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convalescent plasmaWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (8)

Name (Synonyms) Correlation
drug1226 Interferon-β 1a Wiki 0.50
drug7 0.9% Saline Wiki 0.50
drug2355 Standards of Care Wiki 0.50
drug2592 Umifenovir Wiki 0.50
drug2436 TY027 Wiki 0.50
drug2965 prone position Wiki 0.35
drug2265 Single Dose of Hydroxychloroquine Wiki 0.35
drug1355 Lopinavir / Ritonavir Wiki 0.25

Correlated MeSH Terms (6)

Name (Synonyms) Correlation
D003289 Convalescence NIH 0.22
D018450 Disease Progression NIH 0.13
D018352 Coronavirus Infections NIH 0.06
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D012128 Respiratory Distress Syndrome, Adult NIH 0.04
D011014 Pneumonia NIH 0.03

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.03

There are 4 clinical trials

Clinical Trials

1 Experimental Use of Convalescent Plasma for Passive Immunization in Current COVID-19 Pandemic in Pakistan in 2020

Experimental Use of Convalescent Plasma of Passive Immunisation In Current COVID-19 Pandemic in Pakistan in 2020 Rationale & Objective: This study would help to gather real-life setting clinical data in local population, ultimately leading to increased evidence based management of the disease condition in the said population. Eligibility: 1. informed consent must have been obtained 2. confirmed COVID-19 cases confirmed by RT-PCR laboratory tests 3. moderately severe or severe life-threatening COVID-19 related features: a) Moderately Severe disease as defined by the following features: i) Shortness of breath, ii) respiratory rate ≥ 30/min, iii) arterial blood oxygen saturation ≤ 92%, iv) and/or lung infiltrates > 25% within 24 to 48 hours 67 b) Severe Life-threatening disease as defined by: i) respiratory failure, ii) shock, and/or § multiple organ dysfunction Exclusion Criteria: Allergy history of plasma, sodium citrate and methylene blue; 2. For patients with history of autoimmune system diseases or selective IgA deficiency, 3. the application of convalescent plasma should be evaluated cautiously by clinicians. 4. Patients having evidence of uncontrolled cytokine release syndrome leading to end-stage multiorgan failure. Methodology: Total sample size is n=2000. A case report form (CRF) will have to be generated for each corona virus patient at baseline and the completion of study endpoint (at the time of discharge and at 4 weeks after experimental treatment modality using convalescent plasma. - A unique identification number will be issued for each patient in this protocol. - This data will be recorded in the national database. Data sources & Analysis: Patient data originating from patient medical record and assessments (mentioned in table below) will be recorded in the study CRF. Safety data (AEs and SAEs) from any time point during the study will be recorded in the study CRF. All analyses will be performed by third party statistician on SPSS. For continuous variables, summary statistics included n (number of observations), mean, standard deviation, median, minimum and maximum values, as well as frequencies and percentages for categorical variables will be presented.

NCT04352751 Covid-19 Other: convalescent plasma

Primary Outcomes

Description: Improvement in disease severity will be regarded as a shift from Critical to Severe or from Severe to Mild disease category. The various disease categories are defined as following (17): Mild COVID-19, defined by the absence of features given in criteria for moderate and severe disease. Severe COVID-19, defined by the presence of any of the following features: i. Shortness of breath ii. Respiratory rate ≥ 30/min, iii. Arterial blood oxygen saturation ≤ 93%, iiii. Lung infiltrates > 50% within 24 to 48 hours c. Critical COVID-19, defined by the presence of any of the following features: i. Respiratory failure, ii. Shock iii. Multiple organ dysfunction

Measure: Change in COVID-19 severity status

Time: Up to 09 days

2 DETERMINATION OF THE DOSE AND EFFECTIVENESS OF CONVALESCENT PLASMA IN SEVERELY AND VERY SEVERELY ILL PATIENTS BY COVID-19

The present study will try to respond first in an initial phase, what is the minimum effective dose necessary of convalescent plasma for getting better in severly ill (not intubated) or very severely ill (intubated) patients. Once the dose will be determined by each type of patient group (severely ill vs. very severely ill) has been determined, phase 2 of the study will begin, where the safety and efficacy of the use of plasma will be evaluated based on clinical, imaging and laboratory criteria. So, our hypotheses are: 1. Is there a minimum effective dose to treat seriously ill patients with convalescent plasma with COVID-19? 2. the plasma dose with the minimum effective effect will improve the clinical, laboratory and clearance conditions of the presence of the virus in the severely ill patient?

NCT04356482 COVID-19 SARS SARS-CoV 2 Convalescence Plasma Doses Biological: convalescent plasma
MeSH:Convalescence

Primary Outcomes

Description: no fever, respiratory improvement and blood oxygenation (Sat02, Sat02 / Fi02), general laboratory improvement.

Measure: Clinical improvement

Time: day -1 to day +22

Description: before convalescent plasma infusion, the CT image will be compared and subsequently the evolution of images in the CT will be evaluated every 72 hours on 3 times .

Measure: improvement in tomographic image

Time: day -1 to day +12

Description: the patients will be evaluated on three occasions the positivity of the test (PCR-RT). If two of them are negative, it will be defined as a virus-free patient.

Measure: test positivity for COVID-19

Time: day +6 to day +12

Description: Patients will be evaluated for adverse events during the plasma infusion up to 30 days after that. Especially mild and severe allergic reactions (anaphylaxis), other issues like TRALI.

Measure: early and late complications associated to convalescent plasma

Time: day 0 to day +30

Secondary Outcomes

Description: days of stay at ICU will be evaluated

Measure: days at ICU

Time: day 0 to day +30

3 Phase 2b/3 Trial to Evaluate the Safety and Efficacy of Plasma Transfusion From Convalescent Patients With SARS-CoV-2 Infection on Severity and Mortality of COVID-19 in Hospitalized Patients.

