costs

    Time frame: Between day 60 and day 90 from date of positive test

    Total healthcare costs to health system

  3. Diagnostic test costs

    Time frame: Between day 60 and day 90 from date of positive test

    Total diagnostic test costs to health system

  4. Mental health validated psychometric surveys: Depression (PHQ-9),PTSD (PC-PTSD-5)

    Time frame: Between day 60 and day 19 from date of positive test

    Depression (PHQ-9) score. Range (0-27). Lower scores indicate better health

  5. Post COVID-19 Function Status Scale

    Time frame: 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

  6. Mental health validated psychometric survey: Anxiety (GAD-7)

    Time frame: Between day 60 and day 90 from date of positive test

    Anxiety (GAD-7) score (Range 0 -21). Lower scores indicate better health

  7. Quality of life (SF-12)

    Time frame: Between day 60 and day 90 from date of positive test

    SF-12 Short Form 12. Range (0-64), high scores indicate better health

  8. Primary Care Post-Traumatic Stress Disorder 5

    Time frame: Between day 60 and day 90 from date of positive test

    PTSD-5. Range (0-5); lower scores indicate better health

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Acronym: MAbPACs

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 19, 2021
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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