Patients with Mild to Moderate Coronavirus Disease (COVID-19) MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 23.0 Level: LLT Classification code 10053983 Term: Corona virus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Flebogamma 5% DIF
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human normal immunoglobulin (IVIg)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Concentration
Sponsors
Instituto Grifols, S.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Hospitalized male or female patient = 18 years of age at time of Screening who is being treated for COVID-19. 2.Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by qualitative PCR (reverse transcriptase [RT]-PCR), or other commercial or public health assay in any specimen 300 to = 400 mm Hg (ie, arterial oxygen in mm Hg divided by fraction inspired oxygen concentration [eg, 0.21 for room air]) 5.Any One of the following related to COVID-19: i. Ferritin > 400ng/mL, ii. LDH > 300 U/L, iii. D-Dimers > reference range, or iv. C-reactive protein (CRP) > 40 mg/L 6.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. Note: In the event that a subject is not be able to consent for himself/herself prior to initiation of any study procedures, a legal representative or a nearest relative or relative by marriage will provide oral informed consent on behalf of the subject. If the legal representative or a nearest relative or relative by marriage is quarantined because of COVID-19 emergency, informed consent will be provided orally by a phone call and documented in the subject’s medical notes. This will be recorded in the medical history with the following paragraph “I have explained to the patient [representative] the characteristics and objective of the study, its risks and potential benefits. I have been able to answer your questions and I affirm that this patient [representative] has given his oral consent ”. Subsequently, and when possible, the patient's written consent will be obtained (Ethics Committee approved version, which will be signed by the researcher and the patient). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1.Patient requires invasive mechanical ventilation or ICU admission 2.Clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the subject at undue medical risk. 3.The subject has had a known (documented) serious anaphylactic reaction to blood, any blood-derived or plasma product or commercial immunoglobulin. 4.Patient has known (documented) hereditary fructose intolerance (HFI) 5.A medical condition in which the infusion of additional fluid is contraindicated (eg, decompensated congestive heart failure or renal failure with fluid overload) 6.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 7.Subjects with known (documented) thrombotic complications to polyclonal IVIG therapy in the past 8.Subjects with current or prior (within the past 1 month) myocardial infarction, stroke, deep vein thrombosis, or thromboembolic event. 9.Patients with limitations of therapeutic effort (eg, ‘do not resuscitate’ status). 10.Female subjects 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. 11.Patients participating in another interventional clinical trial with investigational medical product or device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if high dose IVIG plus SMT can reduce the proportion of subjects 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 subjects with COVID-19.;Secondary Objective: To compare high dose IVIG plus SMT versus SMT alone with regard to clinical efficacy as assessed by clinical severity, duration of hospital stay, dependency on oxygen or new need for ventilatory support, clinical response criteria including National Early Warning Score (NEWS), and clinical status scale through Day 29 in hospitalized subjects with COVID-19.;Primary end point(s): The primary efficacy variable is the proportion of subjects dying or requiring ICU admission on or before Day 29 or who are dependent on high flow oxygen devices or invasive mechanical ventilation on Day 29.;Timepoint(s) of evaluation of this end point: through Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Assessment of Clinical Severity: Change in NEWS from baseline (Day 1 through Day 29) The NEWS has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness [Alert, Voice, Pain, Unresponsive]). •Time to clinical response: NEWS = 2 maintained for 24 hours, Day 1 through Day 29 •Time to hospital discharge: defined as duration of hospitalization from Day 1 of study •If admitted to ICU post randomization: Duration of ICU stay through Day 29 •Duration of any oxygen use Day 1 through Day 29 •If requiring mechanical ventilation post randomization: Duration mechanical ventilation through Day 29 •Absolute value and mean change from baseline in the Ordinal scale Day 1 through Day 29: The Ordinal scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities. •Proportion (percentage) of subjects in each severity category of the 7-point Ordinal scale at Day 15 and Day 29 •Time to sustained normalization of temperature and proportion of patients with normalization of fever at all time points, defined as temperature < 36.6 °C armpit, < 37.2 °C oral, or < 37.8 °C rectal sustained for at least 24 hours •Number of subjects who develop Acute Respiratory Distress Syndrome (ARDS) through Day 29 •Length of time to clinical progression through Day 29 (defined as the time to death, mechanical ventilation, or ICU admission);Timepoint(s) of evaluation of this end point: through Day 29 | — |
Countries
Spain
Contacts
Public ContactDepartment of Clinical Trials
Instituto Grifols, S.A
Outcome results
None listed