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.
Biological: Hyperimmune plasma
PLASMA OF CONVALESCENT COVID-19
Drug: Standard of care for SARS-CoV-2 infection
Standard of care for SARS-CoV-2 infection
Inclusion Criteria:
1. Informed consent prior to performing procedures. the oral consent be accepted
testified to prevent paper handling.
2. Patient of both sexes, and ≥18 years.
3. 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.
4. 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:
- O2 saturation ≤ 94% in ambient air, or PaO2 / FiO2 ≤ 300 mm Hg.
- Age> 65 years.
- Presence of: high blood pressure, chronic heart failure, chronic obstructive
pulmonary disease, liver cirrhosis, or other chronic pulmonary and cardiovascular
diseases, diabetes, or obesity
Exclusion Criteria:
1. Requirement before randomization of mechanical ventilation (invasive or non-invasive).
2. Any of the following analytical data before randomization: IL-6> 80 pg / mL, D-dimer>
10 times ULN, ferritin> 1000ng / mL.
3. Participation in another clinical trial or experimental treatment for COVID-19.
4. In the opinion of the clinical team, progression to death or mechanical ventilation is
highly probable within 24 hours, regardless of treatment provision.
5. Incompatibility or allergy to the administration of human plasma.
6. Severe chronic kidney disease grade 4 or requiring dialysis (ie eGFR <30)
7. Pregnant, lactating, or fertile women who are not using an effective method of
contraception. It is considered a woman of childbearing age all women from 18 years
and up to a year after the last menstrual period in the case of menopausal women
Hospital U. Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain
Hospital U. Puerto Real
Puerto Real, Cádiz, Spain
Hospital Costa del Sol
Marbella, Málaga, Spain
Hospital U. Torrecárdenas
Almería, Spain
Hospital U. Puerta del Mar
Cádiz, Spain
Hospital U. Virgen de las Nieves
Granada, Spain
Hospital U. San Cecilio
Granada, Spain
Hospital Juan Ramón Jiménez
Huelva, Spain
Hospital Regional U. de Málaga
Málaga, Spain
Hospital U. Virgen de la Victoria
Málaga, Spain
Hospital Unversitario Virgen Macarena
Sevilla, Spain
Hospital Universitario Virgen del Rocío
Sevilla, Spain
Hospital U. Nuestra Señora de Valme
Sevilla, Spain
Hospital San Juan de Dios
Sevilla, Spain