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New treatment option for Post-COVID / Long-COVID
Official title SARS-CoV-2 Specific Monoclonal Antibody for Post-COVID-19 Conditions (Long COVID)
ClinicalTrials.gov ID: NCT07021794
What this study is testing
What is Sipavibart?
Sipavibart is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for post-covid / long-covid.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- An individual is eligible for inclusion if all of the following apply:
- 18 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...
- Current symptomatic expression meets the case definition of ME/CFS.
You likely can't join 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...
- Allergy to any ingredient of the study drug (self-report)
See the full eligibility criteria
Who can join
- An individual is eligible for inclusion if all of the following apply:
- 18 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...
- 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...
- Able to provide written consent to study. Agrees to participate in follow-up visits. Subject
What rules you out
- 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...
- 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...
- 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...
- 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)
- Any of the following within 4 weeks of consent (Self-reported/medical record):
- an acute myocardial infarction or unstable angina
- uncontrolled arrhythmias causing symptoms or hemodynamic compromise
- acute myocarditis or pericarditis, uncontrolled acutely decompensated heart failure (acute pulmonary edema)
- acute pulmonary embolism
- suspected dissecting aneurysm
- severe hypoxemia at rest
- any acute or chronic disorder that may affect exercise performance, or
- if they are aggravated by exercise (e.g., infection, thyrotoxicosis, unable to cooperate)
- Diagnosed bleeding disorders or use of blood-thinning medications.
- Current or previous receipt of any COVID antiviral medication within 30 days prior to screening (self reported)
- 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...
- Organ failure
- Chronic inflammatory diseases
- Major neurologic diseases that could cause fatigue or neurologic deficits
- Diseases requiring systemic treatment (i.e., transplantation, chemotherapy, radiation)
- Major endocrine diseases
- Untreated primary sleep disorders
- BMI \> 40 kg/m2
- 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)
- Known diagnosis of chronic Lyme disease with persistent symptoms, sequelae, or related therapy.
- Any marijuana illicit drug use within 30 days of informed consent
- Inability to discontinue symptomatic medications for the identified time periods
- Moderate or severe immunocompromised patients, such as those described in the NIH COVID-Treatment Guidelines
- 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
- Participating in any treatment (including social-behavioral therapy) clinical trial of an investigational therapy within 6 weeks prior to consent, or planning to participate in another treatment clinical trial of an...
- COVID Vaccination within 90 days prior to entry and for the duration of the study
- Pregnancy is excluded. Women of childbearing age will be given a pregnancy test.
The study team makes the final eligibility decision.
Where it's taking place
- Fort Lauderdale, Florida, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fort Lauderdale, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.