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Sections: Correlations,
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Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug548 | Best Supportive Care Wiki | 0.22 |
| drug4142 | Umbilical cord derived mesenchymal stem cells Wiki | 0.19 |
| drug3704 | Standard Donor Plasma Wiki | 0.19 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug40 | 1: discontinuation of RAS blocker therapy Wiki | 0.19 |
| drug2289 | Masked Saline Placebo Wiki | 0.19 |
| drug2644 | Nuvastatic Wiki | 0.19 |
| drug2178 | Loss Frame and Fear Appeals Wiki | 0.19 |
| drug3647 | Small Gift Wiki | 0.19 |
| drug365 | Assessment of cardiovascular diseases and cardiovascular risk factors Wiki | 0.19 |
| drug1228 | Digital cardiac Counseling Wiki | 0.19 |
| drug2472 | NETosis markers Wiki | 0.19 |
| drug2890 | Phone-call screening and management by a medical student/general practitioner tandem Wiki | 0.19 |
| drug1621 | Gam-COVID-Vac Lyo Wiki | 0.19 |
| drug2348 | Mesenchymal stem cell therapy Wiki | 0.19 |
| drug3831 | Survey Group Wiki | 0.19 |
| drug1357 | Electrocardiogram, telemetry, echocardiogram, laboratory values Wiki | 0.19 |
| drug1015 | Computer task questionnaires Wiki | 0.19 |
| drug3702 | Standard Care Therapy Wiki | 0.19 |
| drug2221 | Lung ultrasound use in patients hospitalized with COVID Wiki | 0.19 |
| drug3988 | Therapeutic Plasma exchange Wiki | 0.19 |
| drug52 | 2: continuation of RAS blocker therapy Wiki | 0.19 |
| drug3510 | Saline solution Wiki | 0.13 |
| drug3036 | Postcard Wiki | 0.13 |
| drug933 | Clinical data Wiki | 0.11 |
| drug4401 | blood donation SMS Wiki | 0.11 |
| drug3728 | Standard of Care Wiki | 0.09 |
| drug3502 | Saline Wiki | 0.06 |
| drug1396 | Enoxaparin Wiki | 0.05 |
| drug3738 | Standard of care Wiki | 0.04 |
| drug3319 | Remdesivir Wiki | 0.04 |
| drug3192 | Questionnaire Wiki | 0.03 |
| drug4025 | Tocilizumab Wiki | 0.03 |
| drug2916 | Placebo Wiki | 0.02 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D002318 | Cardiovascular Diseases NIH | 0.46 |
| D015428 | Myocardial Reperfusion Injury NIH | 0.19 |
| D015427 | Reperfusion Injury NIH | 0.19 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D006973 | Hypertension NIH | 0.08 |
| D001523 | Mental Disorders NIH | 0.07 |
| D000066553 | Problem Behavior NIH | 0.07 |
| D007239 | Infection NIH | 0.06 |
| D006333 | Heart Failure NIH | 0.05 |
| D018352 | Coronavirus Infections NIH | 0.05 |
| D008173 | Lung Diseases, Obstructive NIH | 0.05 |
| D002908 | Chronic Disease NIH | 0.05 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.04 |
| D008171 | Lung Diseases, NIH | 0.04 |
| D014947 | Wounds and Injuries NIH | 0.03 |
| D001008 | Anxiety Disorders NIH | 0.03 |
| D016638 | Critical Illness NIH | 0.02 |
| D011024 | Pneumonia, Viral NIH | 0.02 |
| D003141 | Communicable Diseases NIH | 0.01 |
| D011014 | Pneumonia NIH | 0.01 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0001626 | Abnormality of the cardiovascular system HPO | 0.45 |
| HP:0000822 | Hypertension HPO | 0.08 |
| HP:0000708 | Behavioral abnormality HPO | 0.07 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0001635 | Congestive heart failure HPO | 0.05 |
| HP:0006536 | Pulmonary obstruction HPO | 0.05 |
| HP:0002088 | Abnormal lung morphology HPO | 0.04 |
| HP:0002090 | Pneumonia HPO | 0.01 |
Navigate: Correlations HPO
There are 28 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: Up to 28 daysDescription: Median Viral Load at Day 0, Day 3, Day 5, and Day 7 Plasma Viral Load was measured using a research-use only real-time reverse transcription polymerase chain reaction (rRT -PCR) method which targets two regions of the SARS-CoV-2 N gene using TaqMan chemistry. The limit of detection for this assay is 75 copies/mL (standard curve of 75 copies/mL to 10,000,000 copies/mL of in vitro transcribed RNA prepared from the full SARS-CoV-2 N gene).
