The purpose of this study is to assess the efficacy (decrease in profound fatigue), safety and pharmacokinetics of RSLV-132 in subjects with long Corona Virus (COVID) syndome
This is a double-blind placebo-controlled study in approximately 70 subjects with long COVID syndrome. After being informed about the study and potential risks, all subjects giving written informed consent will be screened to determine eligibility in the 21 days before the start of study treatment. Prior to the first study treatment administration, subjects will be randomized in a 2:1 ratio to receive six administrations of 10 mg/kg RSLV-132 or placebo on Days 1, 8, 15, 29, 43 and 57. Subjects will then attend an end of study visit approximately 10 weeks after the start of treatment (Day 71).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
112
10 mg/kg RSLV-132 administered by intravenous infusion
0.9% sodium chloride administered by intravenous infusion
Resolve Clinical Center
Mobile, Alabama, United States
Resolve Clinical Center
Coral Gables, Florida, United States
Resolve Clinical Center
Pompano Beach, Florida, United States
Resolve Clinical Center
Knoxville, Tennessee, United States
PROMIS Fatigue SF 7a T-score
Mean change in Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS Fatigue 7a) T-score at the end of treatment compared to baseline. The PROMIS Fatigue 7a consists of seven questions measuring symptoms severity at five-point intervals, with higher scores representing a worse outcome.
Time frame: From Baseline to Day 71
FACIT Fatigue questionnaire
Comparison of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire at the end of treatment compared to baseline. The FACIT-F is a 13 item measure of fatigue with a 7 day recall memory. Items are scored on a five point scale (0-not at all to 4-very much). The total score therefore ranges from 0 to 52, with higher scores reflecting greater fatigue.
Time frame: From Baseline to Day 71
Long COVID-19-related Symptom Assessment patient questionnaire
Comparison of the Long COVID-19-related Symptom Assessment patient questionnaire at the end of treatment compared to baseline. Subjects will be asked to describe the severity of eight COVID-19 related symptoms (muscle pain, joint pain, chest pain, brain fog, chills, sweats, abdominal pain and chest tightness) over the last 7 days on a four point scale (0-none to 3-severe) with a higher score representing a worse outcome.
Time frame: From Baseline to Day 71
Patient-reported Global Impression of Severity questionnaire
Comparison of the Patient-reported Global Impression of Severity (PGIS) questionnaire at the end of treatment compared to baseline. Subjects will be asked to describe the severity of fatigue on the assessment day compared to the past 7 days on a four point scale (1-no improvement to 4-significant improvement) with a higher score representing a better outcome.
Time frame: From Baseline to Day 71
Digit Symbol Substitution Test
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Resolve Clinical Center
Seattle, Washington, United States
Comparison of the Digit Symbol Substitution Test (DSST) at the end of treatment compared to baseline. The DSST is a highly validated measure of the patient's ability to focus and concentrate of a simple task. Subjects with profound fatigue take more time to complete the test.
Time frame: From Baseline to Day 71
Physician Global Assessment
Comparison of the Physician Global Assessment at the end of treatment compared to baseline. The assessment is measured on a 0 to 100 mm scale with score 0 to be no disease activity and score 100 to be the most severe disease activity.
Time frame: From Baseline to Day 71