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

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ClinicalTrials.gov Identifier: NCT05013723
Recruitment Status : Not yet recruiting
First Posted : August 19, 2021
Last Update Posted : August 19, 2021
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Intermountain Health Care, Inc.

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.

Condition or disease Intervention/treatment
Post-acute COVID-19 (PACS), or "Long COVID" Syndrome 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 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

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Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Impact of Monoclonal Antibody Treatment on Post-Acute COVID-19 Syndrome
Estimated Study Start Date : August 23, 2021
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : April 1, 2022

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)




Primary Outcome Measures :
  1. Post-acute COVID-19 symptom score (out of 60) [ Time Frame: Between day 120 and day 150 from date of positive test ]
    Post-acute COVID-19 symptom score (out of 60)


Secondary Outcome Measures :
  1. Medically attended visits [ Time Frame: Between day 120 and day 150 from date of positive test ]
    Number of medically attended visits between day 120 and day 150 from date of positive test

  2. Healthcare costs [ Time Frame: Between day 120 and day 150 from date of positive test ]
    Total healthcare costs to health system

  3. Diagnostic test costs [ Time Frame: Between day 120 and day 150 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 120 and day 150 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 120 and day 150 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 120 and day 150 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 120 and day 150 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 120 and day 150 from date of positive test ]
    PTSD-5. Range (0-5); lower scores indicate better health



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 120 after positive test date but no greater than 150 days
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05013723


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

Locations
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United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157
Contact: Anne Haroldsen, CCRP    801-507-4707    Anne.Haroldsen@imail.org   
Contact: Jake Krong, CCRP    (801) 507-9333    Jake.Krong@imail.org   
Sub-Investigator: Brandon Webb, MD         
Sponsors and Collaborators
Intermountain Health Care, Inc.
Regeneron Pharmaceuticals
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Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT05013723    
Other Study ID Numbers: MAbPACs
First Posted: August 19, 2021    Key Record Dates
Last Update Posted: August 19, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Additional relevant MeSH terms:
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COVID-19
Syndrome
Disease
Pathologic Processes
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases