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Hyperimmune plasmaWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)


Name (Synonyms) Correlation
drug346 Hidroxicloroquina + Azitromicina o Lopinavir/ritonavir + Interferon β-1b + Hidroxicloroquina Wiki 1.00

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D007239 Infection NIH 0.08

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: Hidroxicloroquina + Azitromicina o Lopinavir/ritonavir + Interferon β-1b + Hidroxicloroquina
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> 40 pg / mL, D-dimer> 1500, ferritin> 1000ng / 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.

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> 40 pg / mL, D-dimer> 1500, ferritin> 1000ng / 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, 14 and 21

Measure: Efficacy: Proportion of patients who required treatment with Tocilizumab

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 14

Measure: Virology and immunological variables: Total antibody quantification

Time: At baseline and on days 3, 7, 10 (while hospitalization lasts), and on days 14 and 28 (if you can return to the clinic or are still hospitalized).

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)