COVID-19 trials registries data warehouse

https://rpcec.sld.cu/en/trials/RPCEC00000379-En

Beatriz Amat Valdés

bsuatv@infomed.sld.cu

2021-06-30

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1. Severe patients over 19 years of age, with a confirmed diagnosis by PCR-RT of infection by the SARS-CoV-2 virus.2. Patients with less than 10 days of evolution since the onset of symptoms.3. Patient who gives his informed consent.

1. Ventilated2. With acute and chronic kidney disease3. Previous thromboembolic events4. History of previous anaphylaxis5. Previous history of adverse reaction to intravenous gamma globulin6. Pregnant or lactating woman7. Severe comorbidity: terminal cancer and severe heart disease.8. Body Mass Index (BMI) = 309. With a diagnosis of selective IgA immunodeficiency10. With autoimmune diseases11. That they are using treatment with the anti-CD 6 monoclonal antibody Itolizumab12. History of having received treatment with blood products one month before inclusion in the study.

2

AICA Laboratorories Company

19

100

Cuba

Severe disease at enrollment

6: Severe disease at enrollment

30

Safety: 1. Serious adverse events. Causation relationship (1. Possible; 2. Probable; 3. Definitive). Measurement time: 7 days after treatment. Exploring the Effect: 2. Antiviral and anti-inflammatory favorable response on the 7th day after the treatment The favorable response is measured if there is an increase in the Ct value; in the RT PCR and a decrease in the neutrophil/lymphocyte ratio; of C-reactive protein and D-Dimer). Measurement time: days 0; 3; 5 and 7 after treatment.

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 1

[{"arm_notes": "", "treatment_id": 537, "treatment_name": "Gammaglobulin", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]