Sipavibart for Long COVID Syndrome
(Monoclonal Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called Sipavibart to determine if it can improve symptoms in people with Long COVID. The study compares the effects of Sipavibart to a placebo (a look-alike treatment with no active ingredients) to assess its safety and effectiveness. It seeks participants who have experienced COVID symptoms since at least August 2023 and continue to face issues like chronic fatigue or other lingering symptoms. Participants should have stable health conditions, such as hypertension or diabetes, and agree to follow-up visits for six months. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important early findings.
Do I need to stop taking my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications, but it mentions that you must be able to discontinue symptomatic medications for certain time periods. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that Sipavibart is likely to be safe for humans?
Research shows that Sipavibart has been tested for safety in preventing COVID-19, particularly in individuals with weakened immune systems. This antibody works by blocking the virus. Sipavibart is already approved for use in these patients, indicating its well-established safety. Earlier studies found that this treatment was well-tolerated, with no major safety issues reported. Although this study focuses on Long COVID, the previous approval and research offer reassurance about its safety in humans.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about Sipavibart for Long COVID Syndrome because it offers a new approach compared to current treatment options, which typically focus on managing symptoms like fatigue and respiratory issues. Sipavibart is unique because it involves a single intramuscular dose, potentially simplifying the treatment process. Its distinct mechanism of action targets underlying factors of Long COVID, which could lead to more effective relief of symptoms over a six-month period. This innovative approach may provide a more targeted and efficient solution for those suffering from the lingering effects of COVID-19.
What evidence suggests that Sipavibart might be an effective treatment for Long COVID?
Research shows that Sipavibart, an anti-spike monoclonal antibody, may help treat COVID-19. Earlier studies found that Sipavibart lowers the risk of developing symptoms from COVID-19, suggesting it might also manage symptoms in Long COVID. In this trial, participants will receive either Sipavibart or a placebo to evaluate its effectiveness for Long COVID. Although researchers have mainly studied this treatment for preventing COVID-19, it might also alleviate ongoing symptoms in Long COVID by targeting the virus's spike protein. Early results from similar treatments have shown possible improvements in patients. However, more research is needed to confirm its effectiveness specifically for Long COVID symptoms.12678
Who Is on the Research Team?
Nancy Klimas, MD
Principal Investigator
Nova Southeastern University
Amanpreet Cheema, PhD
Principal Investigator
Nova Southeastern University
Are You a Good Fit for This Trial?
Adults aged 18-70 with Long COVID, as confirmed by past COVID tests and meeting specific criteria for symptom severity and duration. Participants must not have active SARS-CoV-2 infection or severe health conditions like heart failure, uncontrolled diabetes, or severe anemia. They should not be on blood thinners, heavy alcohol/tobacco users, pregnant, or have had recent vaccinations/surgeries.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intramuscular dose of Sipavibart or placebo and are then followed for a duration of six months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants who continue to experience symptoms of Long COVID may receive one dose of Sipavibart in an open-label fashion
What Are the Treatments Tested in This Trial?
Interventions
- Sipavibart
Trial Overview
The trial is testing Sipavibart (a monoclonal antibody) against a placebo to see if it's safe and can help with Long COVID symptoms. It's a phase II study where participants are randomly assigned to receive either the real drug or a fake one without knowing which they're getting.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants receive a single intramuscular dose of Sipavibart, 300 mg intramuscular and are then followed for a duration of six months.
Participants receive single dose of placebo (saline) indistinguishable from the active drug in appearance, and are then followed for a duration of six months.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nancy Klimas
Lead Sponsor
Florida Department of Health
Collaborator
Citations
SARS-CoV-2 Specific Monoclonal Antibody for Post- ...
This study will employ a two-arm randomized design to evaluate the efficacy of the drug Sipavibart in individuals experiencing LC symptoms. Participants will ...
Efficacy and safety of sipavibart for prevention of COVID-19 ...
The primary results of this trial show that sipavibart, an anti-spike monoclonal antibody, moderately reduced the risk of symptomatic COVID-19 ...
Exploring the Effects of Pemivibart Monoclonal Antibody ...
In this context, we present a case series describing clinical characteristics, treatment course, and patient- reported outcomes following ...
Efficacy and safety of sipavibart for prevention of COVID-19 ...
This trial assessed sipavibart efficacy and safety for prevention of symptomatic COVID-19 in participants who are immunocompromised.
Post-Acute COVID-19 Syndrome (DBCOND0140673)
Investigating Measurable PRO Acuity Trial (IMPACT) is a Multi-Center Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Maraviroc ...
Sipavibart: Uses, Interactions, Mechanism of Action
Sipavibart is approved for the pre-exposure prophylaxis treatment of COVID-19 in immunocompromised patients. Modality: Protein Based Therapies
Post-acute sequelae of SARS-CoV-2 infection (Long COVID ...
Long COVID, also known as PASC (post-acute sequelae of SARS-CoV-2), is a complex infection-associated chronic condition affecting tens of millions of people ...
A SARS-CoV-2 variant‑adjusted threshold of protection ...
Efficacy and safety of sipavibart for prevention of COVID-19 in individuals who are immunocompromised (SUPERNOVA): a randomised, controlled ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.