Covid-19Phase 1NCT04646044
A Placebo Controlled Trial of Bempegaldesleukin (BEMPEG; NKTR-214) With Standard of Care in Patients With Mild COVID-19
A Phase 1 study testing Bempegaldesleukin in people with Covid-19 and Coronavirus Disease 2019, run by Nektar Therapeutics at 4 sites in United States.
Trial summary
The main purpose of this phase-1b, multicenter, randomized double-blind, placebo-controlled, trial is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of bempegaldesleukin (BEMPEG; NKTR-214) in combination with standard of care (SOC) in adult patients with mild COVID-19 (coronavirus disease… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19, Coronavirus Disease 2019
- What is being tested?
- Bempegaldesleukin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- 13 Nov 2020to 18 May 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients, age 18 years or older on the day of signing the informed consent form.
- Agrees to admission to an in-patient facility for monitoring from Days 1 to 8, inclusive.
- Symptoms of mild illness with COVID-19 without shortness of breath, dyspnea, or clinical signs indicative of more serious COVID-19.
- Laboratory confirmed SARS-CoV-2 infection within 4 days prior to the screening visit or during the 7-day screening period.
- Respiratory rate < 20 breaths per minute, heart rate < 90 beats per minute (bpm).
- Oxygen saturation by pulse oximetry > 93% on room air.
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- Body mass index < 35 kg/m2.
- Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min.
- Alanine transaminase (ALT) or aspartate transaminase (AST) < 2 x upper limit of normal (ULN) and total bilirubin < 1.5 x ULN.
- Agrees to not participate in another clinical trial for the treatment of COVID-19 while on study unless the patient's condition has worsened and is considered to be moderate, severe, or critical by the Investigator.
Who cannot join
- Shortness of breath, hypoxia, or signs of serious lower airway disease.
- C-reactive protein, lactate dehydrogenase (LDH), or interleukin-6 (IL-6) > 1.5 x ULN.
- D-dimer or ferritin > 1.5 x ULN.
- Imminently requiring, or currently on, mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
- Systolic blood pressure < 90 mm Hg or diastolic blood pressure < 60 mm Hg.
- Evidence of acute respiratory distress syndrome (ARDS) or systemic inflammatory response syndrome (SIRS)/shock.
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- Known cardiovascular history, including unstable or deteriorating cardiac disease.
- Autoimmune disease.
- History of pulmonary embolism (PE), deep vein thrombosis (DVT), or prior clinically significant venous or non-cerebrovascular accident/transient ischemic attack arterial thromboembolic event.
- Central nervous system disease or dysfunction.
- Requirement for > 2 anti-hypertensive medications.
- Unwilling to refrain from alcohol consumption from Day 1 of admission to the in-patient facility until discharge from the facility.
- Adrenal insufficiency.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
A G A Clinical Trials - HyperCore - PPDS
Hialeah, Florida, 33012
New Generation Medical Research
Hialeah, Florida, 33016
SMS Clinical Research, LLC
Mesquite, Texas, 75149
Clinical Site Partners - Winter Park - HyperCore -PPDS
Winter Park, Florida, 32789
About this study
Official title: A Phase 1b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Bempegaldesleukin (BEMPEG; NKTR-214) Plus Standard of Care Versus Placebo Plus Standard of Care in Adults With Mild COVID-19
The main purpose of this phase-1b, multicenter, randomized double-blind, placebo-controlled, trial is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of bempegaldesleukin (BEMPEG; NKTR-214) in combination with standard of care (SOC) in adult patients with mild COVID-19 (coronavirus disease 2019). The trial will also define the recommended phase 2 dose (RP2D) of bempegaldesleukin in patients with mild COVID-19.
- Conditions
- Covid-19, Coronavirus Disease 2019
- Being tested
- Bempegaldesleukin, Standard of Care, Placebo
- Keywords
- BEMPEG, Bempegaldesleukin, CD122, CD122-Biased Agonist, CD122-Biased Cytokine, Coronavirus Disease, COVID-19, IL-2 receptor agonist, Lymphopenia, Mild COVID, NKTR-214, SARS-CoV-2, Severe Acute Respiratory Syndrome Coronavirus 2
- Medical subject headings
- COVID-19, Lymphopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BempegaldesleukinDrug
Also called NKTR-214, BEMPEG
Administered as an intravenous infusion
Standard of CareDrug
Standard of Care Treatment for COVID-19 Infection
PlaceboOther
Administered as an intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Bempegaldesleukin IV + Standard of Care | Experimental | Not described Receives: Drug: Bempegaldesleukin; Drug: Standard of Care |
| Placebo + Standard of Care | Placebo comparator | Not described Receives: Drug: Standard of Care; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of Bempegaldesleukin [Pharmacokinetic Parameter].
Area under the serum concentration-time curve (AUC) of bempegaldesleukin calculated from time 0 to 168 hours.
Measured: Day 1: Predose, 0.5, 24, 48, 72, 120, and 168 hours post dose.
