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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
PLASMA OF CONVALESCENT COVID-19
Standard of care for SARS-CoV-2 infection
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
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).
Time frame: 30 days after enrollment
Efficacy: Death from any cause
Time frame: Day +21 after randomization
Efficacy: Need for mechanical ventilation
Time frame: 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.
Time frame: 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
Time frame: Day +21 after randomization
Efficacy. Mortality on days 14 and 28.
Time frame: Days 14 and 28.
Efficacy: Proportion of patients who required mechanical ventilation
Time frame: Until day 28
Efficacy: Proportion of patients who develop analytical alterations.
IL-6\> 80 pg / mL, D-dimer\> 10 times, ferritin\> 1000 ng / mL until the cure test.
Time frame: Day +21 after randomization.
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Hospital U. Torrecárdenas
Almería, Spain
Hospital U. Puerta del Mar
Cadiz, 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
...and 4 more locations
Efficacy: Cure / clinical improvement (disappearance or improvement of signs and symptoms of COVID-19) in the cure test.
Time frame: Day +21 after randomization
Efficacy: PCR negative for SARS-CoV-2
Time frame: 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.
Time frame: Until day 21.
Efficacy: Duration of hospitalization (days)
Time frame: Until day 21.
Virology and immunological variables: Qualitative PCR for SARS-CoV-2 in naso-oropharyngeal exudate sample
Time frame: At baseline and on day 21
Virology and immunological variables: Total antibody quantification
Time frame: At baseline and on days 3, 7 and 21
Virology and immunological variables: Quantification of total antibodies in PC donors recovered from COVID-19.
Time frame: Before infusion