Effectiveness of Treating Post-COVID-19 Conditions (Long COVID) With the SARS-CoV-2 Specific Monoclonal Antibody, Sipavibart
Nancy Klimas
Summary
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.
Description
Acute COVID-19 infection can present differently among infected patients, with the infection ranging in symptom presentation from asymptomatic and mild symptomatology to severe illness. Common symptoms tied to a COVID-19 infection include fever, chills, cough, respiratory ailments (shortness of breath or difficulty breathing), fatigue, muscle and/or joint pain, headache, loss of taste or smell, sore throat, congestion, and/or gastrointestinal (GI) disturbances (nausea, vomiting, and/or diarrhea). In some patients, these symptoms are short-lived and span the length of the acute infection, while…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: An individual is eligible for inclusion if all of the following apply: 1. 18 to 70 years old, 2. Inciting event: Acute COVID documented by testing (PCR or antigen testing in a clinical setting). 3. 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. 4. Current symptomatic expression meets the case definition of ME/CFS. 5. PROMIS 29 score at screening of moderate to severe (≥60). 6. Meets National Academy of Sciences (NAS) criteria for Lo…
Interventions
- DrugPlacebo
A single dose of placebo (saline) indistinguishable from the active drug in appearance
- BiologicalSipavibart
A single intramuscular dose of Sipavibart, 300 mg
Location
- Nova Southeastern UniversityFort Lauderdale, Florida