Clinical trial NCT05013723: Impact of Monoclonal Antibody Treatment on Post-Acute COVID-19 Syndrome
Official title: Impact of Monoclonal Antibody Treatment on Post-Acute COVID-19 Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-acute COVID-19 (PACS), or "long COVID" Syndrome
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2021-08-19
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Post-acute COVID-19 symptom score (out of 60)
timeFrame: Between day 60 and day 90 from date of positive test
Secondary outcomes:
measure: Medically attended visits
timeFrame: Between day 60 and day 90 from date of positive test
measure: Healthcare costs
timeFrame: Between day 60 and day 90 from date of positive test
measure: Diagnostic test costs
timeFrame: Between day 60 and day 90 from date of positive test
measure: Mental health validated psychometric surveys: Depression (PHQ-9),PTSD (PC-PTSD-5)
timeFrame: Between day 60 and day 19 from date of positive test
measure: Post COVID-19 Function Status Scale
timeFrame: Between day 60 and day 90 from date of positive test
measure: Mental health validated psychometric survey: Anxiety (GAD-7)
timeFrame: Between day 60 and day 90 from date of positive test
measure: Quality of life (SF-12)
timeFrame: Between day 60 and day 90 from date of positive test
measure: Primary Care Post-Traumatic Stress Disorder 5
timeFrame: Between day 60 and day 90 from date of positive test
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
References: