Acute Lung InjuryPhase 1NCT04574869
A Study of RLS-0071 in Patients With Acute Lung Injury Due to COVID-19 Pneumonia in Early Respiratory Failure
A Phase 1 study testing RLS-0071 10 mg/kg and RLS-0071 40 mg/kg in people with Acute Lung Injury and ALI, run by ReAlta Life Sciences, Inc. at 1 site in United States.
Trial summary
The aim of this study will test the safety, tolerability, and efficacy of RLS-0071 for approximately 28 days in comparison to a placebo control in patients with acute lung injury due to COVID-19 pneumonia in early respiratory failure. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Acute Lung Injury, ALI, COVID-19
- What is being tested?
- RLS-0071 10 mg/kg and RLS-0071 40 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2021to Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed COVID-19 based on positive SARS-CoV-2 viral RNA PCR or antigen test.
- Hypoxemia.
- Radiographic evidence of opacification consistent with viral-related pneumonia.
- Weight less than 150 kg.
- Provide written informed consent.
Who cannot join
- Endotracheal intubation and mechanical ventilation.
- Noninvasive positive pressure ventilation without endotracheal intubation.
- Requires chronic oxygen therapy.
- Treatment with conventional synthetic disease-modifying antirheumatic drugs (DMARDs)/immunosuppressive agents for ≥ 4 weeks duration within 3 months prior to the Screening visit.
- Use of oral corticosteroids in a dose higher than prednisone 15 mg or equivalent per day for ≥ 4 weeks duration within 3 months prior to the Screening visit.
- Systemic autoimmune disease.
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- Participation in any clinical research study evaluating an investigational product or therapy within 3 months prior to the Screening visit,
- Presence of any of the following abnormal laboratory values at Screening: absolute neutrophil count < 2,000/mm3, aspartate aminotransferase or alanine aminotransferase > 5 × upper limit of normal (ULN), platelets < 50,000/mm3.
- D-dimer > 2 × ULN at Screening, as evidence of potential disseminated intravascular coagulation (DIC).
- Has confounding medical conditions, including poorly controlled diabetes, uncontrolled New York Heart Association Class III congestive heart failure, clinically significant arrhythmias not controlled by medication, idiopathic pulmonary fibrosis, interstitial lung disease, or chronic obstructive pulmonary disease.
- Has bacterial sepsis currently or suspicion thereof.
- Has cancer currently and is receiving active treatment (including radiation therapy or chemotherapy) or malignancy within the last 5 years, with the exception of curable cancer (eg, basal or squamous cell skin cancer, cervical cancer in situ, nonmedullary thyroid carcinoma) that has been adequately treated (eg, excision).
- Prior history of myocardial infarction or angina, stroke or transient ischemic attack (TIA), pulmonary embolism or deep vein thrombosis.
- Is moribund and not expected to survive 48 hours following Screening or for whom no further aggressive treatment such as mechanical ventilation is planned.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Two-Part Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, PK, & PD of RLS-0071 in Patients With Acute Lung Injury Due to COVID-19 Pneumonia in Early Respiratory Failure
The aim of this study will test the safety, tolerability, and efficacy of RLS-0071 for approximately 28 days in comparison to a placebo control in patients with acute lung injury due to COVID-19 pneumonia in early respiratory failure.
Patients will be randomized and double-blinded for two parts, a single-ascending dose (SAD) part and a multiple-ascending dose (MAD) part.
The name of the study drug involved in this study is: RLS-0071.
- Conditions
- Acute Lung Injury, ALI, COVID-19
- Being tested
- RLS-0071 10 mg/kg, RLS-0071 40 mg/kg, Placebo
- Keywords
- Acute Lung Injury, Sars-CoV2, COVID-19, COVID-19 pneumonia, Early Respiratory Failure, ALI
- Medical subject headings
- Acute Lung Injury, COVID-19, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RLS-0071 10 mg/kgDrug
Single dose IV infusion of 10 mg/kg RLS-0071
RLS-0071 40 mg/kgDrug
Single dose IV infusion of 40 mg/kg RLS-0071
PlaceboDrug
The placebo control will be commercial sterile saline (0.9% Sodium Chloride Injection, United States Pharmacopoeia [USP]).
