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

NCT05013723 | Completed

• 1 other identifier: MAbPACs
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-acute COVID-19 (PACS), or "long COVID" Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Medically attended visits

  Between day 60 and day 90 from date of positive test

• Healthcare costs

  Between day 60 and day 90 from date of positive test

• Diagnostic test costs

  Between day 60 and day 90 from date of positive test

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

  Between day 60 and day 19 from date of positive test

• Post COVID-19 Function Status Scale

  Between day 60 and day 90 from date of positive test

Study Arms (2)

Intervention

Patients who received casirivimab-imdevimab antibody infusion

Other: Surveys

Control

Matched control group who did not receive MAb, matched on diagnosis date, age, gender and Utah COVID-19 Risk Score

Other: Surveys

Interventions

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)

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• Unwilling to participate
• Not able to understand the English language survey questions
• Prisoners
• Inadequate cognitive capacity to provide consent and complete the survey

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 19, 2021
• Study Start: August 30, 2021
• Primary Completion: December 16, 2022
• Study Completion: December 16, 2022
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)