Covid19Phase 3NCT04675086
Aralast NP With Antiviral Treatment and Standard of Care Versus Antiviral Treatment With Standard of Care in Hospitalized Patients With Pneumonia and COVID-19 Infection
A Phase 3 study testing alpha1-proteinase inhibitor and Antiviral Agents in people with Covid19 and Pneumonia, Viral, run by Blessing Corporate Services, Inc at 1 site in United States.
Trial summary
This is a Randomized, Open-Label Study of the Efficacy and Safety of Aralast NP Infusion Therapy with Antiviral Treatment and standard of care versus Antiviral Treatment and standard of care (control group) in Hospitalized Patients with Pneumonia and COVID-19 Infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Pneumonia, Viral
- What is being tested?
- alpha1-proteinase inhibitor and Antiviral Agents
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2021to Dec 2021
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject will sign and date an informed consent form.
- Hospitalized subjects will be 18 years of age or older.
- Lab confirmed positive for COVID-19 within 72 hours prior to randomization.
- Subjects with COVID-19 with evidence of pneumonia (diagnosed by a chest x-ray) on supplemental oxygen or non-invasive ventilation with PO2/FiO2 ratio less than 300.
- Subject must have one of the following elevated inflammatory markers: C-reactive protein >40mg/L; D-Dimers > 250ng/mL DDU or >0.5mcg/mL FEU; Ferritin >400ng/mL; LDH >300U/L.
Who cannot join
- Subject is on mechanical ventilation at time of screening.
- Subject is not expected to survive greater than 48 hours from screening based on PI judgement.
- Prior or current treatment with anti-IL-6, anti-IL-6 R antagonist or JAK inhibitors.
- Subject is on immunosuppressive agents, with the exception of corticosteroids for severe COVID-19 patients at the discretion of the PI.
- Subject is currently participating in a trial for any other investigational drug.
- Subject is on another plasma derived product or has received plasma or blood products within the last 48 hours.
Show all 14Show fewer
- Subject is pregnant or breastfeeding.
- The subject, or the next of kin/power of attorney are not able to give the proper informed consent.
- The subject has a known IgA deficiency with anti-IgA antibodies.
- Subject has a known Alpha-1 Antitrypsin Deficiency.
- Subject has antibodies against alpha-1 proteinase inhibitor
- Subject has renal, liver or multisystem organ failure
- Subject has known history of hypersensitivity following infusions of human blood or blood components (eg, human immunoglobulins or human albumin).
- Positive serological test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
Trial locations and contacts
1 site in 1 country.
United States1 site
Blessing Corporate Services, Inc
Hannibal, Missouri, 63401
About this study
Official title: A Randomized, Open-Label Study of the Efficacy and Safety of Aralast NP, an Alpha-1 Antitrypsin Infusion Therapy With Antiviral Treatment and Standard of Care Versus Antiviral Treatment With Standard of Care in Hospitalized Patients With Pneumonia and COVID-19 Infection
This is a Randomized, Open-Label Study of the Efficacy and Safety of Aralast NP Infusion Therapy with Antiviral Treatment and standard of care versus Antiviral Treatment and standard of care (control group) in Hospitalized Patients with Pneumonia and COVID-19 Infection.
Read the detailed description
Approximately 20 subjects in total will be randomized with 1:1 ratio to the high dose of Aralast NP infusion therapy plus antiviral and standard of care versus antiviral therapy and standard of care.
Each subject will participate in the study for 24 days and have one safety follow-up phone call at 30 days. Active treatment will last 17 days, subject will be dosed on Days 1, 3, 5, 7, 9 and have a final booster infusion on Day 17. If the subject is discharged from hospital, any remaining infusions and assessments will be conducted via outpatient clinic visit or home health visit. Subjects will have an in-person visit (hospital or clinic) on Day 24 for a CT scan and follow-up assessment.
Efficacy will be evaluated by measuring the duration of new non-invasive ventilation or high flow oxygen used. Additional endpoints include clinical status, cytokine levels, oxygen requirements, SOFA scores, risk of coagulopathy, need for Vasopressors, mortality during the treatment period, PK samples, average days spent in the hospital/ICU, and number of days without a fever.
- Conditions
- Covid19, Pneumonia, Viral
- Being tested
- alpha1-proteinase inhibitor, Antiviral Agents
- Medical subject headings
- COVID-19, Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alpha1-proteinase inhibitorDrug
Also called Aralast NP
Alpha1-Proteinase Inhibitor (Human), AralastÔ, is a sterile, stable, lyophilized preparation of purified human alpha1-proteinase inhibitor (a1-PI), also known as alpha1-antitrypsin.
Antiviral AgentsDrug
Also called Remdesivir
a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization
| Study group | Role | What they receive |
|---|---|---|
| Aralast NP + Antiviral Treatment + Standard of Care | Experimental | The investigational product is alpha1-proteinase inhibitor, administered as a loading dose of 120mg/kg/body weight intravenous infusion on the first day, and then 60mg/kg/BW intravenous infusion on Days 3, 5, 7 and 9. Booster infusion of 120 mg/kg/BWon Day 17.
