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Hyperimmune plasmaWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)


Name (Synonyms) Correlation
drug2328 Standard of care for SARS-CoV-2 infection Wiki 1.00

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D007239 Infection NIH 0.06

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 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

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.

NCT04366245 SARS-CoV 2 Biological: Hyperimmune plasma Drug: Standard of care for SARS-CoV-2 infection
MeSH:Infection

Primary Outcomes

Description: 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).

Measure: 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).

Time: 30 days after enrollment

Measure: Efficacy: Death from any cause

Time: Day +21 after randomization

Measure: Efficacy: Need for mechanical ventilation

Time: Day +21 after randomization

Description: IL-6> 80 pg / mL, D-dimer> 10 times, ferritin> 1000 ng / mL.

Measure: Efficacy: Any of the following analytical data after 72h of randomization.

Time: Day +21 after randomization

Measure: Efficacy: SOFA scale ≥ 3 after 72 hours of randomization or an increase of 2 points or more from the basal level

Time: Day +21 after randomization

Secondary Outcomes

Measure: Efficacy. Mortality on days 14 and 28.

Time: Days 14 and 28.

Measure: Efficacy: Proportion of patients who required mechanical ventilation

Time: Until day 28

Description: IL-6> 80 pg / mL, D-dimer> 10 times, ferritin> 1000 ng / mL until the cure test.

Measure: Efficacy: Proportion of patients who develop analytical alterations.

Time: Day +21 after randomization.

Measure: Efficacy: Cure / clinical improvement (disappearance or improvement of signs and symptoms of COVID-19) in the cure test.

Time: Day +21 after randomization

Measure: Efficacy: PCR negative for SARS-CoV-2

Time: On days 7 and 21

Description: 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.

Measure: Efficacy: Proportion of patients requiring treatment.

Time: Until day 21.

Measure: Efficacy: Duration of hospitalization (days)

Time: Until day 21.

Measure: Virology and immunological variables: Qualitative PCR for SARS-CoV-2 in naso-oropharyngeal exudate sample

Time: At baseline and on day 21

Measure: Virology and immunological variables: Total antibody quantification

Time: At baseline and on days 3, 7 and 21

Measure: Virology and immunological variables: Quantification of total antibodies in PC donors recovered from COVID-19.

Time: Before infusion


No related HPO nodes (Using clinical trials)