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COVID-19Phase 2NCT04432324

Study to Evaluate the Safety and Efficacy of High Dose IVIG in Hospitalized Participants With Coronavirus Disease (COVID-19)

A Phase 2 study testing Intravenous Immune Globulin and Standard Medical Treatment in people with COVID-19, run by Instituto Grifols, S.A. at 10 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to determine if high dose Intravenous IVIG plus SMT can reduce the proportion of participants dying or requiring intensive care unit (ICU) admission on or before Day 29 or who are dependent on high flow oxygen devices or invasive mechanical ventilation on Day 29 versus SMT alone in… 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?
Intravenous Immune Globulin 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
10 sitesSpain
Study dates
2 Jun 2020to 3 Mar 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 time of Screening who is being treated for COVID-19.
  • 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 (of any type) in any specimen during the current hospital admission prior to randomization.
  • COVID-19 illness (symptoms) of any duration with radiographic infiltrates by imaging (Chest X-Ray, Computed tomography (CT) scan, etc.).
  • PaO2/FIO2 ratio > 300 to ≤ 450 mmHg (i.e., arterial oxygen in mmHg divided by fraction inspired oxygen concentration [e.g., 0.21 for 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).
  • Subject (or a legal representative or a nearest relative or a relative by marriage, as appropriate) provides oral informed consent prior to initiation of any study procedures.

Who cannot join

  • Subject requires invasive mechanical ventilation or ICU admission.
  • 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 subject has had a known (documented) serious anaphylactic reaction to blood, any blood-derived or plasma product or commercial immunoglobulin.
  • Subject has known (documented) hereditary fructose intolerance (HFI).
  • 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 by the Principal Investigator not able to be reversed.
Show all 11Show fewer
  • Subject with known (documented) thrombotic complications to polyclonal IVIG therapy in the past.
  • Subject with current or prior (within the past 1 month) myocardial infarction, stroke, deep vein thrombosis, or thromboembolic event.
  • Subject with limitations of therapeutic effort (eg, 'do not resuscitate' status).
  • Female subject who are pregnant or of child-bearing potential with a positive test for pregnancy blood or urine human chorionic gonadotropin (HCG)-based assay at Screening/Baseline.
  • Subject participating in another interventional clinical trial with investigational medical product or device.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Spain10 sites

  • Hospital Germans Trias i Pujol

    Badalona, 08916

  • Hospital Del Mar

    Barcelona, 08003

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitari de Bellvitge

    Barcelona, 08907

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, CP 08041

  • Hospital Universitario de Getafe

    Getafe, 28905

  • Hospital Arnau de Vilanova

    Lleida, 25198

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario Infanta Sofía

    San Sebastián de los Reyes, Madrid, 28702

Other trials in Spain

About this study

Official title: A Multicenter, Randomized, Open-label Parallel Group Pilot Study to Evaluate Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Hospitalized Subjects With COVID-19

The purpose of the study is to determine if high dose Intravenous IVIG plus SMT can reduce the proportion of participants dying or requiring intensive care unit (ICU) admission on or before Day 29 or who are dependent on high flow oxygen devices or invasive mechanical ventilation on Day 29 versus SMT alone in hospitalized participants with COVID-19.

Conditions
COVID-19
Being tested
Intravenous Immune Globulin, 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.

  • Intravenous Immune GlobulinBiological

    Also called Flebogamma DIF

    IVIG Intravenous infusion

  • Standard Medical TreatmentDrug

    SMT

Study groups in NCT04432324
Study groupRoleWhat they receive
Intravenous Immune Globulin + Standard Medical TreatmentExperimentalParticipants will receive the first intravenous (IV) infusion of IVIG on Day 1 up to a net dose of 2 gram per kilogram (g/kg), based upon participant's (body weight) administered in divided doses as infusions of 500 milligram per kilogram (mg/kg), based upon participant's body weight, over 4 days or 400 mg/kg, based upon participant's body weight, over 5 days. Participants will also receive all standard of care interventions while hospitalized, from Day 1 to Day 29.
Receives: Biological: Intravenous Immune Globulin; Drug: Standard Medical Treatment
Standard Medical TreatmentActive comparatorParticipants will receive all standard of care interventions required throughout the participant's hospitalization, 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.

  1. Percentage of Participants Dying or Requiring ICU Admission

    Measured: Up to Day 29

  2. Percentage of Participants Who are Dependent on High Flow Oxygen Devices or Invasive Mechanical Ventilation

    Measured: Day 29

Secondary outcomes (13)

  1. Change from Baseline in National Early Warning Score (NEWS)

    Measured: Day 1 through Day 29

  2. Time to Clinical Response as Assessed by: NEWS ≤ 2 Maintained for 24 hours

    Measured: Day 1 through Day 29

  3. Time to Hospital Discharge

    Measured: Day 1 through Day 29

  4. Duration of ICU Stay

    Measured: Up to Day 29

  5. Duration of Any Oxygen Use

    Measured: Day 1 through Day 29

  6. Duration of Mechanical Ventilation

    Measured: Up to Day 29

  7. Mean Change from Baseline in Ordinal Scale

    Measured: Day 1 through Day 29

  8. Absolute Value Change from Baseline in Ordinal Scale

    Measured: Day 1 through Day 29

  9. Length of Time to Clinical Progression

    Measured: Up to Day 29

  10. Percentage of Participants in Each Severity Category of the 7-point Ordinal Scale

    Measured: Day 15 and Day 29

  11. Time to Sustained Normalization of Temperature

    Measured: Day 1 through Day 29

  12. Percentage of Participants with Normalization of Fever

    Measured: Day 1 through Day 29

  13. Number of Participants who Develop Acute Respiratory Distress Syndrome (ARDS)

    Measured: Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2020
  2. Study start2 Jun 2020
  3. Primary completion3 Mar 2021
  4. Study completion3 Mar 2021

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04432324
Sponsor's protocol ID
GC2004
Other IDs
2020-001696-32
Status last verified
Mar 2021
First submitted
12 Jun 2020
Last updated
10 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intravenous Immune Globulin and Standard Medical Treatment in people with COVID-19, run by Instituto Grifols, S.A. at 10 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 11 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 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 Participants Dying or Requiring ICU Admission (time frame: Up to Day 29). 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?

On the ClinicalTrials.gov record for NCT04432324.

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 10 Mar 2021.

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