Anti SARS-CoV-2 gammaglobuli

Phase 1

Recruiting

• Conditions: Betacoronavirus; COVID-19; SARS-CoV2; Coronavirus Infections; SARS Virus; Coronaviridae Infections

• Registration Number: RPCEC00000379
• Lead Sponsor: AICA Laboratorories Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-30
• Study Completion: 2021-12-30
• Results First Posted: 2022-01-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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.

Exclusion Criteria

1. Ventilated
2. With acute and chronic kidney disease
3. Previous thromboembolic events
4. History of previous anaphylaxis
5. Previous history of adverse reaction to intravenous gamma globulin
6. Pregnant or lactating woman
7. Severe comorbidity: terminal cancer and severe heart disease.
8. Body Mass Index (BMI) = 30
9. With a diagnosis of selective IgA immunodeficiency
10. With autoimmune diseases
11. That they are using treatment with the anti-CD 6 monoclonal antibody Itolizumab
12. History of having received treatment with blood products one month before inclusion in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety: <br>1. Serious adverse events. Causation relationship (1. Possible, 2. Probable, 3. Definitive). Measurement time: 7 days after treatment. <br>Exploring the Effect: <br>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.<br>