Actively Recruiting
SARS-CoV-2 Specific Monoclonal Antibody for Post-COVID-19 Conditions (Long COVID)
Led by Nancy Klimas · Updated on 2025-08-05
100
Participants Needed
1
Research Sites
80 weeks
Total Duration
On this page
Sponsors
N
Nancy Klimas
Lead Sponsor
F
Florida Department of Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SARS-CoV-2 Specific Monoclonal Antibody for Post-COVID-19 Conditions (Long COVID)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Documented acute COVID-19 infection confirmed by PCR or antigen testing
- Onset of COVID symptoms on or before August 31, 2023, with Long COVID symptoms lasting more than 3 months after diagnosis
- Current symptoms meet the case definition of ME/CFS
- Moderate to severe symptom score of 60 or higher on PROMIS 29 at screening
- Meet National Academy of Sciences criteria for Long COVID, allowing stable common illnesses like treated hypertension (blood pressure below 150/90 mmHg) and diabetes
- Stable comorbid conditions common in post-viral illness, such as fibromyalgia, irritable bowel, interstitial cystitis, or dysautonomia, without hospitalization in the past 2 years
- Able to give written consent and willing to attend follow-up visits
You will not qualify if you...
- Active acute SARS-CoV-2 infection within 4 weeks of consent
- Severe anemia (hemoglobin less than 8 g/dL)
- Stroke causing cognitive impairment within 3 months before enrollment
- Current treated or untreated major psychiatric or central nervous system disorders affecting cognition
- Allergy to any ingredient in the study drug or hypersensitivity to similar monoclonal antibodies
- Heavy alcohol or tobacco use beyond specified limits in the last month
- Active chronic infections such as HIV, Hepatitis B or C, or abnormal liver function
- Renal disease with significant kidney impairment or on dialysis
- Liver disease with severe impairment
- Uncontrolled diabetes with high blood sugar levels
- Diagnosed congestive heart failure or serious heart rhythm problems
- Severe uncontrolled high blood pressure (above 180/110 mmHg)
- Recent serious heart or lung conditions within 4 weeks before consent
- Diagnosed bleeding disorders or use of blood-thinning medications
- Recent use of COVID antiviral medications within 30 days before screening
- Exclusionary diagnoses that can explain fatigue symptoms, including organ failure, chronic inflammatory diseases, major neurological diseases, systemic treatment diseases, major endocrine diseases, untreated sleep disorders, BMI over 40 kg/m2, temporary conditions like medication effects or untreated hypothyroidism
- Known chronic Lyme disease with ongoing symptoms
- Use of marijuana or illicit drugs within 30 days of consent
- Unable to stop symptomatic medications as required
- Moderate or severe immunocompromised status
- Scheduled or recent surgery within specified time frames
- Participation in other interventional clinical trials within 6 weeks before consent or planned during the study
- COVID vaccination within 90 days prior to study entry and during the study
- Pregnancy or positive pregnancy test for women of childbearing age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nova Southeastern University
Fort Lauderdale, Florida, United States, 33314
Actively Recruiting
Research Team
N
Nancy Klimas, MD
CONTACT
A
Alejandro Montealegre, MSN, ARNP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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