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

Study Overview
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Brief Summary
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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.

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

Conditions
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Covid19

Intervention / Treatment
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* Biological: Anti-SARS-CoV-2 immunoglobulin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anti-SARS-CoV-2 immunoglobulin<br>Treatment with Anti-SARS-CoV-2 immunoglobulin | Biological: Anti-SARS-CoV-2 immunoglobulin<br>* Treatment with Anti-SARS-CoV-2 immunoglobulin<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse events related to the infusion of anti-SARS-CoV-2 immunoglobulin through CTCAE v4.0. |  | 28 days | 
| Clearence of viral RNA evaluated by RT-PCR |  | 72 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of viral load evaluated by area under the curve of RT-PCR values | Viral load reduction evaluated by area under the curve of RT-PCR values | Day 0, Day 3, Day 7 and Day 14 | 
| Length of hospital stay | number of days between admission and discharge | For as long as the duration of the hospital stay | 
| Orotracheal Intubation Rate | Number of patients who progressed to the use of invasive mechanical ventilation and require orotracheal intubation throughout hospitalization | 28 days | 
| Infusional reaction rate | number of patients who experienced adverse events after the immunoglobulin infusion | 28 days | 
| Mortality rate | number of deceased patients | 28 days | 
| Assessment of adverse events | Frequency of adverse events classified following CTCAE | 28 days | 
| Evaluation of clinical status | Results of a 7-point ordinal severity scale | Day 0, Day 14, Day 21 and Day 28 | 
| Modulation of serum and cellular inflammatory marker | Exploratory analysis of the variation of inflammatory markers by ELISA/Luminex and flow cytometry, compared to baseline levels | Day 0, Day 3 and Day 7. |