COVID-19Phase 2NCT04495101
Study to Evaluate the Safety and Efficacy of Prolastin in Hospitalized Subjects With COVID-19
A Phase 2 study testing Prolastin and Standard Medical Treatment in people with COVID-19, run by Instituto Grifols, S.A. at 9 sites in Spain.
Trial summary
The primary objective of the study is to determine if Prolastin plus SMT can reduce the proportion of subjects dying or requiring intensive care unit (ICU) admission on or before Day 15 or who are dependent on invasive mechanical ventilation on Day 15 versus SMT alone in hospitalized subjects with Coronavirus disease… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Prolastin and Standard Medical Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 9 sitesSpain
- Study dates
- 29 Jul 2020to 10 Jun 2021
- Phase
- Phase 2
- 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
- Hospitalized male or female subject ≥ 18 years of age at the time of Screening who is being treated for COVID-19. Subjects must be screened within 48 hours (≤ 48 hours) of hospital admission.
- Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by qualitative Polymerase Chain Reaction (PCR) (reverse transcriptase [RT]-PCR) or other commercial or public health assay in any specimen during the current hospital admission prior to randomization.
- COVID-19 illness (symptoms) of any duration, including both of the following:
- Radiographic infiltrates by imaging (chest X-Ray, computerized tomography (CT) scan, etc.) and/or clinical assessment (evidence of rales/crackles on the exam) with peripheral oxygen saturation by pulse oximetry (SpO2) <94% on room air
- Any One of the following related to COVID-19: i. Ferritin > 400 nanogram per milliliter (ng/mL), ii. Lactate dehydrogenase (LDH) > 300 units per liter (U/L), iii. D-Dimers > reference range, or iv. C-reactive protein (CRP) > 40 milligram per liter (mg/L)
- Subjects provides informed consent prior to the initiation of any study procedures.
Who cannot join
- Subjects requiring invasive mechanical ventilation or ICU admission or with PaO2/FIO2 ≤ 150 mm Hg (ie, arterial oxygen in mm Hg divided by fraction inspired oxygen concentration [eg, 0.21 for room air]).
- Clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the subject at undue medical risk.
- The subjects have had a known serious anaphylactic reaction to blood, any blood-derived or plasma product, or known selective immunoglobulin A (IgA) deficiency with anti-IgA antibodies.
- A medical condition in which the infusion of additional fluid is contraindicated.
- Shock that is unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered not able to be reversed by the Principal Investigator.
- Known alpha-1 antitrypsin deficiency for which the subject is already receiving alpha1-proteinase inhibitor augmentation therapy.
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- Women who are pregnant or breastfeeding. Female subjects of child-bearing potential must have a negative test for pregnancy blood or urine human chorionic gonadotropin (HCG)-based assay at Screening/Baseline Visit.
- Subjects for whom there is limitation of therapeutic effort such as "Do not resuscitate" status.
- Currently participating in another interventional clinical trial with investigational medical product or device.
- Subjects previously requiring long-term oxygen therapy (home oxygen therapy).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
Hospital Universitari Germans Trias i Pujol
Badalona
Hospital Clínic de Barcelona
Barcelona
Hospital Universitario Valle de Hebrón
Barcelona
Hospital Universitario de Burgos
Burgos, Castille and León, 09006
Hospital Clínico San Carlos
Madrid
Hospital General Gregorio Marañón
Madrid
Hospital Universitario Infanta Leonor
Madrid
Hospital Universitario Príncipe de Asturias
Madrid
Hospital Universitario Ramón y Cajal
Madrid
About this study
Official title: A Multicenter, Randomized, Open-label, Parallel Group Pilot Study to Evaluate the Safety and Efficacy of Prolastin Plus Standard Medical Treatment (SMT) Versus SMT Alone in Hospitalized Subjects With COVID-19
The primary objective of the study is to determine if Prolastin plus SMT can reduce the proportion of subjects dying or requiring intensive care unit (ICU) admission on or before Day 15 or who are dependent on invasive mechanical ventilation on Day 15 versus SMT alone in hospitalized subjects with Coronavirus disease 2019 (COVID-19).