The Antiviral treatment is Remdesivir. For patients not requiring invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days. Recommended dosage in adults and pediatric patients 12 years of age and older and weighing at least 40 kg: a single loading dose of Remdesivir 200 mg on Day 1 followed by once-daily maintenance doses of Remdesivir 100 mg from Day 2 infused over 30 to 120 minutes
Standard of Care treatments are at the investigator's discretion based on best practices. Receives: Drug: alpha1-proteinase inhibitor; Drug: Antiviral Agents |
| Antiviral Treatment + Standard of Care | Active comparator | The Antiviral treatment is Remdesivir. For patients not requiring invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days. Recommended dosage in adults and pediatric patients 12 years of age and older and weighing at least 40 kg: a single loading dose of Remdesivir 200 mg on Day 1 followed by once-daily maintenance doses of Remdesivir 100 mg from Day 2 infused over 30 to 120 minutes
Standard of Care treatments are at the investigator's discretion based on best practices. Receives: Drug: Antiviral Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of new non-invasive ventilation or high flow oxygen use (measured by days)
Measured: 365 Days
Secondary outcomes (14)
Clinical status on a 7-point ordinal scale (from 1=death to 7=not hospitalized
Measured: 1 Year
The percentage change in cytokine levels from screening through day 10, Day 17 and Day 24
Measured: 10 Days, 17 Days, & 24 Days
The percentage change in oxygen requirements including PEEP and FiO2 from screening through day 10.
Measured: 10 Days
The percentage of subjects that required mechanical ventilation during the treatment period.
Measured: 1 Year
The percent of patients with a SOFA score between 0-6 during treatment period.
Measured: 1 Year
The percent of mortality during the treatment period.
Measured: 1 Year
Evaluate the need, dosage and duration of vasopressors (number of days and average daily dose).
Measured: 1 Year
Number of Days fever free (defined by temperature of <100°F (oral) for 24 hours)
Measured: 1 Year
To evaluate the average number of days in the ICU
Measured: 1 Year
To evaluate the average number of days in the hospital
Measured: 1 Year
To evaluate the number of days with a PO2/FiO2 <300 or other parameters decided on with oxygen
Measured: 1 Year
The risk of coagulopathy by measuring Prothrombin time & Partial Thromboplastin time
Measured: 1 Year
The risk of coagulopathy by measuring D-Dimer
Measured: 1 Year
The risk of coagulopathy by measuring Platelet Counts
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study startJan 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Administrative Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized with 1:1 ratio to the high dose of Aralast NP infusion therapy plus antiviral and standard of care versus antiviral therapy and standard of care.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blessing Corporate Services, Inc
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Responsible party
- Sponsor
- Investigators
- Humam Farah, MD, Principal investigator, Employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675086
- Sponsor's protocol ID
- CCR-2020-103188
- Status last verified
- Dec 2020
- First submitted
- 25 Nov 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label Study of the Efficacy and Safety of Aralast NP, an Alpha-1 Antitrypsin Infusion Therapy With Antiviral Treatment and Standard of Care Versus Antiviral Treatment With Standard of Care in Hospitalized Patients With Pneumonia and COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04675086
- Acronym / sponsor ID
- CCR-2020-103188
- Conditions
- Covid19, Pneumonia, Viral
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Administrative Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Blessing Corporate Services, IncUniversity, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Study start
- Jan 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 19 Dec 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.
This is a Randomized, Open-Label Study of the Efficacy and Safety of Aralast NP Infusion Therapy with Antiviral Treatment and standard of care versus Antiviral Treatment and standard of care (control group) in Hospitalized Patients with Pneumonia and COVID-19 Infection.
Detailed description
Approximately 20 subjects in total will be randomized with 1:1 ratio to the high dose of Aralast NP infusion therapy plus antiviral and standard of care versus antiviral therapy and standard of care.
Each subject will participate in the study for 24 days and have one safety follow-up phone call at 30 days. Active treatment will last 17 days, subject will be dosed on Days 1, 3, 5, 7, 9 and have a final booster infusion on Day 17. If the subject is discharged from hospital, any remaining infusions and assessments will be conducted via outpatient clinic visit or home health visit. Subjects will have an in-person visit (hospital or clinic) on Day 24 for a CT scan and follow-up assessment.
