Hyperimmune plasma
BiologicalPLASMA OF CONVALESCENT COVID-19
NCT Number: NCT04366245
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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Notify Me18 year–80 year
All sexes
Interventional
Phase 1 / Phase 2
Hospital U. Jerez de la Frontera, Jerez de la Frontera, Cádiz, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PLASMA OF CONVALESCENT COVID-19
Standard of care for SARS-CoV-2 infection
Time frame: 30 days after enrollment
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: Day +21 after randomization
Time frame: Day +21 after randomization
Time frame: Day +21 after randomization
IL-6> 80 pg / mL, D-dimer> 10 times, ferritin> 1000 ng / mL.
Time frame: Day +21 after randomization
Time frame: Days 14 and 28.
Time frame: Until day 28
Time frame: Day +21 after randomization.
IL-6> 80 pg / mL, D-dimer> 10 times, ferritin> 1000 ng / mL until the cure test.
Time frame: Day +21 after randomization
Time frame: On days 7 and 21
Time frame: Until day 21.
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.
Time frame: At baseline and on day 21
Time frame: At baseline and on days 3, 7 and 21
Time frame: Before infusion
Andalusian Network for Design and Translation of Advanced Therapies
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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