A Phase 2, Double-blind, Placebo-controlled Study of RSLV-132 in Subjects With Post-acute COVID-19 (Long COVID)
Overview
- Phase
- Phase 2
- Intervention
- RSLV-132
- Conditions
- Post-acute Corona Virus 19 (COVID-19) (Long COVID)
- Sponsor
- Resolve Therapeutics
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- PROMIS Fatigue SF 7a T-score
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
Detailed Description
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by qualitative Polymerase Chain Reaction (PCR) at least 24 weeks prior to Baseline
- •PROMIS Fatigue SF 7a raw score of 21 or greater at Screening (confirm onset of fatigue was post-infection)
- •Able to communicate and able to provide valid, written informed consent
- •Ages 18 to 75 inclusive
- •Minimum weight of 45 kg
- •Female participants shall be either of non-child-bearing potential (permanently sterilized by bilateral tubal occlusion, hysterectomy, or bilateral salpingectomy), or menopausal (more than one year since last menstrual cycle and confirmed by blood FSH levels \> 22 mIU/mL) OR practicing highly effective contraception (e.g., oral (but not including progestogen-only oral contraceptives), injectable, implantable or transdermal contraceptives, a non-hormonal intrauterine device \[IUD\] or an intrauterine hormone releasing system \[IUS\]) for at least 2 months prior to dosing and until 125 days after the last dose. In terms of sexual relations, female participants not practicing highly effective contraception as described above should abstain or only engage with male partners who are sterile or vasectomized. Female participants of child-bearing potential will also be required to have a negative serum pregnancy test \[beta human chorionic gonadotropin \[ß-hCG\]) at Screening and negative pregnancy urine test at Baseline. Female participants must agree not to donate eggs from the first dose until 125 days after the last dose
- •Male participants, who are not sterile or vasectomized, must agree to abstain or only engage with female partners who use highly effective contraception from the first dose until 125 days after the last dose. Male participants must also agree not to donate sperm from the first dose until 125 days after the last dose
Exclusion Criteria
- •Previous admission to the intensive care unit for COVID-19-related symptoms
- •Presence of orthostatic hypotension or tachycardia at Screening
- •Completion of COVID-19 vaccination less than 4 weeks of Baseline (i.e., 4 weeks after the second dose of a two-dose vaccine or 4 weeks after a single dose vaccine)
- •Use of therapies to treat COVID-19 symptoms such as remdesivir, dexamethasone (or any other corticosteroid), or convalescent plasma within 14 days of Baseline
- •Use of concomitant medications that are sedating
- •Screening lab abnormalities that may cause fatigue such as severe anemia or hypocalcaemia
- •History of anaphylaxis to a medication, diet, or environmental exposure such as bee sting
- •Previous diagnosis of chronic fatigue syndrome, fibromyalgia, lupus, Sjogren's syndrome, or postural orthostatic tachycardia syndrome (POTS)
- •Previous diagnosis of sleep apnea
- •Participation in another clinical study with receipt of an investigational product within 3 months or 5 half- lives, of last administration (whichever is longer) from Baseline
Arms & Interventions
RSLV-132
RSLV-132 is an enzymatically active ribonuclease designed to digest the ribonucleic acid contained in autoantibodies and immune complexes and thereby render them biologically inert. A dose of 10 mg/kg will be administered by intravenous infusion on Days: 1, 8, 15, 29, 43, and 57
Intervention: RSLV-132
Placebo
Sodium chloride 0.9% will be administered by intravenous infusion on Days: 1, 8, 15, 29, 43, and 57
Intervention: Sodium Chloride 0.9%
Outcomes
Primary Outcomes
PROMIS Fatigue SF 7a T-score
Time Frame: From Baseline to Day 71
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.
Secondary Outcomes
- FACIT Fatigue questionnaire(From Baseline to Day 71)
- Long COVID-19-related Symptom Assessment patient questionnaire(From Baseline to Day 71)
- Patient-reported Global Impression of Severity questionnaire(From Baseline to Day 71)
- Digit Symbol Substitution Test(From Baseline to Day 71)
- Physician Global Assessment(From Baseline to Day 71)