Efficacy will be evaluated by measuring the duration of new non-invasive ventilation or high flow oxygen used. Additional endpoints include clinical status, cytokine levels, oxygen requirements, SOFA scores, risk of coagulopathy, need for Vasopressors, mortality during the treatment period, PK samples, average days spent in the hospital/ICU, and number of days without a fever.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized with 1:1 ratio to the high dose of Aralast NP infusion therapy plus antiviral and standard of care versus antiviral therapy and standard of care.
| Arm | Type | Receives |
|---|---|---|
| Aralast NP + Antiviral Treatment + Standard of Care | Experimental | Drug: alpha1-proteinase inhibitor, Drug: Antiviral AgentsThe investigational product is alpha1-proteinase inhibitor, administered as a loading dose of 120mg/kg/body weight intravenous infusion on the first day, and then 60mg/kg/BW intravenous infusion on Days 3, 5, 7 and 9. Booster infusion of 120 mg/kg/BWon Day 17. The Antiviral treatment is Remdesivir. For patients not requiring invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days. Recommended dosage in adults and pediatric patients 12 years of age and older and weighing at least 40 kg: a single loading dose of Remdesivir 200 mg on Day 1 followed by once-daily maintenance doses of Remdesivir 100 mg from Day 2 infused over 30 to 120 minutes Standard of Care treatments are at the investigator's discretion based on best practices. |
| Antiviral Treatment + Standard of Care | Active comparator | Drug: Antiviral AgentsThe Antiviral treatment is Remdesivir. For patients not requiring invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days. Recommended dosage in adults and pediatric patients 12 years of age and older and weighing at least 40 kg: a single loading dose of Remdesivir 200 mg on Day 1 followed by once-daily maintenance doses of Remdesivir 100 mg from Day 2 infused over 30 to 120 minutes Standard of Care treatments are at the investigator's discretion based on best practices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject will sign and date an informed consent form.
- Hospitalized subjects will be 18 years of age or older.
- Lab confirmed positive for COVID-19 within 72 hours prior to randomization.
- Subjects with COVID-19 with evidence of pneumonia (diagnosed by a chest x-ray) on supplemental oxygen or non-invasive ventilation with PO2/FiO2 ratio less than 300.
- Subject must have one of the following elevated inflammatory markers: C-reactive protein >40mg/L; D-Dimers > 250ng/mL DDU or >0.5mcg/mL FEU; Ferritin >400ng/mL; LDH >300U/L.
Key exclusion criteria (14 listed)
- Subject is on mechanical ventilation at time of screening.
- Subject is not expected to survive greater than 48 hours from screening based on PI judgement.
- Prior or current treatment with anti-IL-6, anti-IL-6 R antagonist or JAK inhibitors.
- Subject is on immunosuppressive agents, with the exception of corticosteroids for severe COVID-19 patients at the discretion of the PI.
- Subject is currently participating in a trial for any other investigational drug.
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 |
|---|---|---|
| alpha1-proteinase inhibitorAlso: Aralast NPAlpha1-Proteinase Inhibitor (Human), AralastÔ, is a sterile, stable, lyophilized preparation of purified human alpha1-proteinase inhibitor (a1-PI), also known as alpha1-antitrypsin. | Drug | Aralast NP + Antiviral Treatment + Standard of Care |
| Antiviral AgentsAlso: Remdesivira SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization | Drug | Antiviral Treatment + Standard of Care, Aralast NP + Antiviral Treatment + Standard of Care |
Primary outcome
Duration of new non-invasive ventilation or high flow oxygen use (measured by days)
Time frame: 365 Days
14 secondary outcomes
Clinical status on a 7-point ordinal scale (from 1=death to 7=not hospitalized
Time frame: 1 Year
The percentage change in cytokine levels from screening through day 10, Day 17 and Day 24
Time frame: 10 Days, 17 Days, & 24 Days
The percentage change in oxygen requirements including PEEP and FiO2 from screening through day 10.
Time frame: 10 Days
The percentage of subjects that required mechanical ventilation during the treatment period.
Time frame: 1 Year
The percent of patients with a SOFA score between 0-6 during treatment period.
Time frame: 1 Year
The percent of mortality during the treatment period.
Time frame: 1 Year
Evaluate the need, dosage and duration of vasopressors (number of days and average daily dose).
Time frame: 1 Year
Number of Days fever free (defined by temperature of <100°F (oral) for 24 hours)
Time frame: 1 Year
To evaluate the average number of days in the ICU
Time frame: 1 Year
To evaluate the average number of days in the hospital
Time frame: 1 Year
To evaluate the number of days with a PO2/FiO2 <300 or other parameters decided on with oxygen
Time frame: 1 Year
The risk of coagulopathy by measuring Prothrombin time & Partial Thromboplastin time
Time frame: 1 Year
The risk of coagulopathy by measuring D-Dimer
Time frame: 1 Year
The risk of coagulopathy by measuring Platelet Counts
Time frame: 1 Year
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 21 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Humam Farah, MD principal investigator
Employee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing alpha1-proteinase inhibitor and Antiviral Agents in people with Covid19 and Pneumonia, Viral, run by Blessing Corporate Services, 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 21 Dec 2020. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Duration of new non-invasive ventilation or high flow oxygen use (measured by days) (time frame: 365 Days). 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 21 Dec 2020.