RLS-0071 10 mg/kgDrug
Multiple dose IV infusion of 10 mg/kg RLS-0071 administered every 8 hours for approximately 3 days (9 consecutive doses)
RLS-0071 40 mg/kgDrug
Multiple dose IV infusion of 40 mg/kg RLS-0071 administered every 8 hours for approximately 3 days (9 consecutive doses)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Not described Receives: Drug: RLS-0071 10 mg/kg; Drug: Placebo |
| Cohort 2 | Experimental | Not described Receives: Drug: RLS-0071 40 mg/kg; Drug: Placebo |
| Placebo Cohorts 1 and 2 | Placebo comparator | Placebo will be administered at the same volume and duration of IV infusion corresponding to the cohort dosing schedule. Receives: Drug: Placebo |
| Cohort 3 | Experimental | Not described Receives: Drug: Placebo; Drug: RLS-0071 10 mg/kg |
| Cohort 4 | Experimental | Not described Receives: Drug: Placebo; Drug: RLS-0071 40 mg/kg |
| Placebo Cohorts 3 and 4 | Placebo comparator | Placebo will be administered at the same volume and duration of IV infusion corresponding to the cohort dosing schedule. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of Adverse Events, including Serious Adverse Events, by treatment group and dose level, including the frequency of premature discontinuation of study intervention due to Adverse Events.
Measured: Through study completion at Day 28 following last dose.
Secondary outcomes (30)
Incidence of clinically significant changes from baseline in clinical laboratory values, ADA, autoantibody panel, vital signs, physical examination, ECG, radiography, and concomitant medications.
Measured: Through study completion at Day 28 following last dose; (if positive ADA/antibodies, Day 90 and Day 180 following last dose).
Number of patients with positive ADA titers after receiving a single dose (Part A) or multiple doses (Part B) of RLS-0071.
Measured: Through study completion at Day 28 following last dose; (if positive ADA/antibodies, Day 90 and Day 180 following last dose).
Estimates of single-dose maximum plasma concentration (Cmax) for RLS-0071.
Measured: Pre-Dose (within 30 minutes before start of dosing), 5 and 30 minutes after start of dosing, and 1, 2, 3, 4, 5, 6, 7, 8,12, 18, 24, 36, and 48 hours after the start of dosing, up to 28 days following last dose.
Estimates of single-dose time to maximum plasma concentration (Tmax) for RLS-0071.
Measured: Pre-Dose (within 30 minutes before start of dosing), 5 and 30 minutes after start of dosing, and 1, 2, 3, 4, 5, 6, 7, 8,12, 18, 24, 36, and 48 hours after the start of dosing, up to 28 days following last dose.
Estimates of single-dose minimum plasma concentration (Cmin) for RLS-0071.
Measured: Pre-Dose (within 30 minutes before start of dosing), 5 and 30 minutes after start of dosing, and 1, 2, 3, 4, 5, 6, 7, 8,12, 18, 24, 36, and 48 hours after the start of dosing, up to 28 days following last dose.
Estimates of single-dose area under the plasma concentration-time curve (AUC) for RLS-0071.
Measured: Pre-Dose (within 30 minutes before start of dosing), 5 and 30 minutes after start of dosing, and 1, 2, 3, 4, 5, 6, 7, 8,12, 18, 24, 36, and 48 hours after the start of dosing, up to 28 days following last dose.
Estimates of single-dose apparent total volume of distribution for RLS-0071.
Measured: Pre-Dose (within 30 minutes before start of dosing), 5 and 30 minutes after start of dosing, and 1, 2, 3, 4, 5, 6, 7, 8,12, 18, 24, 36, and 48 hours after the start of dosing, up to 28 days following last dose.
Estimates of single-dose apparent total body clearance for RLS-0071.
Measured: Pre-Dose (within 30 minutes before start of dosing), 5 and 30 minutes after start of dosing, and 1, 2, 3, 4, 5, 6, 7, 8,12, 18, 24, 36, and 48 hours after the start of dosing, up to 28 days following last dose.
Estimates of single-dose apparent first-order terminal elimination half-life for RLS-0071.
Measured: Pre-Dose (within 30 minutes before start of dosing); 30 minutes after the start of dosing; and 1, 2, 4, 6, 12, 18, 24, 36, and 48 hours after the start of dosing. The last PK sample will be taken 48 hours following the last dosing (the 9th infusion
Estimates of multiple-dose maximum plasma concentration (Cmax) for RLS-0071.
