Name (Synonyms) | Correlation | |
---|---|---|
drug542 | Global Longitudinal Strain Wiki | 0.30 |
drug1270 | Standard Care Therapy Wiki | 0.30 |
drug984 | Passed infection of SARS-CoV-2 Wiki | 0.30 |
drug1470 | Video-Based Wiki | 0.30 |
drug1610 | non Wiki | 0.30 |
drug1109 | Questionnaires for specific phobia Wiki | 0.30 |
drug1274 | Standard Plasma Wiki | 0.30 |
drug734 | Lactated ringer's solution or sterile saline Wiki | 0.30 |
drug1087 | Psycho-Social Questionnaire Wiki | 0.30 |
drug1366 | Telerehabilitation-Based Wiki | 0.30 |
drug1271 | Standard Donor Plasma Wiki | 0.30 |
Name (Synonyms) | Correlation | |
---|---|---|
D018376 | Cardiovascular Abnormalities NIH | 0.30 |
D002318 | Cardiovascular Diseases NIH | 0.22 |
D006330 | Heart Defects, Congenital NIH | 0.21 |
D009202 | Cardiomyopathies NIH | 0.21 |
D009205 | Myocarditis NIH | 0.17 |
D008173 | Lung Diseases, Obstructive NIH | 0.12 |
D008171 | Lung Diseases, NIH | 0.11 |
D004630 | Emergencies NIH | 0.10 |
D018352 | Coronavirus Infections NIH | 0.08 |
D011024 | Pneumonia, Viral NIH | 0.04 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.03 |
D011014 | Pneumonia NIH | 0.02 |
D007239 | Infection NIH | 0.02 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0001626 | Abnormality of the cardiovascular system HPO | 0.23 |
HP:0001638 | Cardiomyopathy HPO | 0.21 |
HP:0006536 | Obstructive lung disease HPO | 0.13 |
HP:0002088 | Abnormal lung morphology HPO | 0.12 |
HP:0002090 | Pneumonia HPO | 0.02 |
There are 11 clinical trials
Researchers are trying to assess the treatment potential and safety of anti-SARS-CoV-2 convalescent plasma in patients with acute respiratory symptoms with confirmed COVID-19.
Description: Change in RNA levels of SARS-CoV-2 from nasopharyngeal using RT-PCR (reverse transcriptase polymerase chain reaction) across time.
Measure: RNA in SARS-CoV-2 Time: Days 0, 1, 3, 7, 14, 28, 60 and 90 after transfusionDescription: Total number of subjects to be admitted to the ICU after the anti-SARS-CoV-2 convalescent plasma transfusion.
Measure: ICU Admissions Time: 90 days after transfusionDescription: Total number of subject deaths.
Measure: Hospital Mortality Time: 90 days after transfusionDescription: The total number of days subjects were admitted to the hospital.
Measure: Hospital Length of Stay (LOS) Time: 90 days after transfusionDescription: The type of supplemental oxygen support (e.g. nasal cannula, high flow nasal cannula, noninvasive ventilation, intubation and invasive mechanical ventilation, rescue ventilation) of the anti-SARS-CoV-2 convalescent plasma group across time.
Measure: Type of respiratory support Time: 90 days after transfusion or until hospital discharge (whichever comes first)Description: The total number of days subjects required respiratory support.
Measure: Duration of respiratory support Time: 90 days after transfusion or until hospital discharge (whichever comes first)Coronavirus disease 2019 (COVID-19) was recognized as a pandemic on March 11, 2020 by the World Health Organization. The virus that causes COVID-19 (SARS-CoV-2) is easily transmitted through person to person and there is still no specific approach against the disease and mortality rate in severe cases is also significant. Therefore, finding effective treatment for the mortality of these patients is very important. In this study the investigators aim to determine the effect of Convalescent Plasma on COVID-19 patients Outcome through a Clinical Trial
Description: Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.
Measure: Mortality changes in day 10 Time: 10 days after plasma transmissionDescription: Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.
