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

D'Or Institute for Research and Education

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Covid19

Treatments

Biological: Anti-SARS-CoV-2 immunoglobulin

Study type

Interventional

Funder types

Other

Identifiers

NCT04573855

PCL04/2020

Details and patient eligibility

About

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.

Enrollment

41 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.