Measured: Pre-Dose (within 30 minutes before start of dosing); 30 minutes after the start of dosing; and 1, 2, 4, 6, 12, 18, 24, 36, and 48 hours after the start of dosing. The last PK sample will be taken 48 hours following the last dosing (the 9th infusion).
Estimates of multiple-dose peak time to maximum plasma concentration (Tmax) for RLS-0071.
Measured: Pre-Dose (within 30 minutes before start of dosing); 30 minutes after the start of dosing; and 1, 2, 4, 6, 12, 18, 24, 36, and 48 hours after the start of dosing. The last PK sample will be taken 48 hours following the last dosing (the 9th infusion).
Estimates of multiple-dose area under the plasma concentration-time curve (AUC) for RLS-0071.
Measured: Pre-Dose (within 30 minutes before start of dosing); 30 minutes after the start of dosing; and 1, 2, 4, 6, 12, 18, 24, 36, and 48 hours after the start of dosing. The last PK sample will be taken 48 hours following the last dosing (the 9th infusion).
Estimates of multiple-dose average plasma drug concentration observed (Cavg) for RLS-0071.
Measured: Pre-Dose (within 30 minutes before start of dosing); 30 minutes after the start of dosing; and 1, 2, 4, 6, 12, 18, 24, 36, and 48 hours after the start of dosing. The last PK sample will be taken 48 hours following the last dosing (the 9th infusion).
Estimates of multiple-dose trough concentration prior to dose administration (Ctrough).
Measured: Pre-Dose (within 30 minutes before start of dosing); 30 minutes after the start of dosing; and 1, 2, 4, 6, 12, 18, 24, 36, and 48 hours after the start of dosing. The last PK sample will be taken 48 hours following the last dosing (the 9th infusion).
Estimates of multiple-dose apparent total volume of distribution for RLS-0071.
Measured: Pre-Dose (within 30 minutes before start of dosing); 30 minutes after the start of dosing; and 1, 2, 4, 6, 12, 18, 24, 36, and 48 hours after the start of dosing. The last PK sample will be taken 48 hours following the last dosing (the 9th infusion).
Estimates of multiple-dose apparent first-order terminal elimination half-life for RLS-0071.
Measured: Pre-Dose (within 30 minutes before start of dosing); 30 minutes after the start of dosing; and 1, 2, 4, 6, 12, 18, 24, 36, and 48 hours after the start of dosing. The last PK sample will be taken 48 hours following the last dosing (the 9th infusion).
Assessment of dose response relationship of single and multiple doses of RLS-0071 on C1q levels and the complement activity assay.
Measured: Through study completion at Day 28 following last dose.
Overall survival.
Measured: Through Day 15 and through study completion at Day 28 following last dose.
Incidence of progression to respiratory failure requiring mechanical ventilation.
Measured: Days on ventilation while in the hospital through study completion at Day 28.
Incidence of transfer to the ICU.
Measured: Through Day 15 following last dose; through study completion at Day 28 following last dose; and duration of ICU stay days in the hospital post-dose through study completion at Day 28.
Duration of hospitalization after treatment (days).
Measured: Through study completion at Day 28 following last dose.
Incidence, severity, and duration after treatment (days) of fever (≥ 39.0°C).
Measured: Through study completion at Day 28 following last dose.
Incidence, severity, and duration after treatment (days) of cough per investigator assessment of CTCAE's latest version.
Measured: Through study completion at Day 28 following last dose.
Duration of requirement for supplemental oxygen after treatment (days).
Measured: Through study completion at Day 28 following last dose.
PaO2/FiO2
Measured: Through study completion at Day 28 following last dose.
Incidence, severity, and duration after treatment (days) of new cardiovascular events as assessed by the investigator (e.g. myocardial infarction, stroke, TIA, ischemic limb) with CTCAE's latest version.
Measured: Through Day 15 and through study completion at Day 28 following last dose.
Incidence, severity, and duration after treatment (days) of respiratory acidosis as assessed by the investigator with CTCAE's latest version.
Measured: Through Day 15 and through study completion at Day 28 following last dose.
Incidence and duration after treatment (days) of dialysis.
Dialysis will be assessed by the investigator with CTCAE's latest version.
Measured: Through Day 15 and through study completion at Day 28 following last dose.
Levels of complement activity (eg, CH50).
Measured: Through study completion at Day 28 following last dose.
Levels of C1q (free and bound to RLS-0071).
Measured: Through study completion at Day 28 following last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study startJan 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Low probability of enrolling patients prior to expiry of study drug.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Study intervention, RLS-0071 or placebo, will be administered as an IV infusion over 30 minutes (± 10 minutes). The following dose groups are planned: Part A (Single-Ascending Dose): * Cohort 1: low dose (single infusion) vs. placebo * Cohort 2: high dose (single infusion) vs. placebo Part B (Multiple-Ascending Dose): * Cohort 3: low dose administered q8 hours (± 1 hour) vs. placebo for 3 days (9 doses) * Cohort 4: high dose administered q8 hours (± 1 hour) vs. placebo for 3 days (9 doses)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ReAlta Life Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenji Cunnion, MD, MPH, Study chair, ReAlta Life Sciences, Inc.Linda Dell, Study director, ReAlta Life Sciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574869
- Sponsor's protocol ID
- RLS-0071-102
- Status last verified
- Jan 2022
- First submitted
- 16 Sep 2020
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Two-Part Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, PK, & PD of RLS-0071 in Patients With Acute Lung Injury Due to COVID-19 Pneumonia in Early Respiratory Failure
- ClinicalTrials.gov ID
- NCT04574869
- Acronym / sponsor ID
- RLS-0071-102
- Conditions
- Acute Lung Injury, ALI, COVID-19
- Keywords
- Acute Lung Injury, Sars-CoV2, COVID-19, COVID-19 pneumonia, Early Respiratory Failure, ALI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Low probability of enrolling patients prior to expiry of study drug.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ReAlta Life Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study will test the safety, tolerability, and efficacy of RLS-0071 for approximately 28 days in comparison to a placebo control in patients with acute lung injury due to COVID-19 pneumonia in early respiratory failure.
Patients will be randomized and double-blinded for two parts, a single-ascending dose (SAD) part and a multiple-ascending dose (MAD) part.
The name of the study drug involved in this study is: RLS-0071.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- Study intervention, RLS-0071 or placebo, will be administered as an IV infusion over 30 minutes (± 10 minutes). The following dose groups are planned: Part A (Single-Ascending Dose): * Cohort 1: low dose (single infusion) vs. placebo * Cohort 2: high dose (single infusion) vs. placebo Part B (Multiple-Ascending Dose): * Cohort 3: low dose administered q8 hours (± 1 hour) vs. placebo for 3 days (9 doses) * Cohort 4: high dose administered q8 hours (± 1 hour) vs. placebo for 3 days (9 doses)
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: RLS-0071 10 mg/kg, Drug: Placebo |
| Cohort 2 | Experimental | Drug: RLS-0071 40 mg/kg, Drug: Placebo |
| Placebo Cohorts 1 and 2 | Placebo comparator | Drug: PlaceboPlacebo will be administered at the same volume and duration of IV infusion corresponding to the cohort dosing schedule. |
| Cohort 3 | Experimental | Drug: Placebo, Drug: RLS-0071 10 mg/kg |
| Cohort 4 | Experimental | Drug: Placebo, Drug: RLS-0071 40 mg/kg |
| Placebo Cohorts 3 and 4 | Placebo comparator | Drug: PlaceboPlacebo will be administered at the same volume and duration of IV infusion corresponding to the cohort dosing schedule. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed COVID-19 based on positive SARS-CoV-2 viral RNA PCR or antigen test.
- Hypoxemia.
- Radiographic evidence of opacification consistent with viral-related pneumonia.
- Weight less than 150 kg.
- Provide written informed consent.
Key exclusion criteria (14 listed)
- Endotracheal intubation and mechanical ventilation.
- Noninvasive positive pressure ventilation without endotracheal intubation.
- Requires chronic oxygen therapy.
- Treatment with conventional synthetic disease-modifying antirheumatic drugs (DMARDs)/immunosuppressive agents for ≥ 4 weeks duration within 3 months prior to the Screening visit.