Measure: Viral Load Time: Day 0, Day 3, Day 5, and Day 7Description: Median Serum Antibody Titers at Day 0, Day 3, Day 5 and Day 7 Serum Antibody titers were measured using chemiluminescent SARS-CoV-2 immunoglobulin G (IgG) assay from Diazyme (Poway, CA) Positive IgG serum value is > or = 1.0 arbitrary units/mL [AU/mL] (linear reportable range for IgG is 0.20 - 100.00 AU/mL)
Measure: Serum Antibody Titers Time: Day 0, Day 3, Day 5, and Day 7- This is a single arm phase IIa study of convalescent plasma for the treatment of individuals hospitalized with COVID-19 infection. - Subjects will be considered as having completed the study after 60 (+/- 3) days, unless consent withdrawal or death occurs first. - Interim analysis will be permitted as described in the statistical section 8. - The final analysis will be conducted once the last subject completes the day 60 visit or withdraws from the study.
Description: Mechanical ventilation rate at 7 days from starting treatment in hospitalized COVID-19 patients
Measure: For patients hospitalized for COVID-19 but not intubated Time: 7 DaysDescription: Mortality rate at 30 days from starting treatment for patients with COVID-19
Measure: Primary objective for patients with COVID-19 already intubated Time: 30 DaysDescription: The duration of hospitalization is defined as the time in days from the first day of hospitalized to the date of discharge or death. Patients who are not discharged, are alive and still in the hospital on the date of closing follow-up, or lost follow-up on the date of closing follow-up will be considered censored on that date.
Measure: Duration of hospitalization Time: 60 DaysDescription: The duration of mechanical ventilation is defined as the time in days from the first day of using mechanical ventilation to the last day of using mechanical ventilation. All evaluable patients will be included and no censoring for this analysis.
Measure: Duration of mechanical ventilation Time: 60 DaysDescription: The time to symptom resolution is defined as the time in days from new therapy initiation to the first documented symptom resolution as assessed by local site. Patients whose symptom are not resolved, who are dead, or lost follow-up on the designed follow-up date will be censored on that date.
Measure: Time to symptoms resolution Time: 60 DaysDescription: Overall survival will be defined as the time in days from study entry to death. Patients who are alive on the date of closing follow-up will be censored on that date.
Measure: Overall survival Time: 60 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 daysThe overarching goal of this project is to confirm or refute the role of passive immunization as a safe and efficacious therapy in preventing the progression from mild to severe/critical COVID-19 illness and to understand the immunologic kinetics of anti-SARS-CoV-2 antibodies after passive immunization.The primary objective is to determine the efficacy and safety of a single dose of convalescent plasma (CP) for preventing the progression from mild to severe COVID-19 illness. The secondary objective is to characterize the immunologic response to CP administration. This study will adults presenting to the emergency department (ED) with mild, symptomatic, laboratory-confirmed COVID-19 illness, who are at high risk for progression to severe/critical illness, but who are clinically stable for outpatient management at randomization.
Description: Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.
