Phase 2 Study of RSLV-132 in Subjects With Long COVID

NCT04944121 | Completed Phase 2 FDA Drug

• 1 other identifier: 132-05
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 5

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

Conditions

Post-acute Corona Virus 19 (COVID-19) (Long COVID)

Outcome Measures

Primary Outcomes (1)

• 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.

  From Baseline to Day 71

Secondary Outcomes (5)

• 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

Study Arms (2)

RSLV-132

EXPERIMENTAL

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

Drug: RSLV-132

Placebo

PLACEBO COMPARATOR

Sodium chloride 0.9% will be administered by intravenous infusion on Days: 1, 8, 15, 29, 43, and 57

Drug: Sodium Chloride 0.9%

Interventions

RSLV-132 DRUG

10 mg/kg RSLV-132 administered by intravenous infusion

RSLV-132

Sodium Chloride 0.9% DRUG

0.9% sodium chloride administered by intravenous infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• The presence of a clinically significant infection in the judgement of the Investigator, within seven days of Baseline
• Positive test for hepatitis B, C, or HIV at Screening
• Positive pregnancy test at Screening or Baseline
• Female subjects currently pregnant or breast feeding at Baseline
• Inability or unwillingness to comply with protocol-specified procedures which, in the opinion of the Investigator, would make the subject unsuitable for study participation

Sponsors & Collaborators

• Resolve Therapeutics: lead

Study Sites (5)

Resolve Clinical Center

Mobile, Alabama, 36608, United States

Location

Resolve Clinical Center

Coral Gables, Florida, 33134, United States

Location

Resolve Clinical Center

Pompano Beach, Florida, 33060, United States

Location

Resolve Clinical Center

Knoxville, Tennessee, 37920, United States

Location

Resolve Clinical Center

Seattle, Washington, 98103, United States

Location

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Interventions

RSLV-132; Sodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• James Posada

  Resolve Therapeutics LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: June 29, 2021
• Study Start: June 25, 2021
• Primary Completion: October 31, 2023
• Study Completion: November 30, 2023
• Last Updated: May 29, 2024

Record last verified: 2022-11

Locations

US (5)