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Anti-SARS-CoV-2 Monoclonal Antibodies for Long COVID (COVID-19) (outSMART-LC)

Primary Purpose

Long COVID, Post-Acute Sequela of COVID-19, Post-Acute COVID-19

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AER002
Placebo
Sponsored by
Michael Peluso, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Long COVID focused on measuring COVID-19, Long COVID, Post-acute Sequelae of SARS-CoV-2 infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria: Male, female, or transgender ≥18 years of age at Screening. History of confirmed acute SARS-CoV-2 infection. Long COVID attributed to a SARS-CoV-2 infection with a variant against which AER002 is known to have neutralizing activity (prior to August 15, 2022). Note: While individuals re-infected with SARS-CoV-2 after August 15, 2022 will not be excluded, the SARS-CoV-2 infection after which Long COVID symptoms began must pre-date August 15, 2022. At least two symptoms that are new or worsened since the time of SARS-CoV-2 infection, not known to be attributable to another cause upon assessment by the PI. Symptoms must have been present for at least 60 days prior to screening and must be reported to be at least somewhat bothersome. Body mass index (BMI) 18 to 50 kilograms/meter squared (kg/m2), inclusive, at the time of screening. Participants who are of childbearing potential (CBP) and male participants with sexual partner(s) who are females of CBP must agree to use adequate contraception from study consent through 360 days after dosing. Key Exclusion Criteria: Long COVID attributed to a SARS-CoV-2 infection after August 15, 2022. Previously received treatment or prophylaxis with a SARS-CoV-2-specific mAb, or plan to receive such treatment before exiting the study. Previously received COVID-19 convalescent plasma treatment within 60 days prior to Day 0 or plan to receive such treatment before exiting the study. Plans to receive any investigational or approved vaccine or booster for SARS-CoV-2 within 60 days prior to Day 0 or before Day 30 following Day 0. Active cardiovascular disease or recent (within 3 months) stroke. Recent (within 6 months) or planned major surgery. Currently hospitalized or recent (within 1 month) unplanned hospitalization. Active Hepatitis Bor C infection . Untreated or unstable HIV infection (two or more consecutive plasma HIV RNA values >48 copies/mL in the 6 months prior to screen). Severe coagulopathy (international normalized ratio ((INR) >2.0, history of hemophilia). Severe anemia (hemoglobin <9 grams/deciliter (g/dL)). Moderate or severe immunocompromise, according to the current NIH COVID-19 Treatment Guidelines as of March 6, 2023. History of anaphylaxis or hypersensitivity upon receiving IV antibody infusions, any componenets of the intervention, prescription or non-prescription drugs, or food products in the past. Pregnant, breastfeeding, or unwilling to practice birth control abide by the contraception requirements outlined in the inclusion criteria. Participation in a clinical trial with receipt of an investigational product within 28 days or 5 half-lives (whichever is longer) prior to Day 0. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Sites / Locations

  • UCSF/Zuckerberg San Francisco General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AER002

Placebo

Arm Description

AER002 1200mg administered once by IV

Placebo administered once by IV

Outcomes

Primary Outcome Measures

Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Score from Baseline.
This measure will evaluate whether there is a difference between treatment with AER002 versus placebo on the PROMIS-29 scale between baseline and 3 months post-infusion. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do).