Measure: Number of patients with disease progression Time: 15 daysDescription: This scale was developed by a special World Health Organization (WHO) committee for quantifying COVID-19 illness severity. 8 = Death 7 = Hospitalized, intubated, mechanically ventilated and requiring additional organ support (pressors, renal replacement therapy) 6 = Hospitalized, intubated and mechanically ventilated 5 = Hospitalized on non-invasive ventilation or high flow nasal cannula 4 = Hospitalized on supplemental oxygen by mask or nasal prongs 3 = Hospitalized not on supplemental oxygen 2 = Not hospitalized with limitation in activity (continued symptoms) 1 = Not hospitalized without limitation in activity (no symptoms)
Measure: Worst severity rating on the WHO COVID Ordinal Scale for Clinical Improvement during the 30 days following randomization Time: 30 daysDescription: Time to disease progression on the COVID Outpatient Ordinal Outcome Scale censored at 15 days after randomization. Scale provides more granular detail for outpatients than the WHO scale (adapted from Harrell and Lindsell, 2020). Worsening of symptoms is defined as any subject admitted to the hospital (level 1), seen in the emergency room (level 2), a patient who reports increased symptoms of 2 levels on the scale over a 24 hour period, or a patient who reports increased symptoms of 1 level observed for a 48 hour period. COVID Outpatient Ordinal Outcomes Scale 1 = patient requires care in the hospital 2 = patient requires care in the ED or urgent care 3 = patient at home with symptoms rated as moderate (defined as fever, shortness of breath, abdominal pain) 4 = patient at home with symptoms rated as mild (defined as afebrile, constitutional symptoms (flu-like illness) without shortness 5 = patient in their usual state of health
Measure: Time to disease progression 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: Uninfected 0 Uninfected; no viral RNA detected Ambulatory 1 Asymptomatic; viral RNA detected 2 Symptomatic; Independent 3 Symptomatic; assistance needed Hospitalized: Mild disease 4 Hospitalized; no oxygen therapy 5 Hospitalized; oxygen by mask or nasal prongs Hospitalized: Severe disease 6 Hospitalized; oxygen by NIV or High flow 7 Intubation & Mechanical ventilation; pO2/FIO2 >/= 150 or SpO2/FIO2 >/=200 8 Mechanical ventilation pO2/FIO2 < 150 (SpO2/FIO2 <200) or vasopressors 9 Mechanical ventilation pO2/FIO2 < 150 and vasopressors, dialysis or ECMO Death 10 Dead
Measure: Score on the WHO 11-point ordinal scale for clinical improvement at 14 days Time: 14 days post randomizationDescription: Uninfected 0 Uninfected; no viral RNA detected Ambulatory 1 Asymptomatic; viral RNA detected 2 Symptomatic; Independent 3 Symptomatic; assistance needed Hospitalized: Mild disease 4 Hospitalized; no oxygen therapy 5 Hospitalized; oxygen by mask or nasal prongs Hospitalized: Severe disease 6 Hospitalized; oxygen by NIV or High flow 7 Intubation & Mechanical ventilation; pO2/FIO2 >/= 150 or SpO2/FIO2 >/=200 8 Mechanical ventilation pO2/FIO2 < 150 (SpO2/FIO2 <200) or vasopressors 9 Mechanical ventilation pO2/FIO2 < 150 and vasopressors, dialysis or ECMO Death 10 Dead
Measure: Score on the WHO 11-point ordinal scale for clinical improvement at 28 days 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: Number 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 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 DaysThe plan is to transfuse COVID-19 infected patients with convalescent plasma and observe whether this will result in a significant improvement in clinical outcome in comparison to historical experience.
Description: To estimate infection-related mortality rates
Measure: Arms 1 & 2: number of critical and severe COVID-19 infected patients who are transfused with convalescent plasma result in lower death rates than the reported fatality rate Time: 30 days after initial treatmentDescription: To estimate overall survival
Measure: Arms 1 & 2: number of critical and severe COVID-19 infected patients who survive the infection Time: 30 days after initial treatmentDescription: To estimate progression incidence rates
Measure: Arm 3: number of high risk COVID-19 infected patients who are transfused with convalescent plasma result in lower incidence of progression to severe or critical disease than the reported case rate Time: 30 days after initial treatmentDescription: To estimate the rate of infection among healthy persons exposed to COVID-19
Measure: Arm 4: number of health care providers who are at risk to exposure to COVID-19 who are transfused with convalescent plasma result in lower incidence of developing COVID-19 infection than the reported case rate Time: 30 days after initial treatmentThis is a multicenter, Phase 2 study, to assess the efficacy of the treatment with convalescent plasma in patients with severe COVID-19 infection.
Description: The primary endpoint of this trial is the survival on day 21. The primary endpoint, as a dichotomous composite of survival (yes/no) and no longer fulfilling criteria of severe COVID-19, will be analyzed according their classification. Specifically, categorical variables will be analyzed by means of absolute and relative frequencies, and all continuous variables will be described using arithmetic mean, standard deviation, median, quartiles. Also, geometric means, variance and 95% confidence intervals (CI), will be calculated for all pharmacokinetics parameters.
Measure: Survival Time: Day 21Description: The primary endpoint of this trial is the survival on day 35.
