RECRUITING

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

Conditions

Post-COVID / Long-COVID LongCOVID Monoclonal antibody (mAb) therapy Post-viral conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effectiveness of Treating Post-COVID-19 Conditions (Long COVID) With the SARS-CoV-2 Specific Monoclonal Antibody, Sipavibart

Quick Facts

Study Start:2025-06-16

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07021794

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 18 to 70 years old, 2. Inciting event: Acute COVID documented by testing (PCR or antigen testing in a clinical setting). 3. 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. 4. Current symptomatic expression meets the case definition of ME/CFS. 5. PROMIS 29 score at screening of moderate to severe (≥60). 6. Meets National Academy of Sciences (NAS) criteria for Long COVID with the following provisions: 1. 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. 2. 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. 7. Able to provide written consent to study. Agrees to participate in follow-up visits. 1. Known active acute SARS-CoV-2 infection ≤ 4 weeks from consent. 2. Known severe anemia, defined as \< 8 g/dL. 3. Known stroke that resulted in cognitive impairment within 3 months of enrollment. 4. 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. 5. Allergy to any ingredient of the study drug (self-report) 1. 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. 2. Hypersensitivity to other humanized mAbs. 6. 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. 7. 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). 8. Renal disease (self-report; laboratory results: renal insufficiency with serum creatinine \> 2.0 mg/dL or eGFR \< 44; or currently on renal dialysis) 9. Liver disease (self-report or laboratory results: hepatic insufficiency (bilirubin \>2.5mg/dL or transaminases \> 3X the upper limits of normal) 10. Uncontrolled diabetes, evidenced by combination of morning blood glucose and previous diagnosis of diabetes, AIC\>7 11. 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) 12. Pre-existing sustained severe hypertension (BP \>180/110 mmHg in the sitting position) 13. Any of the following within 4 weeks of consent (Self-reported/medical record): 1. an acute myocardial infarction or unstable angina 2. uncontrolled arrhythmias causing symptoms or hemodynamic compromise 3. acute myocarditis or pericarditis, uncontrolled acutely decompensated heart failure (acute pulmonary edema) 4. acute pulmonary embolism 5. suspected dissecting aneurysm 6. severe hypoxemia at rest 7. any acute or chronic disorder that may affect exercise performance, or 8. if they are aggravated by exercise (e.g., infection, thyrotoxicosis, unable to cooperate) 14. Diagnosed bleeding disorders or use of blood-thinning medications. 15. Current or previous receipt of any COVID antiviral medication within 30 days prior to screening (self reported) 16. Currently have exclusionary diagnoses that could reasonably explain the symptoms of their fatiguing illness and their severity, using the exclusion criteria best described in the Ambiguities in case definition paper for CFS, as described in detail in \[13\] which clarifies exclusionary conditions. These exclusionary diagnoses that are not otherwise listed above comprise: 1. Organ failure 2. Chronic inflammatory diseases 3. Major neurologic diseases that could cause fatigue or neurologic deficits 4. Diseases requiring systemic treatment (i.e., transplantation, chemotherapy, radiation) 5. Major endocrine diseases 6. Untreated primary sleep disorders 7. BMI \> 40 kg/m2 8. Temporary conditions discovered at screening, such as * Temporary effects of medications * Temporary sleep deprivation * Untreated hypothyroidism, hypothyroidism that has been inadequately controlled during the last 3 months, or free T4 level not within normal limits * Active infection (for COVID-19 infection and other infections, participants may be rescreened six weeks after resolution of infection) 17. Known diagnosis of chronic Lyme disease with persistent symptoms, sequelae, or related therapy. 18. Any marijuana illicit drug use within 30 days of informed consent 19. Inability to discontinue symptomatic medications for the identified time periods 20. Moderate or severe immunocompromised patients, such as those described in the NIH COVID-Treatment Guidelines 21. Are scheduled for a surgery during the period of study participation, had minor surgery within three months prior to screening, or had major surgery within 6 months prior to screening 22. Participating in any interventional (including social-behavioral therapy) clinical trial of an investigational therapy within 6 weeks prior to consent, or planning to participate in another interventional clinical trial of an investigational therapy during the course of this study 23. COVID Vaccination within 90 days prior to entry and for the duration of the study 24. Pregnancy is excluded. Women of childbearing age will be given a pregnancy test.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

