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anti-SARS-CoV-2 convalescent plasmaWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)


Name (Synonyms) Correlation
drug455 COVID-19 Convalescent Plasma (CCP) Wiki 0.50
drug1961 QuadraMune(TM) Wiki 0.50
drug1780 Patients with the treatment agains COVID19 Wiki 0.50
drug1822 Placebo Wiki 0.03

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.06
D007239 Infection NIH 0.03

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There are 4 clinical trials

Clinical Trials


1 Pilot Study for Use of Convalescent Plasma Collected From Patients Recovered From COVID-19 Disease for Transfusion as an Empiric Treatment During the 2020 Pandemic at the University of Chicago Medical Center

The purpose of this study is to assess the feasibility of delivering anti-SARS-CoV-2 convalescent plasma to hospitalized patients with severe or life-threatening COVID-19. Beyond supportive care, there are currently no proven treatment options for coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19 and could be rapidly available when there are sufficient numbers of people who have recovered and can donate high titer neutralizing immunoglobulin-containing plasma. Hypothesis: Collecting and administering convalescent plasma requires a level of logistical coordination that is not available in all centers. Objective: To establish feasibility for a hospital-based integrated system to collect and administer convalescent plasma to patients with severe or life-threatening COVID-19.

NCT04340050 Coronavirus Biological: anti-SARS-CoV-2 convalescent plasma
MeSH:Coronavirus Infections

Primary Outcomes

Description: Feasibility will be measured by (number of donors from whom convalescent plasma is harvested/number of interested donors) and number of patients who receive convalescent plasma at day 28.

Measure: Feasibility of performing study pathway consisting of consenting convalescent donors, harvesting convalescent plasma, application for FDA eIND and administering convalescent plasma to the patients

Time: 28 days after plasma administration

Description: Levels of respiratory support will be graded (e.g. room air, high flow oxygen, intubation) to determine the change in type of respiratory support at 28 days.

Measure: Type of respiratory support

Time: 28 days after plasma administration

Secondary Outcomes

Description: This will be a continuous outcome defined by the amount of time between plasma administration and cardiac arrest.

Measure: Cardiac arrest

Time: 28 days after plasma administration

Description: This will be a continuous outcome defined by the amount of time between plasma administration and transfer to ICU.

Measure: Transfer to ICU

Time: 28 days

Description: This will be a binary outcome defined by the amount of time between plasma administration and mortality in the ICU.

Measure: ICU mortality

Time: 28 days

Description: This will be a continuous outcome defined by the amount of time between plasma administration and discharge from ICU. This will be treated as a time-to-event.

Measure: ICU length of stay

Time: 28 days

Description: This will be a binary outcome defined by the amount of time between plasma administration and in-hospital mortality.

Measure: Hospital mortality

Time: 28 days

Description: This will be a continuous outcome defined by the amount of time between plasma administration and discharge from hospital.

Measure: Hospital length of stay

Time: 28 days

Description: This will be a continuous outcome defined by the amount of time between plasma administration and the transition from mechanical ventilation to non-invasive respiratory support.

Measure: Ventilator-free days

Time: 28 days

Description: 28-Day Overall Survival is defined as the status of the patient at the end of 28 days, beginning from the time of plasma administration.

Measure: Overall survival (28-day mortality)

Time: 28 days

2 Anti COVID-19 Convalescent Plasma Therapy

Why is the research needed? The pandemic known as COVID-19 is now spreading across the world with currently (April 10, 2020) more than 1 115 530 active cases and 96 791 deaths. In most affected countries the current goal is to 'flatten the curve' of the epidemic since there is no health care system that is able to treat an extremely high volume of patients all at once. There is a need for immediately applicable treatments for the patients at highest risk, which gains time until targeted therapies become available. A key feature in the pathomechanism of the disease is that the virus elicits an immunological over-reaction in the human body termed 'cytokine storm'. In susceptible patients this hyper-inflammation itself is a significant burden and may even inhibit the body to generate antibodies against the virus in adequate quantities. Therefore, identifying the subset of patients with excess cytokine response and supplementing them with convalescent plasma from recovered donors may be a life-saving treatment option. What is our study about? In light of recent promising data on plasma therapy in the treatment of COVID-19 and other viral epidemics, there is a need for better understanding the cytokine response to the virus in order to better characterize the target population for convalescent plasma therapy. Our hypothesis is that convalescent plasma transfusion from healthy donors who recovered from SARS CoV-2 is able to reduce the cytokine storm in addition to replenish the patient's own antibodies in the acutely infected phase of the disease. A plasmapheresis donation of 400ml will be performed in subjects who recovered from COVID-19 and who are otherwise eligible for plasma donation. The sample will be tested for anti-SARS CoV-2 neutralizing antibody titers and those that reach the level of 1:320 will be processed for transfusion at the Hungarian National Transfusion Service. Recipients will be COVID-19 patients requiring hospitalization regardless of the severity of the disease or other co-morbidities. A blood-type matched transfusion of 200 ml convalescent plasma will be infused in a single sitting through an iv. infusion of 4 hours. Recipients will be followed up at days 1, 3,7,12, 17, 28 for clinical symptoms, antibody levels and cytokine response.

NCT04345679 COVID 19 Biological: anti-SARS-CoV-2 convalescent plasma

Primary Outcomes

Description: Copies of COVID-19 per ml

Measure: Changing of viral load of SARS-CoV2

Time: Day 1,3, 7, 12

Secondary Outcomes

Description: Immunoglobulin G COVID-19 antibodies Immunglobulin G antibody titer

Measure: Changes in immunglobulin G COVID-19 antibody titer

Time: 12 days

Measure: Changes at the cytokine pattern

Time: 12 days

Description: Proportion of patients with Intensive Care Unit Admission requirement

Measure: Intensive Care Unit Admission

Time: Day 7,12,28

Description: Days of Hospitalization

Measure: Length of hospital stay

Time: Day 7, 12, 28

Description: Days with mechanical ventilation

Measure: Duration of mechanical ventilation

Time: Day 7, 12, 28

Description: Clinical status assessed according to the World Health Organization guideline

Measure: Clinical Status

Time: Day 7, 12, 28

Description: Proportion of death patients at days

Measure: Mortality

Time: Day 7, 12, 28

3 An Open Label, Phase 2 Study Evaluating the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19 Infection

This is a Phase II study. This research study is being conducted to use convalescent donor plasma in seriously ill patients who have COVID-19.

NCT04354831 COVID-19 Biological: anti-SARS-CoV-2 convalescent plasma
MeSH:Infection

Primary Outcomes

Description: Overall mortality within 60 days

Measure: Overall Mortality within 60 days

Time: sixty days from infusion of plasma

Secondary Outcomes

Description: length of admission for COVID

Measure: Length of ICU stay during current admission for COVID

Time: Length of admission for COVID through study follow-up period, an average of 60 days

4 Use of COVID-19 Convalescent Plasma in the Patients Infected With COVID-19 (SARS-CoV-2) - Efficacy and Safety

Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection

NCT04397523 Convalescent Plasma COVID-19 SARS-CoV 2 Biological: anti-SARS-CoV-2 convalescent plasma

Primary Outcomes

Description: The total number of days patients required respiratory support.

Measure: Duration of oxygenation and ventilation support

Time: 28 days after transfusion or until hospital discharge (whichever comes first)

Description: Total number of days patients were admitted to the hospital.

Measure: Hospital length of stay (LOS)

Time: 28 days after transfusion or until hospital discharge (whichever comes first)

Description: Total number of subjects to be admitted to the ICU after the convalescent plasma transfusion.

Measure: ICU admission

Time: 28 days after transfusion or until hospital discharge (whichever comes first)

Description: Days without oxygenation support after receiving convalescent plasma

Measure: Ventilator free days

Time: 28 days after transfusion or until hospital discharge (whichever comes first)

Description: Cumulation incidence of serious adverse events during the study protocol

Measure: Incidence of serious adverse events

Time: 28 days after transfusion or until hospital discharge (whichever comes first)

Secondary Outcomes

Description: Type of supplemental oxygen support (e.g. nasal canula, high flow nasal canula, noninvasive ventilation, intubation and invasive mechanical ventilation, rescue ventilation)

Measure: Type of respiratory support

Time: 28 days after transfusion or until hospital discharge (whichever comes first)

Description: Number of participants with different clinical outcomes including death, critical illness and recovery

Measure: Number of participants with different clinical outcomes including death, critical illness and recovery

Time: 28 days after transfusion or until hospital discharge (whichever comes first)


No related HPO nodes (Using clinical trials)