Measure: Survival Time: Day 35Description: The primary endpoint of this trial is the survival on day 60.
Measure: Survival Time: Day 60Description: The secondary endpoint of this trial is that no longer fulfilling criteria of severe COVID-19 within 21 days after inclusion. This will be assessed on the basis of respiratory rate and ventilation support.
Measure: Clinical improvement ie percentage of patients not fulfilling the criteria for severe disease Time: Day 21Currently, no effective treatments are available for the COVID-19. Scientists and Researchers are working on many aspects of treatment options for the development of vaccination and medication to combat this life-threatening problem. Convalescent plasma from recovered COVID-19 patients contains antibodies against COVID-19 which may be beneficial to severely sick COVID-19 patients. Investigator have recently concluded a pilot phase II open-label RCT on the efficacy of convalescent plasma in severe COVID 19 patients in which encouraging results were seen. Investigator plan to further study the efficacy and safety of convalescent plasma in COVID-19 severely sick patients through an RCT. Investigator will collect up to 500 ml Convalescent Plasma from the COVID-19 recovered persons after 14 days of clinical recovery with two consecutive SARS CoV-2 negative tests by PCR at least 24 hours apart. This plasma will be tested and frozen and stored. On requisition it will be thawed and sent to the treating center. Two doses of 250 ml convalescent plasma each will be transfused on two consecutive days to patients who fit the eligibility criteria (Severely sick COVID-19 patients) and are randomized to the convalescent plasma group along with the standard of care and the other group will receive standard of care alone. Data will be collected to study the benefits and adverse events related to convalescent plasma transfusion.
Description: The six-point scale is as follows: death=6; hospital admission for extracorporeal membrane oxygenation or mechanical ventilation=5; hospital admission for non-invasive ventilation or high-flow oxygen therapy=4; hospital admission for oxygen therapy (but not requiring high-flow or non-invasive ventilation)=3; hospital admission but not requiring oxygen therapy=2; discharged or having reached discharge criteria (defined as clinical recovery-ie, normalization of pyrexia, respiratory rate 94% on room air, and relief of cough, all maintained for at least 72 h)=1.
Measure: Efficacy of convalescent plasma in severe COVID 19 patients in time to clinical improvement (Clinical improvement: Reduction of two points in ordinal scale or live discharge from the intensive care unit, whichever is earlier) Time: Day 28Description: IgG Titres against S1, RBD antigen, and SARS CoV2 neutralizing antibody titres
Measure: Presence of antibodies against SARS-CoV-2 in serum after plasma administration Time: Day 0Description: IgG Titres against S1, RBD antigen, and SARS CoV2 neutralizing antibody titres
Measure: Presence of antibodies against SARS-CoV-2 in serum after plasma administration Time: Day 3Description: IgG Titres against S1, RBD antigen, and SARS CoV2 neutralizing antibody titres
Measure: Presence of antibodies against SARS-CoV-2 in serum after plasma administration Time: Day 7Description: IgG Titres against S1, RBD antigen, and SARS CoV2 neutralizing antibody titres
Measure: Presence of antibodies against SARS-CoV-2 in serum after plasma administration Time: Day 14Description: IgG Titres against S1, RBD antigen, and SARS CoV2 neutralizing antibody titres
Measure: Presence of antibodies against SARS-CoV-2 in serum after plasma administration Time: Day 21Description: IgG Titres against S1, RBD antigen, and SARS CoV2 neutralizing antibody titres
Measure: Presence of antibodies against SARS-CoV-2 in serum after plasma administration Time: Day 28Description: Serum ferritin
Measure: Change in acute phase reactants in both groups Time: Day 28This a phase II, proof-of-concept study. In the present study, we investigate if the administration of blood-plasma from patients recovered from COVID-19, could be effective to treat patients who are severely ill because of a COVID-19 infection. The general idea behind the transfusion, is that plasma of recovered patients contains antibodies that could eliminate the novel coronavirus causing COVID-19, and lead to a less severe course of the disease, or a faster healing. Simply put, in this study we would like to investigate whether 'borrowed immunity' from a person who has cured from this disease, could be applied to cure other patients more rapidly.
Description: Primary outcome of the study is the number of patients alive without mechanical ventilation at day 15 after hospitalization.
