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Convalesscent PlasmaWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)

Name (Synonyms) Correlation
drug475 COVID-19 experience surveys Wiki 1.00

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D009202 Cardiomyopathies NIH 0.58

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0001638 Cardiomyopathy HPO 0.58

There is one clinical trial.

Clinical Trials

1 A Randomized, Prospective, Open Label Clinical Trial on the Use of Convalescent Plasma Compared to Best Supportive Care in Patients With Severe COVID-19

This is a randomized, prospective, multicenter, open label clinical trial of convalescent plasma compared to best supportive care for treatment of patients with severe COVID-19. The aim of the study is to explore the therapeutic effect of convalescent plasma transfusions on the survival and course of disease of patients with severe COVID-19. Convalescent plasma will be collected from recovered COVID-19 patients. Patients with severe COVID-19 will be randomly assigned to two groups. Patients in the treatment group will receive covalescent plasma (250 - 325 ml) on days 1, 3 and 5. Patients in the control group will receive best supportive care. Clinical condition in all patients will be evaluated on day 14. In case of progressive COVID-19 on day 14 compared to baseline, patients in the control group may be switched to treatment with convalescent plasma on days 15, 17 and 19. Fifty-three patients will be included in each group. Data of each patient will be collected until discharge but nor longer than day 60.

NCT04433910 COVID-19 Drug: Convalesscent Plasma

Primary Outcomes

Description: Dichotomous composite endpoint of survival and no longer fulfilling criteria of severe COVID-19. All criteria must be met in order to fulfil the primary endpoint.

Measure: Composite endpoint of survival and no longer fulfilling criteria of severe COVID-19.

Time: Day 21

Secondary Outcomes

Description: Time to clinical improvement (defined as time from randomization to an improvement of two points on the WHO R&D Blueprint seven-category ordinal scale for clinical improvement)(Key secondary endpoint)

Measure: Time to clinical improvement

Time: day 0 to discharge within a 60 day period

Measure: Frequency and severity of adverse events by CTCAE v5.0, (Key secondary endpoint)

Time: day 0 to discharge within a 60 day period

Measure: Case fatality rate

Time: on day 21, 35 and 60

Measure: Length of hospital stay Length of hospital stay (if applicable)

Time: day 0 to 60

Measure: Length of stay in ICU

Time: day 0 to 60

Measure: Duration of ventilation support / ECMO

Time: day 0 to 60

Measure: Time until negative SARS-CoV-2 PCR (nasopharyngeal sample)

Time: day 0 to 60

Description: Comorbidities will be assessed and correlated to clinical improvement (WHO scale), mortality, length of stay in ICU (days) and length of hospital stay (days)

Measure: Predictive value of comorbidities

Time: day 0 to 60

Description: Correlation of coagulation markers (D-Dimers, prothrombin time, Partial Thromboplastin Time, ATIII, Fibrinogen) with clinical improvement (WHO scale), mortality, length of stay in ICU (days) and length of hospital stay (days)

Measure: Predictive value of coagulation markers

Time: day 0 to 60

Description: Corelation of Inflammation (laboratory testing: CRP, IL-6, Ferritin, Blood cell Count) with clinical improvement (WHO scale), mortality, length of stay in ICU (days) and length of hospital stay (days)

Measure: Predictive value of inflamation

Time: day 0 to 60

Measure: Percentage of former COVID-19 patients willing to donate qualifying for plasma donation.

Time: through study completion, an average of 8 months

Measure: Amount of Plasma Units that could be collected for the clinical trial

Time: through study completion, an average of 8 months

Measure: Titer of anti-SARS-CoV-2 in transfused plasma units

Time: any plasmaphereseis, through study completion, an average of 8 months

Description: Anti-SARS-CoV-2-antibody titers will be correlated with age; gender; severity of COVID-19; interval between resolution of symptoms and plasmapheresis of plasma donors

Measure: Impact of donor characteristics on anti-SARS-CoV-2 humoral response

Time: up to 60 days

Measure: Course of anti-SARS-CoV-2 titer in both patient groups at different time points related to transfusion of convalescent plasma

Time: up to 60 days

Description: Correlation of antibody titers with: 1. "Survival and no longer fulfilling criteria of severe COVID-19"; 2. Change in WHO ordinal scale; 3. Time to clinical improvement; 4. Length of hospital stay; 5. Length of ICU stay; 6. Length of mechanical Ventilation or ECMO support.

Measure: Correlation of anti-SARS-CoV-2 titer in transfused plasma units and primary and key secondary outcomes.

Time: day 0 to 60

Description: Effect of timing of plasma transfusions on outcome: comparison of early treatment, i.e. day 1, 3 and 5 in convalescent plasma group vs. delayed treatment, i.e. day 15, 17, 19 in patients crossing over from control group due to progressive disease on day-14 assessment.

Measure: Effect of timing of plasma transfusions

Time: day 0 to 60

No related HPO nodes (Using clinical trials)