- Use of oral corticosteroids in a dose higher than prednisone 15 mg or equivalent per day for ≥ 4 weeks duration within 3 months prior to the Screening visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RLS-0071 10 mg/kgSingle dose IV infusion of 10 mg/kg RLS-0071 | Drug | Cohort 1 |
| RLS-0071 40 mg/kgSingle dose IV infusion of 40 mg/kg RLS-0071 | Drug | Cohort 2 |
| PlaceboThe placebo control will be commercial sterile saline (0.9% Sodium Chloride Injection, United States Pharmacopoeia [USP]). | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Placebo Cohorts 1 and 2, Placebo Cohorts 3 and 4 |
| RLS-0071 10 mg/kgMultiple dose IV infusion of 10 mg/kg RLS-0071 administered every 8 hours for approximately 3 days (9 consecutive doses) | Drug | Cohort 3 |
| RLS-0071 40 mg/kgMultiple dose IV infusion of 40 mg/kg RLS-0071 administered every 8 hours for approximately 3 days (9 consecutive doses) | Drug | Cohort 4 |
Primary outcome
Frequency and severity of Adverse Events, including Serious Adverse Events, by treatment group and dose level, including the frequency of premature discontinuation of study intervention due to Adverse Events.
Time frame: Through study completion at Day 28 following last dose.
30 secondary outcomes
Incidence of clinically significant changes from baseline in clinical laboratory values, ADA, autoantibody panel, vital signs, physical examination, ECG, radiography, and concomitant medications.
Time frame: Through study completion at Day 28 following last dose; (if positive ADA/antibodies, Day 90 and Day 180 following last dose).
Number of patients with positive ADA titers after receiving a single dose (Part A) or multiple doses (Part B) of RLS-0071.
Time frame: Through study completion at Day 28 following last dose; (if positive ADA/antibodies, Day 90 and Day 180 following last dose).
Estimates of single-dose maximum plasma concentration (Cmax) for RLS-0071.
Time frame: Pre-Dose (within 30 minutes before start of dosing), 5 and 30 minutes after start of dosing, and 1, 2, 3, 4, 5, 6, 7, 8,12, 18, 24, 36, and 48 hours after the start of dosing, up to 28 days following last dose.
Estimates of single-dose time to maximum plasma concentration (Tmax) for RLS-0071.
Time frame: Pre-Dose (within 30 minutes before start of dosing), 5 and 30 minutes after start of dosing, and 1, 2, 3, 4, 5, 6, 7, 8,12, 18, 24, 36, and 48 hours after the start of dosing, up to 28 days following last dose.
Estimates of single-dose minimum plasma concentration (Cmin) for RLS-0071.
Time frame: Pre-Dose (within 30 minutes before start of dosing), 5 and 30 minutes after start of dosing, and 1, 2, 3, 4, 5, 6, 7, 8,12, 18, 24, 36, and 48 hours after the start of dosing, up to 28 days following last dose.
Estimates of single-dose area under the plasma concentration-time curve (AUC) for RLS-0071.
Time frame: Pre-Dose (within 30 minutes before start of dosing), 5 and 30 minutes after start of dosing, and 1, 2, 3, 4, 5, 6, 7, 8,12, 18, 24, 36, and 48 hours after the start of dosing, up to 28 days following last dose.
Estimates of single-dose apparent total volume of distribution for RLS-0071.
Time frame: Pre-Dose (within 30 minutes before start of dosing), 5 and 30 minutes after start of dosing, and 1, 2, 3, 4, 5, 6, 7, 8,12, 18, 24, 36, and 48 hours after the start of dosing, up to 28 days following last dose.
Estimates of single-dose apparent total body clearance for RLS-0071.
Time frame: Pre-Dose (within 30 minutes before start of dosing), 5 and 30 minutes after start of dosing, and 1, 2, 3, 4, 5, 6, 7, 8,12, 18, 24, 36, and 48 hours after the start of dosing, up to 28 days following last dose.
Estimates of single-dose apparent first-order terminal elimination half-life for RLS-0071.
Time frame: Pre-Dose (within 30 minutes before start of dosing); 30 minutes after the start of dosing; and 1, 2, 4, 6, 12, 18, 24, 36, and 48 hours after the start of dosing. The last PK sample will be taken 48 hours following the last dosing (the 9th infusion
Estimates of multiple-dose maximum plasma concentration (Cmax) for RLS-0071.
Time frame: Pre-Dose (within 30 minutes before start of dosing); 30 minutes after the start of dosing; and 1, 2, 4, 6, 12, 18, 24, 36, and 48 hours after the start of dosing. The last PK sample will be taken 48 hours following the last dosing (the 9th infusion).
Estimates of multiple-dose peak time to maximum plasma concentration (Tmax) for RLS-0071.
Time frame: Pre-Dose (within 30 minutes before start of dosing); 30 minutes after the start of dosing; and 1, 2, 4, 6, 12, 18, 24, 36, and 48 hours after the start of dosing. The last PK sample will be taken 48 hours following the last dosing (the 9th infusion).
