Trial · NCT05877508

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

NCT05877508, Phase 2, Active not recruiting, Michael Peluso, MD; results first posted 2025-10-28

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Anti-SARS-CoV-2 Monoclonal Antibodies for Long COVID (COVID-19). Trials, record NCT05877508. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05877508

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Anti-SARS-CoV-2 Monoclonal Antibodies for Long COVID (COVID-19)
NCT number: NCT05877508
Status: Active not recruiting
Phases: Phase 2
Enrollment: 36 participants, actual
Lead sponsor: Michael Peluso, MD
Conditions: Long COVID, Post-Acute Sequela of COVID-19, Post-Acute COVID-19
Interventions: AER002, Placebo
First posted: 2023-05-26
Last updated: 2025-10-28
Results first posted: 2025-10-28
Limitations and caveats: This is a small proof-of-concept study.

Source ClinicalTrials.gov

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score	Day 90	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.
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score	Day 30 and Day 180	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 30 and Day 180 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.
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score	Day 90	This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean PROMIS-29 Mental 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 mental health.
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score	Day 30 and Day 180	This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean PROMIS-29 Mental Health Summary Score at Day 30 and Day 180 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 mental health.
Secondary	Quality of Life (Global Health Score) 100-point Visual-Analogue Scale	Day 90	This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in the baseline adjusted mean Quality of Life 100-point Visual-Analogue-Scale at Day 90 post-infusion. 0 represents the worst health a person can imagine and 100 represents the best health a person can imagine.
Secondary	Quality of Life (5-Item EuroQol EQ-5D-5L) Index Value Score	Day 90	This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean Quality of Life (5-Item EuroQol EQ-5D-5L) Index Value Score at Day 90 post-infusion. 5-Item EuroQol EQ-5D-5L questions assess pain/difficulty in day-to-day activities over the past week. The 5-Item EuroQol EQ-5D-5L produces a score that typically ranges from 0 - 1, with a higher score indicating better quality of life.
Secondary	Duke Activity Status Index (DASI)	Day 90	This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean DASI at Day 90 post-infusion. The Duke Activity Status Index is a patient-reported estimate of functional capacity, maximal oxygen consumption (VO2 max) and maximum metabolic equivalent of tasks (METs). The DASI questionnaire produces a score between 0 and 58.2 points, which is linearly correlated with a patient's VO2 max and METs, as measured from cardiopulmonary exercise testing (CPET). It inquires about a person's ability to perform self-care, walk, climb stairs, run, do house and yard work, engage in sexual intercourse, and perform moderate recreational activities. A higher score indicates higher functional capacity.
Secondary	Composite Autonomic Symptom Score-31 (COMPASS-31)	Day 90	This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean COMPASS-31 score at Day 90 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. The total score ranges from 0 to 100 and a higher score indicates more severe autonomic dysfunction.
Secondary	World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2.0)	Day 90	This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean WHO-DAS 2.0 score at Day 90 post-infusion. The World Health Organization Disability Assessment Schedule 2.0 questionnaire asks about difficulties due to health conditions. Health conditions include diseases or illnesses, other health problems that may be short or long lasting, injuries, mental or emotional problems, and problems with alcohol or drugs. The range is scored from 0-48, with a higher score indicating a higher level of disability.
Secondary	Patient Global Impression of Change (PGIC) Scale	Day 90	This measure will evaluate whether there is a difference between treatment with AER002 versus placebo on the Patient Global Impression of Change (PGIC) scale at Day 90 post-infusion. The self-reported PGIC reflects a patient's belief about the efficacy of treatment. We used a modified PGIC scale which has been used to study pain syndromes and has been employed in other Long COVID clinical trials. It is a common data element developed by the National Institutes of Mental Health. The PGIC ranges from 0 (Much better) to 10 (Much Worse). A score of 5 indicates no change.

1 to 10 of 18Source ClinicalTrials.gov

See all 18 registered outcomes

Outcomes18

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score	Day 90	score on a scale	MEAN
SECONDARY	Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score	Day 30 and Day 180	score on a scale	MEAN
SECONDARY	Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score	Day 90	score on a scale	MEAN
SECONDARY	Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score	Day 30 and Day 180	score on a scale	MEAN
SECONDARY	Quality of Life (Global Health Score) 100-point Visual-Analogue Scale	Day 90	units on a scale	MEAN
SECONDARY	Quality of Life (5-Item EuroQol EQ-5D-5L) Index Value Score	Day 90	score on a scale	MEAN
SECONDARY	Duke Activity Status Index (DASI)	Day 90	score on a scale	MEAN
SECONDARY	Composite Autonomic Symptom Score-31 (COMPASS-31)	Day 90	score on a scale	MEAN
SECONDARY	World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2.0)	Day 90	score on a scale	MEAN
SECONDARY	Patient Global Impression of Change (PGIC) Scale	Day 90	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 18Source ClinicalTrials.gov

See all 18 outcomes

Results by group62

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score	AER002		40.9	95% Confidence Interval 38.3 to 43.5	score on a scale
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score	Placebo		45.0	95% Confidence Interval 41.3 to 48.6	score on a scale
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score	AER002	Day 30	40.7	95% Confidence Interval 38.1 to 43.3	score on a scale
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score	Placebo	Day 30	41.7	95% Confidence Interval 38.0 to 45.4	score on a scale
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score	AER002	Day 180	41.7	95% Confidence Interval 39.1 to 44.3	score on a scale
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score	Placebo	Day 180	44.4	95% Confidence Interval 40.7 to 48.0	score on a scale
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score	AER002		40.7	95% Confidence Interval 37.9 to 43.5	score on a scale
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score	Placebo		45.4	95% Confidence Interval 41.4 to 49.4	score on a scale
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score	AER002	Day 30	40.3	95% Confidence Interval 37.5 to 43.1	score on a scale
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score	Placebo	Day 30	42.7	95% Confidence Interval 38.7 to 46.7	score on a scale

1 to 10 of 62Source ClinicalTrials.gov

See all 62 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	AER002	24
Overall Study	STARTED	Placebo	12
Overall Study	COMPLETED	AER002	24
Overall Study	COMPLETED	Placebo	12
Overall Study	NOT COMPLETED	AER002	0
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events118

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Rebound COVID-19	Infections and infestations	AER002	0	24
other	Rebound COVID-19	Infections and infestations	Placebo	1	12
other	Small intestinal bacterial overgrowth	Infections and infestations	AER002	0	24
other	Small intestinal bacterial overgrowth	Infections and infestations	Placebo	1	12
other	Suspected oral infection	Infections and infestations	AER002	0	24
other	Suspected oral infection	Infections and infestations	Placebo	1	12
other	Decreased fibrinogen	Blood and lymphatic system disorders	AER002	2	24
other	Decreased fibrinogen	Blood and lymphatic system disorders	Placebo	0	12
other	Hypoglycemia	Metabolism and nutrition disorders	AER002	1	24
other	Hypoglycemia	Metabolism and nutrition disorders	Placebo	0	12

1 to 10 of 118Source ClinicalTrials.gov

See all 118 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AER002	0	24
Total, all-cause mortality	Placebo	0	12
Total, other adverse events	AER002	21	24
Total, other adverse events	Placebo	12	12
Total, serious adverse events	AER002	0	24
Total, serious adverse events	Placebo	0	12

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39536121	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
AER002 vs Placebo: deaths from any cause	Trial comparisons
AER002 vs Placebo: serious adverse events	Trial comparisons

Tests2

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Continuous Performance Test	Secondary outcome	ConductCognition
Stroop Color-Word Test	Secondary outcome	ConductCognition

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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