1. 18 to 70 years old,
2. Inciting event: Acute COVID documented by testing (PCR or antigen testing in a clinical setting).
3. 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.
4. Current symptomatic expression meets the case definition of ME/CFS.
5. PROMIS 29 score at screening of moderate to severe (≥60).
6. Meets National Academy of Sciences (NAS) criteria for Long COVID with the following provisions:
1. 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.
2. 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.
7. Able to provide written consent to study. Agrees to participate in follow-up visits.
1. Known active acute SARS-CoV-2 infection ≤ 4 weeks from consent.
2. Known severe anemia, defined as \< 8 g/dL.
3. Known stroke that resulted in cognitive impairment within 3 months of enrollment.
4. 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.
5. Allergy to any ingredient of the study drug (self-report)
1. 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.
2. Hypersensitivity to other humanized mAbs.
6. 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.
7. 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).
8. Renal disease (self-report; laboratory results: renal insufficiency with serum creatinine \> 2.0 mg/dL or eGFR \< 44; or currently on renal dialysis)
9. Liver disease (self-report or laboratory results: hepatic insufficiency (bilirubin \>2.5mg/dL or transaminases \> 3X the upper limits of normal)
10. Uncontrolled diabetes, evidenced by combination of morning blood glucose and previous diagnosis of diabetes, AIC\>7
11. 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)
12. Pre-existing sustained severe hypertension (BP \>180/110 mmHg in the sitting position)
13. Any of the following within 4 weeks of consent (Self-reported/medical record):
1. an acute myocardial infarction or unstable angina
2. uncontrolled arrhythmias causing symptoms or hemodynamic compromise
3. acute myocarditis or pericarditis, uncontrolled acutely decompensated heart failure (acute pulmonary edema)
4. acute pulmonary embolism
5. suspected dissecting aneurysm
6. severe hypoxemia at rest
7. any acute or chronic disorder that may affect exercise performance, or
8. if they are aggravated by exercise (e.g., infection, thyrotoxicosis, unable to cooperate)
14. Diagnosed bleeding disorders or use of blood-thinning medications.
15. Current or previous receipt of any COVID antiviral medication within 30 days prior to screening (self reported)
16. Currently have exclusionary diagnoses that could reasonably explain the symptoms of their fatiguing illness and their severity, using the exclusion criteria best described in the Ambiguities in case definition paper for CFS, as described in detail in \[13\] which clarifies exclusionary conditions. These exclusionary diagnoses that are not otherwise listed above comprise:
1. Organ failure
2. Chronic inflammatory diseases
3. Major neurologic diseases that could cause fatigue or neurologic deficits
4. Diseases requiring systemic treatment (i.e., transplantation, chemotherapy, radiation)
5. Major endocrine diseases
6. Untreated primary sleep disorders
7. BMI \> 40 kg/m2
8. Temporary conditions discovered at screening, such as
* Temporary effects of medications
* Temporary sleep deprivation
* Untreated hypothyroidism, hypothyroidism that has been inadequately controlled during the last 3 months, or free T4 level not within normal limits
* Active infection (for COVID-19 infection and other infections, participants may be rescreened six weeks after resolution of infection)
17. Known diagnosis of chronic Lyme disease with persistent symptoms, sequelae, or related therapy.
18. Any marijuana illicit drug use within 30 days of informed consent
19. Inability to discontinue symptomatic medications for the identified time periods
20. Moderate or severe immunocompromised patients, such as those described in the NIH COVID-Treatment Guidelines
21. Are scheduled for a surgery during the period of study participation, had minor surgery within three months prior to screening, or had major surgery within 6 months prior to screening
22. Participating in any interventional (including social-behavioral therapy) clinical trial of an investigational therapy within 6 weeks prior to consent, or planning to participate in another interventional clinical trial of an investigational therapy during the course of this study
23. COVID Vaccination within 90 days prior to entry and for the duration of the study
24. Pregnancy is excluded. Women of childbearing age will be given a pregnancy test.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Nancy Klimas, MD

CONTACT

954-262-2286

nklimas@nova.edu

Alejandro Montealegre, MSN, ARNP

CONTACT

954-262-2286

am3841@nova.edu

Principal Investigator

Nancy Klimas, MD

PRINCIPAL_INVESTIGATOR

Nova Southeastern University

Amanpreet Cheema, PhD

STUDY_DIRECTOR

Nova Southeastern University

Study Locations (Sites)

Nova Southeastern University

Fort Lauderdale, Florida, 33314

United States

Collaborators and Investigators

Sponsor: Nancy Klimas

Nancy Klimas, MD, PRINCIPAL_INVESTIGATOR, Nova Southeastern University
Amanpreet Cheema, PhD, STUDY_DIRECTOR, Nova Southeastern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-16

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-06-16

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

LongCOVID
Monoclonal antibody (mAb) therapy
Post-viral conditions

Additional Relevant MeSH Terms

Post-COVID / Long-COVID