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Sipavibart for Long COVID

This study is testing a medication called Sipavibart to see if it can help people with Long COVID. Researchers want to find out if Sipavibart is safe and effective for improving Long COVID symptoms. You might be able to join if you are 18 to 70 years old, had a confirmed COVID-19 infection, and have had Long COVID symptoms for more than three months, with your initial COVID symptoms starting on or before August 31st, 2023. The study will look at how your symptoms change over 12 weeks and track any side effects for 24 weeks. The current recruitment status is unclear, but the study plans to enroll 100 participants.

Study design
This is a randomized, blinded study comparing Sipavibart to a placebo (an inactive substance). It is a two-arm study, meaning participants will receive either Sipavibart or the placebo. The study plans to enroll 100 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your symptoms will be tracked for 12 weeks, and any side effects will be monitored for 24 weeks after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07021794

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

Recruiting
PHASE2Ages 18–70InterventionalTreatment
Nancy Klimas
~100 participants
Updated 2025-08-05 on ClinicalTrials.gov
What's tested:PlaceboSipavibart

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient-Reported Outcomes Measurement Information System-29
Measured over 12 weeks
+1 more outcome measured

Conditions

Post-COVID / Long-COVID

Explore related trials

Post-Acute Sequelae of COVID-19

NCT07021794

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Nova Southeastern University

    Fort Lauderdale, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

Nancy Klimas, MD
[email protected]
954-262-2286
Email the study team

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Eligibility criteria

Exclusion

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.

What this trial measures

  • Patient-Reported Outcomes Measurement Information System-2912 weeks

    Comprehensive Symptom Burden Index (CSBI) total scores will serve as a composite outcome measure derived from eight PROMIS domains to capture overall symptom burden. Scores will be calculated at baseline and Week 12. Efficacy will be determined by the proportion of participants classified as IMPROVED, defined as having a ≥4.5-point increase in CSBI from baseline, a threshold representing moderate and clinically meaningful improvement.

  • Review of Treatment Related Adverse Events24 weeks

    Number of participants with treatment-related adverse events as assessed by frequency of safety events during the study period.