Cmax of Bempegaldesleukin [Pharmacokinetic Parameter].
Maximum observed serum concentration (Cmax) of bempegaldesleukin.
Measured: Day 1: Predose, 0.5, 24, 48, 72, 120, and 168 hours post dose.
Tmax of Bempegaldesleukin [Pharmacokinetic Parameter].
Time to maximum concentration of bempegaldesleukin. Cmax = maximum concentration. Tmax = time to maximum concentration.
Measured: Day 1: Predose, 0.5, 24, 48, 72, 120, and 168 hours post dose.
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
Safety and Tolerability of bempegaldesleukin (starting at dose 0.00075 mg/kg) in combination with SOC was evaluated by incidence of Treatment-Emergent Adverse Events of Any Grade, Grade 3-4, and Grade 5 (Death).
Measured: Safety and tolerability were evaluated from baseline up to approximately 30 days.
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Dose finding for this study was based on the assessment of DLT of bempegaldesleukin dose levels. Number and percentage of patients with any DLT were summarized by bempegaldesleukin dose level in bempegaldesleukin plus SOC treatment groups [0.00075 mg/kg, N=5; 0.0015 mg/kg, N=5; and 0.003 mg/kg, N=5] and placebo plus SOC (N=15).
Adverse events related to study drug(s) that were defined as DLTs included the following:
- Any Grade ≥ 3 drug-related AE.
- Any Grade ≥ 3 drug-related laboratory abnormality that was clinically significant per the Investigator.
- Respiratory compromise or other virus-related AE attributed to worsening COVID-19, such as severe hypoxia, cyanosis, or chest pain/pressure.
The event was considered a DLT if it was confirmed to be at least possibly related to study drug, met any of the above definitions, and was confirmed to have occurred in a patient treated with bempegaldesleukin.
Measured: The DLT evaluation period was up to approximately 7 days following the bempegaldesleukin treatment.
Percent Change From Baseline for Absolute Lymphocyte Count (ALC) by Dose/Arm.
To assess the effect of bempegaldesleukin on the time course and extent of changes in absolute lymphocyte counts (ALC). Data are reported by dose and arm for Day 8 compared to baseline.
Measured: ALC was evaluated from baseline up to 7 days (Day 8) following the study drug administration.
Secondary outcomes (2)
Percentage of Patients Who Require Supplemental Oxygen.
The percentage of patients requiring supplemental oxygen was evaluated as part of disease measurements to assess efficacy.
No patient in the study required supplemental oxygen.
Measured: From baseline, following the administration of study drug approximately up to 30 days.
Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale.
The WHO Clinical Progression Scale scores and descriptors are as follows: 0- Uninfected; no viral RNA detected; 1- Asymptomatic; viral RNA detected; 2- Symptomatic; independent; 3- Symptomatic; assistance needed; 4- Hospitalized, no oxygen therapy(a); 5- Hospitalized; oxygen by mask or nasal prongs ; 6- Hospitalized; oxygen by non-invasive ventilation or high-flow; 7- Intubation and mechanical ventilation, PaO2/FiO2 ≥ 150 or SpO2/FiO2 ≥ 200; 8- Mechanical ventilation, PaO2/FiO2 < 150 (SpO2/FiO2 < 200) or vasopressors; 9- Mechanical ventilation, PaO2/FiO2 < 150 and vasopressors, dialysis, or ECMO; 10- Death. The data are reported for Day 8 by arm. There were no scores rated 3 and higher per this scale at any timepoint.
Abbreviations: ECMO = extracorporeal membrane oxygenation; FiO2 = fraction of inspired oxygen; PaO2 = partial pressure of arterial oxygen; SpO2 = oxygen saturation
(a) If hospitalized for isolation only, record status as for ambulatory patient.
Source: WHO 2020.
Measured: From baseline up to 7 days (Day 8) following the study drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start13 Nov 2020
- Primary completion11 May 2021
- Study completion18 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid-19Studies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nektar Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Nektar Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646044
- Sponsor's protocol ID
- 20-214-34
- Status last verified
- Mar 2024
- First submitted
- 14 Nov 2020
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Bempegaldesleukin (BEMPEG; NKTR-214) Plus Standard of Care Versus Placebo Plus Standard of Care in Adults With Mild COVID-19
- ClinicalTrials.gov ID
- NCT04646044
- Acronym / sponsor ID
- 20-214-34
- Conditions
- Covid-19, Coronavirus Disease 2019
- Keywords
- BEMPEG, Bempegaldesleukin, CD122, CD122-Biased Agonist, CD122-Biased Cytokine, Coronavirus Disease, COVID-19, IL-2 receptor agonist
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nektar TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 11 May 2021 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 27 Nov 2020 (actual)
- Results
- Posted 12 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this phase-1b, multicenter, randomized double-blind, placebo-controlled, trial is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of bempegaldesleukin (BEMPEG; NKTR-214) in combination with standard of care (SOC) in adult patients with mild COVID-19 (coronavirus disease 2019). The trial will also define the recommended phase 2 dose (RP2D) of bempegaldesleukin in patients with mild COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bempegaldesleukin IV + Standard of Care | Experimental | Drug: Bempegaldesleukin, Drug: Standard of Care |
| Placebo + Standard of Care | Placebo comparator | Drug: Standard of Care, Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female patients, age 18 years or older on the day of signing the informed consent form.