Measure: Mortality changes in day 30 Time: 30 days after plasma transmissionDescription: Measurement of CRP
Measure: Changes of C-reactive protein Time: Day 1Description: Measurement of CRP
Measure: Changes of C-reactive protein Time: Day 3Description: Measurement of CRP
Measure: Changes of C-reactive protein Time: Day 7Description: Measurement of IL-6
Measure: Changes of Interleukin 6 Time: Day 1Description: Measurement of IL-6
Measure: Changes of Interleukin 6 Time: Day 3Description: Measurement of IL-6
Measure: Changes of Interleukin 6 Time: Day 7Description: Measurement of TNF-α
Measure: Changes of tumor necrosis factor-α Time: Day 1Description: Measurement of TNF-α
Measure: Changes of tumor necrosis factor-α Time: Day 3Description: Measurement of TNF-α
Measure: Changes of tumor necrosis factor-α Time: Day 7Description: Partial pressure of arterial oxygen/Percentage of inspired oxygen
Measure: Changes of PaO2/FiO2 Ratio Time: Day 1Description: Partial pressure of arterial oxygen/Percentage of inspired oxygen
Measure: Changes of PaO2/FiO2 Ratio Time: Day 3Description: Partial pressure of arterial oxygen/Percentage of inspired oxygen
Measure: Changes of PaO2/FiO2 Ratio Time: Day 7Description: Computed tomography Scan and Chest X-Ray
Measure: Radiological findings Time: Within 2 hours after admissionDescription: Computed tomography Scan and Chest X-Ray
Measure: Radiological findings Time: Day 14There is currently no specific vaccine or treatment to treat critically ill patients with COVID-19. Different therapies are still under investigation and are use in different health institutions, however, a significant proportion of patients do not respond to these treatments, so it is important to seek new treatments. One of these alternatives is the use of convalescent plasma. The investigator will use plasma obtained from convalescent individuals with proven novel SARS-CoV-2 virus infection, diagnosed with coronavirus-19-induced disease and symptom-free for a period of not less than 10 days since they recovered from the disease. This plasma will be infused in patients affected by the same virus, but who have developed respiratory complications that have not responded favorably to usual treatment such as chloroquine, hydroxychloroquine, azithromycin, and other antivirals. The investigator will evaluate the safety of this procedure by accounting for any adverse event.
Description: Identify possible adverse effects after the administration of convalescent plasma
Measure: Side effects Time: 14 daysDescription: Development of heart failure during convalescent plasma transfusion or after it.
Measure: Heart Failure Time: 14 daysDescription: Development of pulmonary edema during convalescent plasma transfusion or after it.
Measure: Pulmonary Edema Time: 14 daysDescription: Development of any allergic reaction during convalescent plasma transfusion or after it.
Measure: Allergic Reaction Time: 14 daysDescription: RT PCR SARS-CoV-2
Measure: Viral load of SARS-CoV-2 Time: 48 hrsDescription: RT PCR SARS-CoV-2
Measure: Viral load of SARS-CoV-2 Time: 14 daysThe purpose of this study is to collect blood from previously COVID-19 infected persons who have recovered and use it as a treatment for those who are currently sick with a severe or life-threatening COVID-19 infection.
Description: Mortality within 28 days
Measure: Mortality Time: 28 daysDescription: Reduction of Viral Load ]
Measure: Viral Load Time: 7 daysDescription: Change in Serum Antibody Titers
Measure: Serum Antibody Titers Time: 7 daysThe purpose of this study is to find out if transfusion of blood plasma containing antibodies against COVID-19 (anti-SARS-CoV-2), which were donated from a patient who recovered from COVID-19 infection, is safe and can treat COVID-19 in hospitalized patients. Antibodies are blood proteins produced by the body in response to a virus and can remain in the person's bloodstream (plasma) for a long time after they recover. Transferring plasma from a person who recovered from COVID-19 may help neutralize the virus in sick patients' blood, and/or reduce the chances of the infection getting worse.
Description: Number of days a patient is receiving mechanical invasive ventilation through 28 days post randomization. Patients who die during this time period are assigned 0 ventilator free days.
Measure: 28 day ventilator free days Time: 28 days post randomizationDescription: All cause mortality from randomization until 90 days post randomization
Measure: 90 day all-cause mortality Time: 90 daysThis study will evaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma (convalescent plasma) versus control (standard plasma) in patients with COVID-19 respiratory symptoms. This study will recruit patients who present for clinical evaluation in the emergency department (ED) but who do not require hospital admission. Disease progression due to COVID-19 will be assessed, which may include changes in symptom severity, return visit to the ED, or hospital admission.
