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Sipavibart in Long COVID
NCT07021794Phase 2
Key facts
- Status
- Recruiting
- Start
- Jul 2025
- Primary completion
- Sep 2027
- Countries
- 1
- Modality
- Monoclonal Antibodies
- Drugs
- sipavibart
- Conditions
- post-COVID-19 condition (PCC)
01
Overview
Phase 2, randomised, double-blind trial in post-COVID-19 condition (PCC) comparing Sipavibart with Placebo (2 arms). Primary endpoints: Patient-Reported Outcomes Measurement Information System-29 at 12 weeks and Treatment Related Adverse Events at 24 weeks. Started Jul 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Sipavibart
Participants receive a single intramuscular dose of Sipavibart, 300 mg.
Placebo
Participants receive a single dose of placebo (saline).
03
Who it enrols
Adults 18-70 with Long COVID persisting >3 months, meeting ME/CFS criteria and PROMIS 29 >= 60. Excludes active COVID, severe anemia, recent stroke, severe psychiatric disorders, active chronic infections, renal/liver disease, uncontrolled diabetes, severe cardiovascular conditions, and recent COVID vaccination.
04
Endpoints
Primary
Patient-Reported Outcomes Measurement Information System-29
Treatment Related Adverse Events
Secondary
Symptom-specific participant-reported outcome measures
Change in Simple Reaction Time
Self-reported fatigue using Multidimensional Fatigue Inventory
Change in Heart Rate Post-6-Minute Walk Test
Processing Speed
Attention
Systolic Blood Pressure Response During NASA Lean Test
Diastolic Blood Pressure Response During NASA Lean Test
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