Clinical trial to evaluate the efficacy and safety of gammaglobulins in COVID-19 treatment

Double-blind randomized placebo-controlled clinical trial to evaluate the efficacy and safety of the use of intravenous gammaglobulins in the treatment of patients with COVID-19

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001890-56-ES

Enrollment

100

Registered

2020-07-22

Start date

2020-06-10

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with severe symptoms of COVID-19, a disease caused by infection with the SARS-CoV-2 virus.

Interventions

Trade Name: Flebogamma (Human normal immunoglobulin (IVIg)) One ml contains: Human normal immunoglobulin,100mg ((purity of at least 97% IgG) Pharmaceutical Form: Concentrate for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adults 18 years of age or over. - SARS-CoV-2 infection confirmed by PCR technique from samples of the nasopharynx and / or sputum and / or the upper respiratory tract. - Interval between the onset of symptoms and randomization greater than or equal to 5 days. The onset of symptoms is mainly based on fever. If there is no fever, cough or other related symptoms may be used. - Patients with a diagnosis of multilobar pneumonia attributed to SARS-Cov-2 infection and diagnosed by chest X-ray or CT. - At least one of the following conditions: respiratory distress, Respiratory Rate (RF) = 30 times / min; oxygen saturation = 90% at rest; PaO2 / FiO2 ratio = 300 mmHg; respiratory failure with a clinical situation that in clinical judgment requires mechanical ventilation; shock situation; requiring monitoring and ICU treatment due to the patient's clinical situation. - At least one of the following conditions: levels above the normal range ??in a peripheral blood sample of: Ferritin, D-Dimer, Procalcitonin and IL-6. - Signing the informed consent on a voluntary basis. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70

Exclusion criteria

Exclusion criteria: - There are other culture microbiological evidences, antigen study or serology that can explain pneumonia, which include, but are not limited to: influenza A virus, influenza B virus, bacterial pneumonia, fungal pneumonia or suspect a non-infectious process. - Allergy to intravenous immunoglobulin or its preparation components. - Patients with selective IgA, IgM or IgG deficiency or another condition that makes the patients unsuitable for study therapy. - Pregnant or lactating women. - That the investigators consider it inappropriate to clinical criteria and other circumstances in which the investigator determines that the patient is not suitable for the clinical trial.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy and safety of using intravenously administered gammaglobulin as treatment in patients with COVID-19.;Secondary Objective: To evaluate the impact of the treatment on the clinical situation of the patients and on the inflammation markers at the end of the study period.;Primary end point(s): 1. Mortality, that is, number of deaths.;Timepoint(s) of evaluation of this end point: End point 1: Between 0- and 28-days.	—

Measure

Time frame

Main Objective: To evaluate the efficacy and safety of using intravenously administered gammaglobulin as treatment in patients with COVID-19.;Secondary Objective: To evaluate the impact of the treatment on the clinical situation of the patients and on the inflammation markers at the end of the study period.;Primary end point(s): 1. Mortality, that is, number of deaths.;Timepoint(s) of evaluation of this end point: End point 1: Between 0- and 28-days.

—

Secondary

Measure	Time frame
Secondary end point(s): 2. Clinical improvement of 2 points or more, based on a 7-point scale. 3. Proportion of patients with negative RT-PCR results. 4. Duration, in days, of mechanical ventilation. 5. Duration, in days, of hospitalization, that is, days the patient stays in the hospital. 6. Duration, in days, of the stay in the Intensive Care Unit. 7. Changes in inflammation markers: Ferritin, D-Dimer, Procalcitonin, Interleukin-6. 8. Number of days of receiving the prescribed medication to treat COVID-19 infection (hydroxychloroquine, antivirals, steroids, immunomodulators, monoclonal antibodies and / or others). 9. Frequency of occurrence of adverse events, due or not to the intervention. 10. Frequency of occurrence of serious adverse events, due or not to the study intervention.;Timepoint(s) of evaluation of this end point: End point 2: At 7-, 14- and 28-days after randomization. End point 3: At 7-, 14- and 28-days after randomization. End point 4: Between 0- and 28-days. End point 5: Between 0- and 28-days. End point 6: Between 0- and 28-days. End point 7: At 7- and 14-days after randomization. End point 8: Between 0- and 28-days. End point 9: Between 0- and 28-days. End point 10: Between 0- and 28-days.	—

Measure

Time frame

Secondary end point(s): 2. Clinical improvement of 2 points or more, based on a 7-point scale. 3. Proportion of patients with negative RT-PCR results. 4. Duration, in days, of mechanical ventilation. 5. Duration, in days, of hospitalization, that is, days the patient stays in the hospital. 6. Duration, in days, of the stay in the Intensive Care Unit. 7. Changes in inflammation markers: Ferritin, D-Dimer, Procalcitonin, Interleukin-6. 8. Number of days of receiving the prescribed medication to treat COVID-19 infection (hydroxychloroquine, antivirals, steroids, immunomodulators, monoclonal antibodies and / or others). 9. Frequency of occurrence of adverse events, due or not to the intervention. 10. Frequency of occurrence of serious adverse events, due or not to the study intervention.;Timepoint(s) of evaluation of this end point: End point 2: At 7-, 14- and 28-days after randomization. End point 3: At 7-, 14- and 28-days after randomization. End point 4: Between 0- and 28-days. End point 5: Between 0- and 28-days. End point 6: Between 0- and 28-days. End point 7: At 7- and 14-days after randomization. End point 8: Between 0- and 28-days. End point 9: Between 0- and 28-days. End point 10: Between 0- and 28-days.

—

Countries

Spain

Contacts

Public ContactBioithas

Bioithas, S.L.

laura.navarro@bioithas.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026