- Conditions
- COVID-19
- Being tested
- Prolastin, Standard Medical Treatment
- Keywords
- Coronavirus disease, Severe acute respiratory syndrome coronavirus 2, SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProlastinBiological
Also called Alpha1-proteinase inhibitor
Intravenous infusion 120 mg/kg
Standard Medical TreatmentDrug
Also called SMT
Standard medical treatment per local policies or guidelines
| Study group | Role | What they receive |
|---|---|---|
| Prolastin 120 mg/kg + Standard Medical Treatment | Experimental | Subjects will receive Prolastin, two intravenous infusion (IV) doses of 120 milligram per kilogram (mg/kg), based upon the subject's body weight, on Day 1 and Day 8. Subjects will also receive all standard of care interventions while hospitalized, from Day 1 to Day 29. Receives: Biological: Prolastin; Drug: Standard Medical Treatment |
| Standard Medical Treatment | Active comparator | Subjects will receive all standard of care interventions while hospitalized, from Day 1 to Day 29. Receives: Drug: Standard Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Dying or Requiring ICU Admission
Measured: Up to Day 15
Percentage of Subjects Who are Dependent on Invasive Mechanical Ventilation
Measured: Day 15
Secondary outcomes (14)
Change from Baseline in National Early Warning Score (NEWS)
Measured: Day 1 through Day 29
Time to Clinical Response as Assessed by: NEWS ≤ 2 Maintained for 24 hours
Measured: Day 1 through Day 29
Time to Hospital Discharge
Measured: Day 1 through Day 29
Duration of ICU Stay
Measured: Up to Day 29
Duration of Any Oxygen Use
Measured: Day 1 through Day 29
Duration of Mechanical Ventilation
Measured: Up to Day 29
Mean Change from Baseline in Ordinal Scale
Measured: Day 1 through Day 29
Absolute Value Change from Baseline in Ordinal Scale
Measured: Day 1 through Day 29
Percentage of Subjects in Each Severity Category of the 7-Point Ordinal Scale
Measured: Day 15, Day 29
Time to Sustained Normalization of Temperature
Measured: Day 1 through Day 29
Percentage of Subjects who Sustained Normalization of Temperature
Measured: Day 1 through Day 29
Number of Subjects who Develop Acute Respiratory Distress Syndrome (ARDS)
Measured: Up to Day 29
Length of Time to Clinical Progression
Measured: Up to Day 29
Mortality Through Day 29
Measured: Up to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start29 Jul 2020
- Primary completion26 Apr 2021
- Study completion10 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Grifols, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495101
- Sponsor's protocol ID
- GC2005
- Other IDs
- 2020-001953-36
- Status last verified
- Jul 2021
- First submitted
- 28 Jul 2020
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-label, Parallel Group Pilot Study to Evaluate the Safety and Efficacy of Prolastin Plus Standard Medical Treatment (SMT) Versus SMT Alone in Hospitalized Subjects With COVID-19
- ClinicalTrials.gov ID
- NCT04495101
- Acronym / sponsor ID
- GC2005
- Conditions
- COVID-19
- Keywords
- Coronavirus disease, Severe acute respiratory syndrome coronavirus 2, SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Instituto Grifols, S.A.Industry (pharma, biotech, devices)
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 31 Jul 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 primary objective of the study is to determine if Prolastin plus SMT can reduce the proportion of subjects dying or requiring intensive care unit (ICU) admission on or before Day 15 or who are dependent on invasive mechanical ventilation on Day 15 versus SMT alone in hospitalized subjects with Coronavirus disease 2019 (COVID-19).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolastin 120 mg/kg + Standard Medical Treatment | Experimental | Biological: Prolastin, Drug: Standard Medical TreatmentSubjects will receive Prolastin, two intravenous infusion (IV) doses of 120 milligram per kilogram (mg/kg), based upon the subject's body weight, on Day 1 and Day 8. Subjects will also receive all standard of care interventions while hospitalized, from Day 1 to Day 29. |
| Standard Medical Treatment | Active comparator | Drug: Standard Medical TreatmentSubjects will receive all standard of care interventions while hospitalized, from Day 1 to Day 29. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hospitalized male or female subject ≥ 18 years of age at the time of Screening who is being treated for COVID-19. Subjects must be screened within 48 hours (≤ 48 hours) of hospital admission.
- Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by qualitative Polymerase Chain Reaction (PCR) (reverse transcriptase [RT]-PCR) or other commercial or public health assay in any specimen during the current hospital admission prior to randomization.
- COVID-19 illness (symptoms) of any duration, including both of the following:
- Subjects provides informed consent prior to the initiation of any study procedures.
Key exclusion criteria (10 listed)
- Subjects requiring invasive mechanical ventilation or ICU admission or with PaO2/FIO2 ≤ 150 mm Hg (ie, arterial oxygen in mm Hg divided by fraction inspired oxygen concentration [eg, 0.21 for room air]).
- Clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the subject at undue medical risk.
- The subjects have had a known serious anaphylactic reaction to blood, any blood-derived or plasma product, or known selective immunoglobulin A (IgA) deficiency with anti-IgA antibodies.
- A medical condition in which the infusion of additional fluid is contraindicated.
- Shock that is unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered not able to be reversed by the Principal Investigator.
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 |
|---|---|---|
| ProlastinAlso: Alpha1-proteinase inhibitorIntravenous infusion 120 mg/kg | Biological | Prolastin 120 mg/kg + Standard Medical Treatment |
| Standard Medical TreatmentAlso: SMTStandard medical treatment per local policies or guidelines | Drug | Prolastin 120 mg/kg + Standard Medical Treatment, Standard Medical Treatment |
Primary outcome
Percentage of Subjects Dying or Requiring ICU Admission
Time frame: Up to Day 15
Percentage of Subjects Who are Dependent on Invasive Mechanical Ventilation
Time frame: Day 15
14 secondary outcomes
Change from Baseline in National Early Warning Score (NEWS)
Time frame: Day 1 through Day 29
Time to Clinical Response as Assessed by: NEWS ≤ 2 Maintained for 24 hours
Time frame: Day 1 through Day 29
Time to Hospital Discharge
Time frame: Day 1 through Day 29
Duration of ICU Stay
Time frame: Up to Day 29
Duration of Any Oxygen Use
Time frame: Day 1 through Day 29
Duration of Mechanical Ventilation
Time frame: Up to Day 29
Mean Change from Baseline in Ordinal Scale
Time frame: Day 1 through Day 29
Absolute Value Change from Baseline in Ordinal Scale
Time frame: Day 1 through Day 29
Percentage of Subjects in Each Severity Category of the 7-Point Ordinal Scale
Time frame: Day 15, Day 29
Time to Sustained Normalization of Temperature
Time frame: Day 1 through Day 29
Percentage of Subjects who Sustained Normalization of Temperature
Time frame: Day 1 through Day 29
Number of Subjects who Develop Acute Respiratory Distress Syndrome (ARDS)
Time frame: Up to Day 29
Length of Time to Clinical Progression
Time frame: Up to Day 29
Mortality Through Day 29
Time frame: Up to Day 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prolastin and Standard Medical Treatment in people with COVID-19, run by Instituto Grifols, S.A. at 9 sites in Spain.
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 6 inclusion and 10 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 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of Subjects Dying or Requiring ICU Admission (time frame: Up to Day 15). The study lists 2 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 8 Jul 2021.