Estimates of multiple-dose area under the plasma concentration-time curve (AUC) for RLS-0071.
Time frame: Pre-Dose (within 30 minutes before start of dosing); 30 minutes after the start of dosing; and 1, 2, 4, 6, 12, 18, 24, 36, and 48 hours after the start of dosing. The last PK sample will be taken 48 hours following the last dosing (the 9th infusion).
Estimates of multiple-dose average plasma drug concentration observed (Cavg) for RLS-0071.
Time frame: Pre-Dose (within 30 minutes before start of dosing); 30 minutes after the start of dosing; and 1, 2, 4, 6, 12, 18, 24, 36, and 48 hours after the start of dosing. The last PK sample will be taken 48 hours following the last dosing (the 9th infusion).
Estimates of multiple-dose trough concentration prior to dose administration (Ctrough).
Time frame: Pre-Dose (within 30 minutes before start of dosing); 30 minutes after the start of dosing; and 1, 2, 4, 6, 12, 18, 24, 36, and 48 hours after the start of dosing. The last PK sample will be taken 48 hours following the last dosing (the 9th infusion).
Estimates of multiple-dose apparent total volume of distribution for RLS-0071.
Time frame: Pre-Dose (within 30 minutes before start of dosing); 30 minutes after the start of dosing; and 1, 2, 4, 6, 12, 18, 24, 36, and 48 hours after the start of dosing. The last PK sample will be taken 48 hours following the last dosing (the 9th infusion).
Estimates of multiple-dose apparent first-order terminal elimination half-life for RLS-0071.
Time frame: Pre-Dose (within 30 minutes before start of dosing); 30 minutes after the start of dosing; and 1, 2, 4, 6, 12, 18, 24, 36, and 48 hours after the start of dosing. The last PK sample will be taken 48 hours following the last dosing (the 9th infusion).
Assessment of dose response relationship of single and multiple doses of RLS-0071 on C1q levels and the complement activity assay.
Time frame: Through study completion at Day 28 following last dose.
Overall survival.
Time frame: Through Day 15 and through study completion at Day 28 following last dose.
Incidence of progression to respiratory failure requiring mechanical ventilation.
Time frame: Days on ventilation while in the hospital through study completion at Day 28.
Incidence of transfer to the ICU.
Time frame: Through Day 15 following last dose; through study completion at Day 28 following last dose; and duration of ICU stay days in the hospital post-dose through study completion at Day 28.
Duration of hospitalization after treatment (days).
Time frame: Through study completion at Day 28 following last dose.
Incidence, severity, and duration after treatment (days) of fever (≥ 39.0°C).
Time frame: Through study completion at Day 28 following last dose.
Incidence, severity, and duration after treatment (days) of cough per investigator assessment of CTCAE's latest version.
Time frame: Through study completion at Day 28 following last dose.
Duration of requirement for supplemental oxygen after treatment (days).
Time frame: Through study completion at Day 28 following last dose.
PaO2/FiO2
Time frame: Through study completion at Day 28 following last dose.
Incidence, severity, and duration after treatment (days) of new cardiovascular events as assessed by the investigator (e.g. myocardial infarction, stroke, TIA, ischemic limb) with CTCAE's latest version.
Time frame: Through Day 15 and through study completion at Day 28 following last dose.
Incidence, severity, and duration after treatment (days) of respiratory acidosis as assessed by the investigator with CTCAE's latest version.
Time frame: Through Day 15 and through study completion at Day 28 following last dose.
Incidence and duration after treatment (days) of dialysis.
Time frame: Through Day 15 and through study completion at Day 28 following last dose.
Levels of complement activity (eg, CH50).
Time frame: Through study completion at Day 28 following last dose.
Levels of C1q (free and bound to RLS-0071).
Time frame: Through study completion at Day 28 following last dose.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
- Individual participant dataSharing planned: No
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Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenji Cunnion, MD, MPH study chair
ReAlta Life Sciences, Inc.
Linda Dell study director
ReAlta Life Sciences, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RLS-0071 10 mg/kg and RLS-0071 40 mg/kg in people with Acute Lung Injury and ALI, run by ReAlta Life Sciences, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of Adverse Events, including Serious Adverse Events, by treatment group and dose level, including the frequency of premature discontinuation of study intervention due to Adverse Events. (time frame: Through study completion at Day 28 following last dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04574869, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.