Description: Progression of disease is defined as any of the following: Patient admitted to the hospital Patient seen in the emergency room (return visit after visit when enrollment takes place) Patient reports increased symptoms of 2 levels on the COVID Outpatient Ordinal Outcomes Scale over a 24 hour period Patient reports increased symptoms of 1 level on the COVID Outpatient Ordinal Outcomes Scale observed for a 48 hour period. COVID Outpatient Ordinal Outcomes Scale: Patient requires care in the hospital Patient requires care in the ED or urgent care Patient at home with symptoms rates as moderate (defined as fever, shortness of breath, abdominal pain) Patient at home with symptoms rated as mild (defined as afebrile, constitutional symptoms (flu-like illness) without shortness of breath) Patient in their usual state of health
Measure: Time to disease progression Time: 15 daysDescription: Categorical change in symptom severity rated on the COVID Outpatient Ordinal Outcomes Scale: Patient requires care in the hospital Patient requires care in the ED or urgent care Patient at home with symptoms rates as moderate (defined as fever, shortness of breath, abdominal pain) Patient at home with symptoms rated as mild (defined as afebrile, constitutional symptoms (flu-like illness) without shortness of breath) Patient in their usual state of health
Measure: Change in symptom severity over time Time: 15 daysThis is an expanded access treatment protocol to treat up to 100 patients with severe or life-threatening, laboratory confirmed COVID-19 with COVID-19 convalescent plasma.
This is a randomized, blinded phase 2 trial that will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms requiring oxygen supplementation.
Description: No clinical or virological evidence of infection Not hospitalized, no limitations on activities Not hospitalized, limitation on activities Hospitalized, not requiring supplemental oxygen Hospitalized, requiring supplemental oxygen Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, on invasive mechanical ventilation or ECMO Death
Measure: Percentage of subjects reporting each severity rating on WHO ordinal scale for clinical improvement Time: 14 days post randomizationDescription: No clinical or virological evidence of infection Not hospitalized, no limitations on activities Not hospitalized, limitation on activities Hospitalized, not requiring supplemental oxygen Hospitalized, requiring supplemental oxygen Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, on invasive mechanical ventilation or ECMO Death
Measure: Percentage of subjects reporting each severity rating on WHO ordinal scale for clinical improvement Time: 28 days post randomizationDescription: Anti-SARS-CoV-2 titers (IgM, IgG, IgA)
Measure: Comparison in Anti-SARS-CoV-2 antibody titers Time: 0, 1, 7, 14, 28, 90 days post randomizationDescription: SARS-CoV-2 PCR in nasopharyngeal swabs
Measure: Proportion positive in SARS-CoV-2 RNA Time: 0, 7, 14, 28 days post randomizationDescription: Rate of mortality
Measure: Mortality Time: 7, 14, 28 days post randomizationDescription: Percentage of patients requiring Intensive Care Unit admission
Measure: Rates of Intensive Care Unit admission Time: 7, 14, 28 days post randomizationDescription: Lymphocyte counts
Measure: Changes from baseline in lymphocyte Time: 0, 1, 3, 7, 14 days post randomizationDescription: Neutrophil counts
Measure: Changes from baseline in neutrophils Time: 0, 1, 3, 7, 14 days post randomizationDescription: D-dimer level
Measure: Changes from baseline in D-dimer Time: 0, 1, 3, 7, 14 days post randomizationDescription: Fibrinogen level
Measure: Changes from baseline in fibrinogen Time: 0, 1, 3, 7, 14 days post randomizationDescription: T cell subsets
Measure: Changes from baseline in T lymphocyte subsets Time: 0, 7, 28 days post randomizationDescription: B cell subsets
Measure: Changes from baseline in B lymphocyte subsets Time: 0, 1, 3, 7, 14 days post randomizationThe novel coronavirus disease (COVID-19), which began in Wuhan, China, in December 2019, has been declared to be a pandemic by the World Health Organization (WHO), Caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), COVID-19 has resulted in 1,781,127 cases and 108,994 deaths globally (till 12th April, 2020), affecting 199 countries and 2 international conveyances. US FDA has recently approved Convalescent Plasma from patients recovered from COVID 19 for the treatment of severe or life threatening COVID-19 infections. In a small case series, five critically ill COVID-19 patients with ARDS were treated with convalescent plasma containing neutralizing antibodies. Infusion of plasma was followed by improvement in clinical status in all five patients, with no deaths and the study reported that three patients were discharged, whilst two continued to be stable on mechanical ventilation. We designed this phase II, open label, randomized clinical trial with the primary objective to assess the safety and efficacy of the therapy in the second stage.
Description: Baseline data about the demography, clinical presentations, ongoing medical therapy, and clinical history of participants in both arms will be collected and compared. Response to convalescent plasma will be coded as a binary outcome - based on whether the composite primary end point is met or not. All the statistical tests will be done at 5% level of significance and SPSS21 will be used for calculations.
Measure: The primary outcome is a composite measure of the avoidance of - 1. Progression to severe ARDS (P/F ratio 100) and 2. All-cause Mortality at 28 days Time: depends on the total treatment time of the subjects within one year period of the trial.Description: Data from both arm will be collected and compared time to time
Measure: Time to symptom resolution-Fever,Shortness of Breath,Fatigue Time: one yearDescription: total time of stay at hospital for the treatment and cure will be calculated and compared of both the arms
Measure: Hospital length of stay Time: one yearDescription: sepsis-related organ failure assessment (SOFA) score will be calculated for both the arms and compared for the analysis.
