Sipavibart for Long COVID Syndrome

(Monoclonal Trial)

Overseen By Alejandro Montealegre, MSN, ARNP

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Nancy Klimas

Must not be taking: Blood thinners, COVID antivirals

Disqualifiers: Severe anemia, Major depression, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks

100 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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

I tested positive for COVID-19 with a PCR or antigen test.

I am between 18 and 70 years old.

PROMIS 29 score at screening of moderate to severe (≥60)

Exclusion Criteria

I have not had an active COVID-19 infection in the last 4 weeks.

My immune system is significantly weakened.

I have been diagnosed with heart failure or irregular heartbeat.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intramuscular dose of Sipavibart or placebo and are then followed for a duration of six months

24 weeks

3 visits (in-person) at baseline, Week 12, and Week 24

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Open-label extension

Participants who continue to experience symptoms of Long COVID may receive one dose of Sipavibart in an open-label fashion

Long-term

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?

Group I: Sipavibart Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Nancy Klimas

Lead Sponsor

Florida Department of Health

Collaborator

Trials

30

Recruited

13,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07021794

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 ...

2. thelancet.com thelancet.com/journals/laninf/article/PIIS1473-3099(24)00804-1/fulltext

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 ...

3. cureus.com cureus.com/articles/421763-exploring-the-effects-of-pemivibart-monoclonal-antibody-infusion-in-long-covid-a-case-series-offering-initial-clinical-insights.pdf?email=

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 ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40015292/

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.

5. go.drugbank.com go.drugbank.com/conditions/DBCOND0140673

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 ...

6. go.drugbank.com go.drugbank.com/drugs/DB21908

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

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11493926/

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 ...

8. nature.com nature.com/articles/s41467-025-63972-4

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 ...