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.
Biological: Anti-SARS-CoV-2 immunoglobulin
Treatment with Anti-SARS-CoV-2 immunoglobulin
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.