Measure: Change in SOFA pre and post transfusion Time: one yearDescription: Most COVID patients admitted to intensive care require some form of respiratory support. Whether or not the plasma therapy decreases the duration of respiratory support and its comparison with the standard care therapy will be calculated.
Measure: Duration of respiratory support required a. Duration of Invasive Mechanical Ventilation b. Duration of Non-Invasive Time: one yearDescription: Comparison between group response rates will be analyzed by radiological imaging and reported.
Measure: Radiological improvement Time: one yearDescription: Adverse events associated with infusion of convalescent plasma will also be descriptively summarized and compared with the adverse events experienced by participants receiving standard of care.
Measure: Adverse events (AE) associated with transfusion Time: one yearDescription: Ct values from day 0, 1, 3 & 7 will be calculated by RT-PCR and compared to check the response of therapy on the viral load. All the statistical tests will be done at 5% level of significance and SPSS21 will be used for calculations.
Measure: To measure the change in RNA levels (Ct values) of SARS-CoV-2 from RT-PCR [Time Frame: Days 0, 1, 3, and 7 after transfusion] Time: one yearDescription: Bio-markers can play a role in understanding how existing drugs can be used to treat Covid-19. Hence, pre and post Plasma transfusion the level of bio-markers will be checked and compared.
Measure: Levels of bio-markers pre and post transfusion Time: one yearDescription: For critically ill subjects in both the arms the need of vasopressor will be compared. All these comparisons are for qualitative data and will be assessed for statistical significance by Fisher exact test in view of the small sample size.
Measure: Need of Vasopressor use Time: one yearThis protocol provides access to investigational convalescent plasma for patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. Following provision of informed consent, patients will be transfused with 1-2 units of ABO compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2 (as detailed in separate protocol). Safety information collected will include serious adverse events judged to be related to administration of convalescent plasma. Other information to be collected will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated), and survival to discharge from acute care facility.
Description: Percentage of patients who are consented and ultimately receive convalescent plasma transfusion.
Measure: Number of patients who receive COVID-19 convalescent plasma transfusions in acute care facilities infected with SARS-CoV-2 Time: 1 yearDescription: Adverse Events including transfusion reaction (fever, rash), transfusion related acute lung injury (TRALI), transfusion associated circulatory overload (TACO), and transfusion infection
Measure: Number and type of adverse events associated with COVID-19 convalescent plasma in patients with COVID-19 Time: 0, 1, 2, 3, 7, 14, 28, 60, and 90 daysDescription: Days of hospitalization
Measure: Length of hospital stay Time: 0, 1, 2, 3, 7, 14, 28, 60, and 90 daysDescription: Days of Intensive Care Unit management
Measure: Length of Intensive Care Unit stay Time: 0, 1, 2, 3, 7, 14, 28, 60, and 90 daysDescription: Days of intubation requirement
Measure: Length of intubation Time: 0, 1, 2, 3, 7, 14, 28, 60, and 90 daysDescription: Proportion of patients who are successfully discharged from acute care facility
Measure: Survival to discharge Time: 0, 1, 2, 3, 7, 14, 28, 60, and 90 daysDescription: Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Measure: Changes in complete blood count in patients after receiving convalescent plasma Time: 0 and 7 daysDescription: BMP tests include measures of glucose, calcium, sodium, potassium, bicarbonate, chloride, blood urea nitrogen, and creatinine. Changes of interest include those that are flagged as abnormal. Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Measure: Abnormal changes in Basic Metabolic Panel (BMP) measures in patients after receiving convalescent plasma Time: 0 and 7 daysDescription: Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Measure: Changes in C-Reactive Protein (CRP) in patients after receiving convalescent plasma Time: 0 and 7 daysDescription: Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Measure: Changes in d-dimer in patients after receiving convalescent plasma Time: 0 and 7 daysDescription: Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Measure: Changes in fibrinogen in patients after receiving convalescent plasma Time: 0 and 7 daysDescription: Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Measure: Changes in prothrombin time (PT) in patients after receiving convalescent plasma Time: 0 and 7 daysDescription: Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Measure: Changes in partial thromboplastin time (PTT) in patients after receiving convalescent plasma Time: 0 and 7 daysPurpose of Study • The purpose of this study to evaluate, the effectiveness of convalescent plasma in combatting the symptoms and effects of the coronavirus disease, COVID-19. Beyond supportive care, there are no proven treatment options for COVID-19.
Description: % patients who survived
Measure: Survival Rate Time: At 28 Days