Fort Lauderdale, FLNCT07021794Now EnrollingIRB Ready

Post-COVID / Long-COVID Clinical Trial in Fort Lauderdale, FL

Access cutting-edge post-covid / long-covid treatment through this phase 2 clinical trial at a research site in Fort Lauderdale. Study-provided care at no cost to qualified participants.

Sponsored by Nancy Klimas

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Expert Care in Fort Lauderdale

Access post-covid / long-covid specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related post-covid / long-covid treatment provided free

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Check if you qualify for this post-covid / long-covid clinical trial in Fort Lauderdale, FL

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Fort Lauderdale

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Fort Lauderdale site if eligible
  4. 4Begin participation

About This Post-COVID / Long-COVID Study in Fort Lauderdale

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.

Sponsor: Nancy Klimas

Who Can Participate

Inclusion Criteria

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 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. Subject

Exclusion Criteria

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)
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 CFS, as described in detail in \[13\] which clarifies exclusionary conditions. These exclusionary diagnoses that are not otherwise listed above comprise:
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 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
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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Fort Lauderdale?

Yes, this clinical trial (NCT07021794) has an active research site in Fort Lauderdale, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Post-COVID / Long-COVID Treatment Options in Fort Lauderdale, FL

If you're searching for post-covid / long-covid treatment options in Fort Lauderdale, FL, this clinical trial (NCT07021794) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Fort Lauderdale research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced post-covid / long-covid specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all post-covid / long-covid clinical trials near you to find additional studies recruiting in your area.

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