Post-acute COVID-19 (PACS), or "long COVID" SyndromeMAbPACsNCT05013723
Impact of Monoclonal Antibody Treatment on Post-Acute COVID-19 Syndrome
An observational study of Post-acute COVID-19 (PACS), or "long COVID" Syndrome, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-acute COVID-19 (PACS), or "long COVID" Syndrome
- What is being tested?
- Surveys
- Type of treatment
- Injection or infusion
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2021to 16 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- Unwilling to participate
- Not able to understand the English language survey questions
- Prisoners
- Inadequate cognitive capacity to provide consent and complete the survey
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Surveys
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveysOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Patients who received casirivimab-imdevimab antibody infusion Receives: Other: Surveys | |
| Control | Matched control group who did not receive MAb, matched on diagnosis date, age, gender and Utah COVID-19 Risk Score Receives: Other: Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-acute COVID-19 symptom score (out of 60)
Post-acute COVID-19 symptom score (out of 60)
Measured: Between day 60 and day 90 from date of positive test
Secondary outcomes (8)
Medically attended visits
Number of medically attended visits between day 60 and day 90 from date of positive test
Measured: Between day 60 and day 90 from date of positive test
Healthcare costs
Total healthcare costs to health system
Measured: Between day 60 and day 90 from date of positive test
Diagnostic test costs
Total diagnostic test costs to health system
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Between day 60 and day 90 from date of positive test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start30 Aug 2021
- Primary completion16 Dec 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-acute COVID-19 (PACS), or "long COVID" SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013723
- Sponsor's protocol ID
- MAbPACs
- Acronym
- MAbPACs
- Status last verified
- Nov 2024
- First submitted
- 2 Aug 2021
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Monoclonal Antibody Treatment on Post-Acute COVID-19 Syndrome
- ClinicalTrials.gov ID
- NCT05013723
- Acronym / sponsor ID
- MAbPACs / MAbPACs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Other: SurveysPatients who received casirivimab-imdevimab antibody infusion |
| Control | – | Other: SurveysMatched control group who did not receive MAb, matched on diagnosis date, age, gender and Utah COVID-19 Risk Score |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- Unwilling to participate
- Not able to understand the English language survey questions
- Prisoners
- Inadequate cognitive capacity to provide consent and complete the survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveysMental 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) | Other | Control, Intervention |
Primary outcome
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)
8 secondary outcomes
Medically attended visits
Time frame: Between day 60 and day 90 from date of positive test
Healthcare costs
Time frame: Between day 60 and day 90 from date of positive test
Diagnostic test costs
Time frame: Between day 60 and day 90 from date of positive test
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
Post COVID-19 Function Status Scale
Time frame: Between day 60 and day 90 from date of positive test
Mental health validated psychometric survey: Anxiety (GAD-7)
Time frame: Between day 60 and day 90 from date of positive test
Quality of life (SF-12)
Time frame: Between day 60 and day 90 from date of positive test
Primary Care Post-Traumatic Stress Disorder 5
Time frame: Between day 60 and day 90 from date of positive test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-acute COVID-19 (PACS), or "long COVID" Syndrome, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-acute COVID-19 symptom score (out of 60) (time frame: Between day 60 and day 90 from date of positive test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.