Clinical trial to evaluate the efficacy and safety of gammaglobulins in COVID-19 treatment
- Conditions
- Patients with severe symptoms of COVID-19, a disease caused by infection with the SARS-CoV-2 virus.Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001890-56-ES
- Lead Sponsor
- niversidad Católica de Murcia (UCAM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
- 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method