This is a multicenter double blinded study to evaluate the efficacy and safety of convalescent plasma from COVID-19 recovered individuals to treat hospitalized patients with severe COVID-19 disease. The study will enroll 250 subjects who will be randomized 1:1 to receive convalescent plasma or normal saline solution in a blinded manner. The primary endpoint will be mortality and improvement on the 8 point WHO scale over 28 days. An interim analysis will be done when 24 patients have completed their follow up to assess safety and also to confirm or adjust the sample size and randomization strategy according to observed endpoints.

NCT04388410 COVID-19 Biological: convalescent plasma

Primary Outcomes

Description: Ordinal 8-point severity outcome scale: 1 Death, 2 Hospitalized, intubated and receiving mechanical ventilation and additional organ support (eg. renal replacement therapy, vasopressors, extracorporeal membrane oxygenation), 3 Hospitalized, intubated and receiving mechanical ventilation but no additional organ support, 4 Hospitalized receiving non-invasive ventilation of high-flow oxygen, 5 Hospitalized, receiving supplementary oxygen by mask or nasal prongs, 6 Hospitalized, no oxygen therapy needed, 7 Not-hospitalized (ambulatory) with limited activity, 8 Not-hospitalized (ambulatory) with no limitation of activities.

Measure: Severity and death

Time: 28 days

Description: Any unfavorable and unintended symptom or sign (including an abnormal laboratory finding) temporally associated with the study intervention and considered related to the intervention that require interruption of study treatment. Including but not limited to: Severe allergic reactions (rash and fever), transfusion-associated lung injury (TRALI), transfusion-associated circulatory overload (TACO), and other severe unexpected events

Measure: Adverse events that require study treatment interruption

Time: During the 28 day of follow up

Secondary Outcomes

Description: Time (in days) to improvement in at least two categories in the 8-point ordinal severity scale in comparison to baseline on admission to the study.

Measure: Time to clinical improvement

Time: 28 days

Description: Ordinal 8-point severity outcome scale: 1 Death, 2 Hospitalized, intubated and receiving mechanical ventilation and additional organ support (eg. renal replacement therapy, vasopressors, extracorporeal membrane oxygenation), 3 Hospitalized, intubated and receiving mechanical ventilation but no additional organ support, 4 Hospitalized receiving non-invasive ventilation of high-flow oxygen, 5 Hospitalized, receiving supplementary oxygen by mask or nasal prongs, 6 Hospitalized, no oxygen therapy needed, 7 Not-hospitalized (ambulatory) with limited activity, 8 Not-hospitalized (ambulatory) with no limitation of activities.

Measure: Severity and death

Time: Days 1, 3, 5, 7, 12, 14, and 21.

Description: Antibody titers on serum/plasma as long as the patient remains in the hospital.

Measure: Antibodies against SARS-CoV-2

Time: Days 0, 3, 7, 14, 21, 28

Description: Changes in SOFA scale during hospitalization compared to the baseline

Measure: Disease progression 1

Time: 28 days

Description: Changes in at least two categories in the 8-point ordinal severity scale in comparison to baseline on admission to the study

Measure: Disease progression 2

Time: Days 7,14, 21, 28

Description: Time (in hours) spent receiving invasive mechanical ventilation in those who enter the study on mechanical ventilation.

Measure: Time on mechanical ventilation

Time: 28 days

Description: Temperature >=38°C on at least one measurement during the day

Measure: Number of days with fever

Time: 28 days

Description: Any unfavorable and unintended symptom or sign (including an abnormal laboratory finding) temporally associated with the study intervention and considered related to the intervention.

Measure: Adverse events attributed to the study intervention

Time: 28 days

4 Treatment of Patients With COVID-19 With Convalescent Plasma Transfusion: a Multicenter, Open-labeled, Randomized and Controlled Study

The COVID-19 pandemic has been spreading continuously, and in Brazil, until May 31, 2020, there have been more than 450.000 cases with more than 28.000 deaths, with daily increases. The present study proposes to evaluate the efficacy and safety of convalescent plasma in treatment of severe cases of COVID-19 in a multicenter, randomized, open-label and controlled study

NCT04415086 COVID-19 Biological: convalescent plasma

Primary Outcomes

Description: clinical improvement is defined as the time from the randomization date until the decline of 2 categories on the ordinal scale of 10 categories or hospital discharge (whichever comes first)

Measure: Time elapsed until clinical improvement or hospital discharge

Time: Follow up until 28 days after transfusion

Secondary Outcomes

Description: incidence of acute adverse events possibly or definitively realted to convalescent plasma transfusion

Measure: acute adverse events

Time: Up to 12 hours after transfusion

Description: Evaluation according to an ordinal scale of 10 categories

Measure: Clinical Status

Time: "Day 7", "Day 14" and "Day 28"

Description: Duration of mechanical ventilation, length of hospital stay in survivors up to 28 days and time from the beginning of treatment to death

Measure: Duration of clinical events

Time: Up to 28 days

Description: Detection of SARS-CoV-2 in nasopharyngeal swab

Measure: SARS-CoV-2 in nasopharyngeal swab

Time: Days 0, 1, 3, 7, 14 and 28 after transfusion and control groups

Description: Specific IgG, IgM and IgA titers for SARS-CoV-2

Measure: IgG, IgM and IgA titers for SARS-CoV-2

Time: Days 0, 1, 3, 5, 7, 14 and 28 after transfusion and control groups

Description: Titers of neutralizing antibodies

Measure: Neutralizing antibodies

Time: 0,1,7 14 and 28 days after transfusion and control groups

No related HPO nodes (Using clinical trials)