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

NCT05877508 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 1 other identifier: 23-38629
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score

  This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean PROMIS-29 Physical Health Summary Score at Day 90 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). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse physical health.

  Day 90

Secondary Outcomes (17)

• Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score

  Day 30 and Day 180

• Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score

  Day 90

• Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score

  Day 30 and Day 180

• Quality of Life (Global Health Score) 100-point Visual-Analogue Scale

  Day 90

• Quality of Life (5-Item EuroQol EQ-5D-5L) Index Value Score

  Day 90

Study Arms (2)

AER002

EXPERIMENTAL

AER002 1200mg administered once by IV

Drug: AER002

Placebo

PLACEBO COMPARATOR

Placebo administered once by IV

Other: Placebo

Interventions

AER002 DRUG

Intravenous infusion of AER002

AER002

Placebo OTHER

Placebo infusion

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Michael Peluso, MD: lead
• Aerium Therapeutics: collaborator
• Patient-Led Research Collaborative: collaborator
• PolyBio Research Foundation: collaborator

Study Sites (1)

UCSF/Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (1)

• Peluso MJ, Hanson MR, Deeks SG. Infection-associated chronic conditions: Why Long Covid is our best chance to untangle Osler's web. Sci Transl Med. 2024 Nov 13;16(773):eado2101. doi: 10.1126/scitranslmed.ado2101. Epub 2024 Nov 13.

  PMID: 39536121 DERIVED

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

This is a small proof-of-concept study.

Results Point of Contact

• Title: Michael Peluso
• Organization: University of California San Francisco

michael.peluso@ucsf.edu

(415) 502-2449

Study Officials

• Michael J Peluso, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Medicine

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: May 26, 2023
• Study Start: August 1, 2023
• Primary Completion: July 29, 2024
• Study Completion (Estimated): July 31, 2026
• Last Updated: October 28, 2025
• Results First Posted: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)