TREATMENT WITH ANTI-SARS-COV-2 IMMUNOGLOBULIN IN PATIENTS WITH COVID-19

TREATMENT WITH ANTI-SARS-COV-2 IMMUNOGLOBULIN IN PATIENTS WITH COVID-19: A PHASE I / II STUDY

A Phase I/II clinical trial for safety and efficacy evaluation of treatment with anti-SARS-CoV-2 equine immunoglobulin (F(ab')2) in hospitalized patients with COVID-19 not requiring of invasive ventilation support.

Inclusion Criteria:

• Inpatients diagnosed with COVID-19 by RT-PCR;
• Time between symptom onset and inclusion ≤ 10 days;
• Age ≥ 18 years and <75 years
• No indication of invasive ventilatory support at the time of randomization;
• Signature of the Informed Consent Form.

Exclusion Criteria:

• Pregnant or lactating women
• Severe comorbidity: Severe heart disease, severe COPD or O2-dependent COPD, terminal cancer.
• Any confirmed or suspected immunosuppressive or immunodeficiency state, including HIV (regardless of treatment, CD4 count or viral load status); asplenia; severe recurrent infections and chronic use (more than 14 days) of immunosuppressive medication in the last 6 months, except for topical steroids or short-term oral steroids (cycle lasting ≤14 days);
• History of anaphylaxis or severe allergic reaction;
• Previous use of any heterologous serum;
• Participation in trials of prophylactic drugs or vaccines for COVID-19;
• Administration of immunoglobulins and / or any blood products in the previous three months.