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Immunomodulator
Phase 2 Study of RSLV-132 in Subjects With Long COVID
Phase 2
Waitlist Available
Research Sponsored by Resolve Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to day 71
Summary
This trial is testing a drug called RSLV-132 to see if it can help reduce severe tiredness in people with long COVID syndrome. The study involves people who still feel very tired after recovering from COVID-19. The drug might work by helping the body handle the long-term effects of the virus.
Eligible Conditions
- Long COVID Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to day 71
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to day 71
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
PROMIS Fatigue SF 7a T-score
Secondary study objectives
Digit Symbol Substitution Test
FACIT Fatigue questionnaire
Long COVID-19-related Symptom Assessment patient questionnaire
+2 moreSide effects data
From 2019 Phase 2 trial • 28 Patients • NCT0324768630%
Fatigue
25%
Arthralgia
25%
Upper respiratory tract infection
20%
Viral upper respiratory tract infection
15%
Conjunctivitis
15%
Headache
10%
Urinary tract infection
10%
Muscle spasms
10%
Dermatitis contact
10%
Dizziness
10%
Rash
10%
Oropharyngeal pain
10%
Rash papular
10%
Weight increased
10%
Constipation
10%
Cough
5%
Hordeolum
5%
Joint injury
5%
Pain in extremity
5%
Joint swelling
5%
Nausea
5%
Osteoarthritis
5%
Lower respiratory tract infection
5%
Infusion related reaction
5%
Oedema peripheral
5%
Parotitis
5%
Palpitations
5%
Diarrhoea
5%
Mouth ulceration
5%
Viral infection
5%
Sleep disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
RSLV-132
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RSLV-132Experimental Treatment1 Intervention
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
Group II: PlaceboPlacebo Group1 Intervention
Sodium chloride 0.9% will be administered by intravenous infusion on Days: 1, 8, 15, 29, 43, and 57
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RSLV-132
2021
Completed Phase 2
~240
Find a Location
Who is running the clinical trial?
Resolve TherapeuticsLead Sponsor
4 Previous Clinical Trials
230 Total Patients Enrolled
James PosadaStudy DirectorResolve Therapeutics LLC
1 Previous Clinical Trials
106 Total Patients Enrolled