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Phase I / II multicentre, randomized and controlled clinical trial to evaluate the efficacy of treatment with hyperimmune plasma obtained from convalescent antibodies of COVID-19 infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental |
| |
| Comparator | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperimmune plasma | Biological | PLASMA OF CONVALESCENT COVID-19 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of Adverse Events and Serious Adverse Events grade 3 and 4, related to the product under investigation or the administration procedure, graduated according to the common toxicity criteria scale (CTCAE). | Incidence of Adverse Events and Serious Adverse Events grade 3 and 4, related to the product under investigation or the administration procedure, graduated according to the common toxicity criteria scale (CTCAE). | 30 days after enrollment |
| Efficacy: Death from any cause | Day +21 after randomization | |
| Efficacy: Need for mechanical ventilation | Day +21 after randomization | |
| Efficacy: Any of the following analytical data after 72h of randomization. | IL-6> 80 pg / mL, D-dimer> 10 times, ferritin> 1000 ng / mL. | Day +21 after randomization |
| Efficacy: SOFA scale ≥ 3 after 72 hours of randomization or an increase of 2 points or more from the basal level | Day +21 after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy. Mortality on days 14 and 28. | Days 14 and 28. | |
| Efficacy: Proportion of patients who required mechanical ventilation | Until day 28 | |
| Efficacy: Proportion of patients who develop analytical alterations. |
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Inclusion Criteria:
Informed consent prior to performing procedures. the oral consent be accepted testified to prevent paper handling.
Patient of both sexes, and ≥18 years.
SARS-CoV-2 infection determined by PCR in a sample of naso-oropharyngeal exudate or other respiratory specimen or determination of specific positive IgM antibodies, in <72 hours before randomization.
Patients requiring hospitalization for pneumonia COVID-19 without need until randomization of mechanical ventilation (invasive or non-invasive), and at least one of the following:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital U. Jerez de la Frontera | Jerez de la Frontera | Cádiz | 11407 | Spain | ||
| Hospital U. Puerto Real |
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| Standard of care for SARS-CoV-2 infection |
| Drug |
Standard of care for SARS-CoV-2 infection |
|
IL-6> 80 pg / mL, D-dimer> 10 times, ferritin> 1000 ng / mL until the cure test. |
| Day +21 after randomization. |
| Efficacy: Cure / clinical improvement (disappearance or improvement of signs and symptoms of COVID-19) in the cure test. | Day +21 after randomization |
| Efficacy: PCR negative for SARS-CoV-2 | On days 7 and 21 |
| Efficacy: Proportion of patients requiring treatment. | Proportion of patients requiring treatment with Tocilizumab Sarilumab, Anakimra or other IL-6 or IL-1 antagonists, or corticosteroids at doses of methylprednisolone greater than 2 mg / Kg / day (or equivalent) and / or any investigational medication. | Until day 21. |
| Efficacy: Duration of hospitalization (days) | Until day 21. |
| Virology and immunological variables: Qualitative PCR for SARS-CoV-2 in naso-oropharyngeal exudate sample | At baseline and on day 21 |
| Virology and immunological variables: Total antibody quantification | At baseline and on days 3, 7 and 21 |
| Virology and immunological variables: Quantification of total antibodies in PC donors recovered from COVID-19. | Before infusion |
| Puerto Real |
| Cádiz |
| 11510 |
| Spain |
| Hospital Costa del Sol | Marbella | Málaga | 29603 | Spain |
| Hospital U. Torrecárdenas | Almería | 04009 | Spain |
| Hospital U. Puerta del Mar | Cadiz | 11009 | Spain |
| Hospital U. Virgen de las Nieves | Granada | 18014 | Spain |
| Hospital U. San Cecilio | Granada | 18016 | Spain |
| Hospital Juan Ramón Jiménez | Huelva | 21005 | Spain |
| Hospital Regional U. de Málaga | Málaga | 29010 | Spain |
| Hospital U. Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Unversitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Universitario Virgen del Rocío | Seville | 41013 | Spain |
| Hospital U. Nuestra Señora de Valme | Seville | 41014 | Spain |
| Hospital San Juan de Dios | Seville | 41930 | Spain |
| ID | Term |
|---|---|
| D000093522 | COVID-19 Serotherapy |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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