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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-SARS-CoV-2 immunoglobulin | Experimental | Treatment with Anti-SARS-CoV-2 immunoglobulin |
|
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-SARS-CoV-2 immunoglobulin | Biological | Treatment with Anti-SARS-CoV-2 immunoglobulin |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |