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

niversidad Católica de Murcia (UCAM)0 个研究点目标入组 100 人开始时间: 2020年7月22日最近更新: 2020年7月27日

试验速览

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•- 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.

发起方

niversidad Católica de Murcia (UCAM)