SARS-CoV-2 Specific Monoclonal Antibody for Post-COVID-19 Conditions (Long COVID)
ConditionPost-COVID / Long-COVID
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNancy Klimas
About this trial
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.
Eligibility criteria
Qualifiers
18 to 70 years old,
Inciting event: Acute COVID documented by testing (PCR or antigen testing in a clinical setting).
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.
Current symptomatic expression meets the case definition of ME/CFS.
Disqualifiers
Known active acute SARS-CoV-2 infection ≤ 4 weeks from consent.
Known severe anemia, defined as < 8 g/dL.
Known stroke that resulted in cognitive impairment within 3 months of enrollment.
Self-report of current treated or untreated major depression with psychotic or melancholic features, schizophrenia, bipolar disorder, delusional disorders, dementias of any type, or a history of CNS disorders that may affect cognitive function (i.e., epilepsy, stroke, brain tumor, multiple sclerosis, Parkinson's Disease, Alzheimer's disease), or substance abuse during the last two years, excluding cannabis products.
Trial design
Treatments tested in this trial
- Placebo
- Sipavibart
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Nancy Klimas
Lead sponsor
Nova Southeastern University
Sponsor institution
Florida Department of Health
Collaborator
Source ClinicalTrials.gov