Secondary Outcome Measures

Full Information

First Posted
May 24, 2023
Last Updated
August 1, 2023
Sponsor
Michael Peluso, MD
Collaborators
Aerium Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05877508
Brief Title
Anti-SARS-CoV-2 Monoclonal Antibodies for Long COVID (COVID-19)
Acronym
outSMART-LC
Official Title
An Exploratory, Randomized, Double-Blind Placebo-Controlled Study to Assess the Safety of an Anti-SARS-CoV-2 Monoclonal Antibody and Response to Treatment in Individuals With Long COVID (outSMART-LC)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Peluso, MD
Collaborators
Aerium Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Persistent viral infection with viral reservoirs and detection of circulating spike protein after the initial acute illness is one potential pathogenic mechanism for Long COVID. This mechanism may be able to be targeted by SARS-CoV-2 monoclonal antibodies (mAbs). This trial will study the safety and efficacy of AER002 to treat individuals with Long COVID in an adult population.
Detailed Description
The study will enroll approximately 30 participants who meet the World Health Organization (WHO) Long COVID criteria, with Long COVID attributed to a SARS-CoV-2 variant susceptible to AER002. Participants will be enrolled at a single center and randomized 2:1 to receive a SARS-CoV-2 monoclonal antibody (AER002) 1200mg or placebo. Evaluations will take place at baseline and at timepoints up to 1-year post-infusion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long COVID, Post-Acute Sequela of COVID-19, Post-Acute COVID-19
Keywords
COVID-19, Long COVID, Post-acute Sequelae of SARS-CoV-2 infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AER002
Arm Type
Experimental
Arm Description
AER002 1200mg administered once by IV
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered once by IV
Intervention Type
Drug
Intervention Name(s)
AER002
Intervention Description
Intravenous infusion of AER002
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo infusion
Primary Outcome Measure Information:
Title
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Score from Baseline.
Description
This measure will evaluate whether there is a difference between treatment with AER002 versus placebo on the PROMIS-29 scale between baseline and 3 months post-infusion. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do).
Time Frame
Baseline and 3 months post-infusion.
Other Pre-specified Outcome Measures:
Title
Change in Composite Autonomic Symptom Score (COMPASS-31) Score from Baseline.
Description
This measure will evaluate whether there is a difference between treatment with AER002 versus placebo on the COMPASS-31 scale between baseline and 3 months post-infusion. COMPASS-31 asks 31 questions related to autonomic dysfunction. The answer to each question generates a numeric score for the question, which is then summed at the end of the questionnaire. A total score out of 100 is generated summarizing orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, urinary, pupillomotor, temperature intolerance, and sexual impairment.
Time Frame
Baseline and 3 months post-infusion.
Title
Distance walked on 6 minute walk test (6MWT).
Description
This measure will evaluate whether there is a difference between treatment with AER002 versus placebo on 6MWT performance between baseline and at 3 months post-infusion. The 6MWT requires an individual to walk at their normal pace for 6 minutes on a marked track (for example, a hallway). Vital signs are assessed, and the total distance covered is the primary outcome of interest.
Time Frame
Baseline and 3 months post-infusion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Male, female, or transgender ≥18 years of age at Screening. History of confirmed acute SARS-CoV-2 infection. Long COVID attributed to a SARS-CoV-2 infection with a variant against which AER002 is known to have neutralizing activity (prior to August 15, 2022). Note: While individuals re-infected with SARS-CoV-2 after August 15, 2022 will not be excluded, the SARS-CoV-2 infection after which Long COVID symptoms began must pre-date August 15, 2022. At least two symptoms that are new or worsened since the time of SARS-CoV-2 infection, not known to be attributable to another cause upon assessment by the PI. Symptoms must have been present for at least 60 days prior to screening and must be reported to be at least somewhat bothersome. Body mass index (BMI) 18 to 50 kilograms/meter squared (kg/m2), inclusive, at the time of screening. Participants who are of childbearing potential (CBP) and male participants with sexual partner(s) who are females of CBP must agree to use adequate contraception from study consent through 360 days after dosing. Key Exclusion Criteria: Long COVID attributed to a SARS-CoV-2 infection after August 15, 2022. Previously received treatment or prophylaxis with a SARS-CoV-2-specific mAb, or plan to receive such treatment before exiting the study. Previously received COVID-19 convalescent plasma treatment within 60 days prior to Day 0 or plan to receive such treatment before exiting the study. Plans to receive any investigational or approved vaccine or booster for SARS-CoV-2 within 60 days prior to Day 0 or before Day 30 following Day 0. Active cardiovascular disease or recent (within 3 months) stroke. Recent (within 6 months) or planned major surgery. Currently hospitalized or recent (within 1 month) unplanned hospitalization. Active Hepatitis Bor C infection . Untreated or unstable HIV infection (two or more consecutive plasma HIV RNA values >48 copies/mL in the 6 months prior to screen). Severe coagulopathy (international normalized ratio ((INR) >2.0, history of hemophilia). Severe anemia (hemoglobin <9 grams/deciliter (g/dL)). Moderate or severe immunocompromise, according to the current NIH COVID-19 Treatment Guidelines as of March 6, 2023. History of anaphylaxis or hypersensitivity upon receiving IV antibody infusions, any componenets of the intervention, prescription or non-prescription drugs, or food products in the past. Pregnant, breastfeeding, or unwilling to practice birth control abide by the contraception requirements outlined in the inclusion criteria. Participation in a clinical trial with receipt of an investigational product within 28 days or 5 half-lives (whichever is longer) prior to Day 0. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael J Peluso, MD
Phone
414-476-4082
Ext
119
Email
michael.peluso@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Study Email
Email
outsmartLC@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Peluso, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF/Zuckerberg San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UCSF Study Team
Phone
415-476-4082
Ext
144
Email
outsmartLC@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Michael J Peluso, MD
First Name & Middle Initial & Last Name & Degree
Steven G Deeks, MD
First Name & Middle Initial & Last Name & Degree
Timothy J Henrich, MD
First Name & Middle Initial & Last Name & Degree
Priscilla Y Hsue, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Anti-SARS-CoV-2 Monoclonal Antibodies for Long COVID (COVID-19)

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