SARS-CoV-2 Specific Monoclonal Antibody for Post-COVID-19 Conditions (Long COVID)

NCT07021794 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: LongCovid Monoclonal Antibody
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This placebo-controlled, randomized, blinded, two-arm phase II study will test the safety and potential efficacy of the targeted mAb, Sipavibart (formerly AZD3152) in patients with Long COVID.

Conditions

Post-COVID / Long-COVID

Keywords

LongCOVID; Monoclonal antibody (mAb) therapy; Post-viral conditions

Outcome Measures

Primary Outcomes (2)

• Patient-Reported Outcomes Measurement Information System-29

  Comprehensive Symptom Burden Index (CSBI) total scores will serve as a composite outcome measure derived from eight PROMIS domains to capture overall symptom burden. Scores will be calculated at baseline and Week 12. Efficacy will be determined by the proportion of participants classified as IMPROVED, defined as having a ≥4.5-point increase in CSBI from baseline, a threshold representing moderate and clinically meaningful improvement.

  12 weeks

• Review of Treatment Related Adverse Events

  Number of participants with treatment-related adverse events as assessed by frequency of safety events during the study period.

  24 weeks

Secondary Outcomes (24)

• Symptom-specific participant-reported outcome measures

  24 weeks

• Change in Simple Reaction Time (Milliseconds)

  Baseline, 12 and 24 weeks

• Self-reported fatigue using MFI

  12 and 24 weeks

• Change in Heart Rate Post-6MWT

  12 and 24 weeks

• Processing Speed

  12 and 24 weeks

Study Arms (2)

Sipavibart

EXPERIMENTAL

Participants receive a single intramuscular dose of Sipavibart, 300 mg intramuscular and are then followed for a duration of six months.

Drug: Placebo

Placebo

PLACEBO COMPARATOR

Participants receive single dose of placebo (saline) indistinguishable from the active drug in appearance, and are then followed for a duration of six months.

Biological: Sipavibart

Interventions

Placebo DRUG

A single dose of placebo (saline) indistinguishable from the active drug in appearance

Sipavibart

Sipavibart BIOLOGICAL

A single intramuscular dose of Sipavibart, 300 mg

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 70 years old,
• Inciting event: Acute COVID documented by testing (PCR or antigen testing in a clinical setting).
• Onset of COVID symptoms occurring on or prior to August 31st, 2023; and persistence of symptomatic expression of Long COVID (defined #6 below) for more than 3 months after COVID diagnosis.
• Current symptomatic expression meets the case definition of ME/CFS.
• PROMIS 29 score at screening of moderate to severe (≥60).
• Meets National Academy of Sciences (NAS) criteria for Long COVID with the following provisions:
• Allowance for normal illnesses of aging, such as hypertension and diabetes, if the conditions are treated and are in demonstrable stable and acceptable ranges at the time of screening and assessment. Specifically, blood pressures \< 150 systolic and 90 diastolic mmHg are required.
• Allowance of stable comorbid conditions common in post viral illness, such as fibromyalgia, irritable bowel, interstitial cystitis, dysautonomia that have not required hospitalization in the two years prior to recruitment.
• Able to provide written consent to study. Agrees to participate in follow-up visits.

You may not qualify if:

• An individual is ineligible to participate if any of the following apply:
• Known active acute SARS-CoV-2 infection ≤ 4 weeks from consent.
• Known severe anemia, defined as \< 8 g/dL.
• Known stroke that resulted in cognitive impairment within 3 months of enrollment.
• Self-report of current treated or untreated major depression with psychotic or melancholic features, schizophrenia, bipolar disorder, delusional disorders, dementias of any type, or a history of CNS disorders that may affect cognitive function (i.e., epilepsy, stroke, brain tumor, multiple sclerosis, Parkinson's Disease, Alzheimer's disease), or substance abuse during the last two years, excluding cannabis products.
• Allergy to any ingredient of the study drug (self-report)
• Sipavibart is supplied as 150 mg/mL of active ingredient in 20 mM L-histidine/L-histidine hydrochloride, 220 mM L-arginine hydrochloride, and 0.04% (w/v) polysorbate 80, at pH 6.0.
• Hypersensitivity to other humanized mAbs.
• Current heavy alcohol or tobacco use (self-report). Alcohol consumption not to exceed approximately 15 drinks per week (with a drink defined as 12 oz beer, 5 oz wine, or 1.5 oz distilled spirits) and tobacco use not to exceed 20 cigarettes (or equivalent) per day during the last month.
• Active chronic infections such as HIV, Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV), indicated by self-report, and abnormal liver function tests (\>3x upper limit of normal) or evidence in the health record of chronic active hepatitis or human immunodeficiency virus (HIV).
• Renal disease (self-report; laboratory results: renal insufficiency with serum creatinine \> 2.0 mg/dL or eGFR \< 44; or currently on renal dialysis)
• Liver disease (self-report or laboratory results: hepatic insufficiency (bilirubin \>2.5mg/dL or transaminases \> 3X the upper limits of normal)
• Uncontrolled diabetes, evidenced by combination of morning blood glucose and previous diagnosis of diabetes, AIC\>7
• Diagnosed with congestive heart failure or significant arrythmia (ventricular tachycardia with a rapid rate at rest (\> 100 bpm), persistent atrial fibrillation, or second- or third-degree heart block)
• Pre-existing sustained severe hypertension (BP \>180/110 mmHg in the sitting position)

Sponsors & Collaborators

• Nancy Klimas: lead
• Florida Department of Health: collaborator

Study Sites (1)

Nova Southeastern University

Fort Lauderdale, Florida, 33314, United States

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Mycobacterium Infections, Nontuberculous

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; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Nancy Klimas, MD

  Nova Southeastern University

  PRINCIPAL INVESTIGATOR

• Amanpreet Cheema, PhD

  Nova Southeastern University

  STUDY DIRECTOR

Central Study Contacts

Nancy Klimas, MD

CONTACT

954-262-2286; nklimas@nova.edu

Alejandro Montealegre, MSN, ARNP

CONTACT

954-262-2286; am3841@nova.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Institute for Neuro Immune Medicine

Model Details: This placebo-controlled, randomized, blinded, two-arm phase II study will test the safety and potential efficacy of the targeted mAb, Sipavibart (formerly AZD3152) in 100 patients with Long COVID.

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: June 15, 2025
• Study Start: June 16, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-06

Locations

US (1)