- Agrees to admission to an in-patient facility for monitoring from Days 1 to 8, inclusive.
- Symptoms of mild illness with COVID-19 without shortness of breath, dyspnea, or clinical signs indicative of more serious COVID-19.
- Laboratory confirmed SARS-CoV-2 infection within 4 days prior to the screening visit or during the 7-day screening period.
- Respiratory rate < 20 breaths per minute, heart rate < 90 beats per minute (bpm).
Key exclusion criteria (14 listed)
- Shortness of breath, hypoxia, or signs of serious lower airway disease.
- C-reactive protein, lactate dehydrogenase (LDH), or interleukin-6 (IL-6) > 1.5 x ULN.
- D-dimer or ferritin > 1.5 x ULN.
- Imminently requiring, or currently on, mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
- Systolic blood pressure < 90 mm Hg or diastolic blood pressure < 60 mm Hg.
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 |
|---|---|---|
| BempegaldesleukinAlso: NKTR-214, BEMPEGAdministered as an intravenous infusion | Drug | Bempegaldesleukin IV + Standard of Care |
| Standard of CareStandard of Care Treatment for COVID-19 Infection | Drug | Bempegaldesleukin IV + Standard of Care, Placebo + Standard of Care |
| PlaceboAdministered as an intravenous infusion | Other | Placebo + Standard of Care |
Primary outcome
AUC of Bempegaldesleukin [Pharmacokinetic Parameter].
Time frame: Day 1: Predose, 0.5, 24, 48, 72, 120, and 168 hours post dose.
Area under the serum concentration-time curve (AUC) of bempegaldesleukin calculated from time 0 to 168 hours.
Cmax of Bempegaldesleukin [Pharmacokinetic Parameter].
Time frame: Day 1: Predose, 0.5, 24, 48, 72, 120, and 168 hours post dose.
Maximum observed serum concentration (Cmax) of bempegaldesleukin.
Tmax of Bempegaldesleukin [Pharmacokinetic Parameter].
Time frame: Day 1: Predose, 0.5, 24, 48, 72, 120, and 168 hours post dose.
Time to maximum concentration of bempegaldesleukin. Cmax = maximum concentration. Tmax = time to maximum concentration.
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Safety and tolerability were evaluated from baseline up to approximately 30 days.
Safety and Tolerability of bempegaldesleukin (starting at dose 0.00075 mg/kg) in combination with SOC was evaluated by incidence of Treatment-Emergent Adverse Events of Any Grade, Grade 3-4, and Grade 5 (Death).
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Time frame: The DLT evaluation period was up to approximately 7 days following the bempegaldesleukin treatment.
Dose finding for this study was based on the assessment of DLT of bempegaldesleukin dose levels. Number and percentage of patients with any DLT were summarized by bempegaldesleukin dose level in bempegaldesleukin plus SOC treatment groups [0.00075 mg/kg, N=5; 0.0015 mg/kg, N=5; and 0.003 mg/kg, N=5] and placebo plus SOC (N=15). Adverse events related to study drug(s) that were defined as DLTs included the following: * Any Grade ≥ 3 drug-related AE. * Any Grade ≥ 3 drug-related laboratory abnormality that was clinically significant per the Investigator. * Respiratory compromise or other virus-related AE attributed to worsening COVID-19, such as severe hypoxia, cyanosis, or chest pain/pressure. The event was considered a DLT if it was confirmed to be at least possibly related to study drug, met any of the above definitions, and was confirmed to have occurred in a patient treated with bempegaldesleukin.
Percent Change From Baseline for Absolute Lymphocyte Count (ALC) by Dose/Arm.
Time frame: ALC was evaluated from baseline up to 7 days (Day 8) following the study drug administration.
To assess the effect of bempegaldesleukin on the time course and extent of changes in absolute lymphocyte counts (ALC). Data are reported by dose and arm for Day 8 compared to baseline.
2 secondary outcomes
Percentage of Patients Who Require Supplemental Oxygen.
Time frame: From baseline, following the administration of study drug approximately up to 30 days.
Change From Baseline on the Daily Collection World Health Organization (WHO) Clinical Progression Scale, an 11-point Clinical Status Ordinal Scale.
Time frame: From baseline up to 7 days (Day 8) following the study drug administration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Study Director study director
Nektar Therapeutics
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bempegaldesleukin in people with Covid-19 and Coronavirus Disease 2019, run by Nektar Therapeutics at 4 sites 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 10 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: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
AUC of Bempegaldesleukin [Pharmacokinetic Parameter]. (time frame: Day 1: Predose, 0.5, 24, 48, 72, 120, and 168 hours post dose.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2024.