Measure: Patients requiring mechanical ventilation or death Time: No mechanical ventilation at day 15 after hospitalization.Description: 0. Uninfected. Non viral RNA detected Ambulatory, Asymptomatic, viral RNA detected Ambulatory, Symptomatic, Independent Ambulatory, Symptomatic, Assistance needed Hospitalized, mild disease, No oxygen therapy needed Hospitalized, mild disease, Oxygen by mask of nasal prongs Hospitalized, severe disease, Oxygen by NIV or High flow Hospitalized, severe disease, Intubation and mechanical ventilation (pO2/FiO2>=150 OR SpO2/FIO2>=200) Hospitalized, severe disease, Mechanical ventilation (pO2/FiO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min) Hospitalized, severe disease, Mechanical ventilation pO2/FiO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO Death, Dead
Measure: Clinical status of subject at day 15 and day 30 (on a 10-point "WHO progression" ordinal scale) Time: day 15 and day 30This is an open label pilot study designed to provide access to treatment with investigational convalescent plasma and assess the relationship between NAb titers in the investigational convalescent plasma compared to changes in NAb levels in the recipient in hospitalized patients with COVID-19.
Description: To provide access to treatment with investigational convalescent plasma and measure NAb titers in an aliquot of the CP administered, to measure the volume of CP administered, and determine whether there is a correlation between the NAb dose titer in the CP and change or lack of change when comparing pre-treatment and day one NAb titers to inpatients with documented COIVD-19 infection
Measure: Correlation between the NAb dose titer in the convalescent plasma and change or lack of change when comparing pre-treatment and day one NAb titers to inpatients with documented COIVD-19 infection Time: 14 daysDescription: To evaluate the safety of convalescent plasma (CP) administration as determined by rapid deterioration of respiratory or clinical status on transfusion of SARS-CoV-2 convalescent plasma
Measure: Rapid deterioration as evidenced by increase in ordinal or news score within 4 hours of transfusion Time: 14 daysDescription: To evaluate number of participants with clearance of viral shedding of SARSCoV-2 in nasopharyngeal or nasal samples on days 3, 7, and 14 after CP transfusion.
Measure: Number of participants with clearance of viral shedding of SARSCoV-2 in nasopharyngeal or nasal samples Time: 14 days- This clinical trial proposal is based on the FDA protocol for emergency use of convalescent plasma for treatment of COVID-19 cases, and on the WHO guidelines for use of convalescent plasma in other infectious diseases. - This Clinical trial is to be applied in Cairo University quarantine hospital. The collection, testing and storage of convalescent plasma will be done inside CUH main blood bank. The concept of this clinical trial is built on the collection of convalescent plasma from individuals who had recovered from documented infection with SARS-CoV-2, to be used for patients with- or at high risk of progression to- severe/life-threatening clinical conditions due to SARS-CoV-2 infection. An informed consent is required to join this clinical trial; patients will be transfused with one or two units of ABO compatible convalescent plasma. Those patients will be followed up and the clinical and laboratory data will be compiled, including adverse events related to the administration of convalescent plasma (CP). Other data to be collected retrospectively will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated, and survival till discharge from an acute care facility).
Description: Decrease of hospital days of safety until discharge
Measure: Duration of hospitalization/Recovery status Time: 2-3 weeksThe purpose of this program is to see if giving convalescent plasma to individuals who test positive for COVID-19 may reduce their symptoms and help minimize complications from the illness.
- This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications. - Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first. - Subjects will be randomized to receiving convalescent plasma or best supportive care. - Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease. - The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study.
Description: The hospitalization rate will be summarized by frequency (%) and compared between the Treatment and Control arms by Mantel-Haenszel test.
Measure: Hospitalization Rate Time: 10 DaysDescription: The time to symptoms resolution is defined as the time in days from therapies initiation to the first documented symptoms resolution as assessed by a local site. Patients whose symptoms are not resolved, or result in death, or lost follow-up on the designed follow-up date, will be censored on that date.
Measure: Time to symptoms resolution Time: 2 MonthsDescription: Overall survival (OS) will be defined as the time in days from study entry to death. Patients who are alive on the date of closing follow-up will be censored on that date.
Measure: Overall survival Time: 2 MonthsDescription: Univariate test will be performed in terms of identifying the association between exploratory objective and the hospitalization rate, Mantel-Haenszel test for categorical variables, and t-test or its non-parametric version for the continuous variables based on the normalized of the data.
