Effectiveness of Treating Post-COVID-19 Conditions (Long COVID) With the SARS-CoV-2 Specific Monoclonal Antibody, Sipavibart
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.
∙ An individual is eligible for inclusion if all of the following apply:
• 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.
• PROMIS 29 score at screening of moderate to severe (≥60).
• Meets National Academy of Sciences (NAS) criteria for Long COVID with the following provisions:
‣ Allowance for normal illnesses of aging, such as hypertension and diabetes, if the conditions are treated and are in demonstrable stable and acceptable ranges at the time of screening and assessment. Specifically, blood pressures \< 150 systolic and 90 diastolic mmHg are required.
⁃ Allowance of stable comorbid conditions common in post viral illness, such as fibromyalgia, irritable bowel, interstitial cystitis, dysautonomia that have not required hospitalization in the two years prior to recruitment.
• Able to provide written consent to study. Agrees to participate in follow-up visits.