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Immunomodulator

RSLV-132 for Long COVID Syndrome

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
Awards & highlights

Study Summary

This trial is testing a new drug to see if it can help people with severe fatigue from COVID-19.

Eligible Conditions
  • Long COVID Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to day 71
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to day 71 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PROMIS Fatigue SF 7a T-score
Secondary outcome measures
Digit Symbol Substitution Test
FACIT Fatigue questionnaire
Long COVID-19-related Symptom Assessment patient questionnaire
+2 more

Side effects data

From 2019 Phase 2 trial • 28 Patients • NCT03247686
30%
Fatigue
25%
Arthralgia
25%
Upper respiratory tract infection
20%
Viral upper respiratory tract infection
15%
Headache
15%
Conjunctivitis
10%
Dizziness
10%
Rash
10%
Oropharyngeal pain
10%
Rash papular
10%
Dermatitis contact
10%
Muscle spasms
10%
Constipation
10%
Urinary tract infection
10%
Weight increased
10%
Cough
5%
Joint swelling
5%
Viral infection
5%
Oedema peripheral
5%
Sleep disorder
5%
Infusion related reaction
5%
Parotitis
5%
Palpitations
5%
Pain in extremity
5%
Diarrhoea
5%
Mouth ulceration
5%
Hordeolum
5%
Lower respiratory tract infection
5%
Joint injury
5%
Osteoarthritis
5%
Nausea
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
2016
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

Resolve TherapeuticsLead Sponsor
3 Previous Clinical Trials
124 Total Patients Enrolled
James PosadaStudy DirectorResolve Therapeutics LLC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the protocol for this study permit participants of 25 years or greater?

"Prospective participants of this study must be between 18 and 75 years old, as these are the established age boundaries."

Answered by AI

Are applications currently open for this research study?

"As indicated on clinicaltrials.gov, this particular medical study is not currently accepting patients; the trial was initially posted in June 2021 and most recently revised in November 2022. However, there are 1149 other studies that are still recruiting volunteers at present."

Answered by AI

How many individuals are engaged in this research endeavor?

"Unfortunately, this research project has concluded the recruitment of participants. Inception was on June 25th 2021 and the study's final update occurred on November 4th 2022. However, there are 1049 clinical trials that seek patients with atrial premature complexes and another 100 studies recruiting for RSLV-132 treatment options."

Answered by AI

To what conditions does RSLV-132 offer therapeutic relief?

"RSLV-132 is often utilized to manage diarrhea, yet it has also proven beneficial in alleviating inflammation of the nasal mucosa, general surgery procedures, and corneal edema."

Answered by AI

Has RSLV-132 received the blessing of the Food and Drug Administration?

"Our experts at Power rate RSLV-132's safety as a 2 due to the limited data confirming its efficacy and some supporting its safety."

Answered by AI

What qualifications must individuals meet in order to participate in this research?

"This clinical trial is enrolling 70 adults aged 18-75 with atrial premature complexes. Applicants must have laboratory-confirmed SARS-CoV-2 infection, be able to communicate and provide informed consent, weigh no less than 45 kgs, be non child bearing or menopausal for women and practice effective contraception for both genders. Additionally, female participants of childbearing potential will require a negative serum pregnancy test at screening and baseline while male participants that are not sterile need to abstain from sexual relations during the study period. Lastly applicants must also meet PROMIS fatigue SF 7a raw score criteria set as 21 or higher post infection"

Answered by AI

Is RSLV-132 a novel pharmaceutical that has been explored in recent studies?

"At present, 100 clinical trials are ongoing that involve the research of RSLV-132. Of these active studies, 25 have reached Phase 3. While its main focus is in Philadelphia, Pennsylvania, 385 locations worldwide are running investigations with this drug therapy."

Answered by AI

What is the core purpose of this scientific research?

"This clinical trial, to be assessed from Baseline till Day 71, chiefly aims to measure the PROMIS Fatigue SF 7a T-score. As secondary objectives, assessments of DePaul Post-exertional Malaise patient questionnaire and Profile of Fatigue's patient questionnaire at end of treatment vis a vis baseline will take place. Additionally, results of Patient-reported Outcomes Measurement Information System (PROMIS) Cognitive Function patient questionnaire are intended to be compared pre- and post-treatment as well."

Answered by AI
~19 spots leftby Apr 2025