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

Part of paid clinical trials in Fort Lauderdale, Florida.

Sponsor
Nancy Klimas
Study ID
NCT07021794
Phase
PHASE2
Status
Recruiting
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Conditions

  • Post-COVID / Long-COVID

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    A single dose of placebo (saline) indistinguishable from the active drug in appearance
  • Sipavibart — BIOLOGICAL
    A single intramuscular dose of Sipavibart, 300 mg

Study Details

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.

Key Dates

Start date
Jun 16, 2025
Status verified
Jun 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sipavibart
    Participants receive a single intramuscular dose of Sipavibart, 300 mg intramuscular and are then followed for a duration of six months.
  • Placebo Comparator: Placebo
    Participants receive single dose of placebo (saline) indistinguishable from the active drug in appearance, and are then followed for a duration of six months.

Primary Outcome Measure

Patient-Reported Outcomes Measurement Information System-29 [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nova Southeastern UniversityFort LauderdaleFlorida33314
Melissa Faso, RN
[email protected]
954-262-2286
Fanny Collado, MSN, ARNP
[email protected]
Amanpreet Cheema, PhD (SUB_INVESTIGATOR)
Kristina Aenlle, PhD (SUB_INVESTIGATOR)
David Quesada, PhD (SUB_INVESTIGATOR)
Irma Rey, MD (SUB_INVESTIGATOR)

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Nova Southeastern University· Fort Lauderdale, FL