Measure: Plasma product's cytokine level assessment Time: Day 0Description: Safety assessment will be performed on infusion day for the Treatment group (immediately post infusion), and for all patients on randomization day +3 and +7 days (by telephone, closest business day is acceptable), +2 weeks (+/- 3 days), +4 weeks (+/- 3 days).
Measure: Rates of adverse events associated with convalescent plasma infusion. Time: Day 3 and 7, Weeks 2 and 4This expanded access program will provide access to investigational convalescent plasma for patients at Hackensack University Medical Center 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.
Trial design. Randomized, double-blind, placebo-controlled trial in a catchment population of 2,020,860 age-appropriate subjects in the state of Buenos Aires and 235,000 in the city of Buenos Aires. Institutions. Hospitals San Juan de Dios, Simplemente Evita, Dr. Carlos Bocalandro, Evita Pueblo, Sanatorio Antartida, Hospital Central de San Isidro, Clinica Olivos in the state of Buenos Aires with 38 regional and town hospitals acting as referral centers, and Hospital Militar Central, Sanatorio de Los Arcos, Hospital Universitario CEMIC, Sanatorio Sagrado Corazon, Sanatorio Finochietto, Sanatorio Anchorena, Centro Gallego, and in the city of Buenos Aires in Argentina. Study population. Subjects >= 75 years of age irrespective of presenting comorbidities or between 65-74 years of age with at least one comorbidity (hypertension, diabetes, obesity, chronic renal failure, and COPD) who experience the following signs and symptoms for less than 48 hours at the time of screening for SARS CoV2 by RT-PCR: (a) a temperature >=37.5°C and/or unexplained sweating and/or chills and (b) at least one of the following: dry cough, dyspnea, fatigue, myalgia, anorexia, sore throat, loss of taste and/or smell, rhinorrhea. Subjects consenting to screening will be tested by reverse-transcriptase-polymerase-chain-reaction (RT-PCR) for SARS-CoV-2 in a nasopharyngeal and an oropharyngeal swab and invited to participate when RNA for the virus is detected. Intervention. Eligible, consenting patients will be randomized using an electronic system to receive 250 ml of convalescent plasma with an IgG titer against SARS-CoV2 spike (S) protein >1:1,000 (COVIDAR IgG, Insituto Leloir, Argentina) or placebo (normal saline 0.9%) administered in a 1:1 ratio. Both treatment and placebo will be concealed using dark bags and tape to cover the infusion line. Treatment will be administered <72 hours from initiation of symptoms. Subjects will be monitored for 12 hours after treatment for adverse events. Clinical and laboratory monitoring. All participating subjects will be admitted to the hospital upon enrollment. Twenty-four hours after completing the infusion, a sample of venous blood (5 ml) will be obtained from all participants to measure anti-S IgG SARS-CoV2 in serum (COVIDAR IgG, Leloir) and preserved at -20°C until completion of the study. Patient evolution will be assessed daily by study physicians during hospitalization until day 25 and/or at home until day 15, in the event of earlier discharge from the hospital. Study physicians will use predesigned questionnaires to collect clinical information. An Independent Data Safety Monitoring Board (DSMB) will supervise participating subjects during the study. Endpoints. The primary endpoint of the trial is development of severe respiratory disease defined as a respiratory rate (RR)>30 and/or an O2 sat<93% when breathing room air determined using a predefined protocol. Three other clinical endpoints include (a) life threatening respiratory disease, defined as need for 100% oxygen supplementation and/or non-invasive or invasive ventilation and/or admission to intensive care; (b) critical systemic illness, defined as respiratory failure (PaO2/FiO2 ≤ 200 mm Hg) and/or shock and/or multiorganic distress syndrome; and (c) death. Statistical analysis. The study is designed to have one interim analysis when the outcome results for 50% of the subjects is obtained. The minimally clinically important difference was set at a 40% relative reduction for an expected outcome rate of 50% in the control group reduced to 30% in the intervention group. A total sample size of 210 subjects (105 per trial arm) was estimated to have 80% power at a significance level (alpha) of 0.05 using a two-sided z-test with continuity correction. Ethical considerations. The trial has been approved by the institutional review boards of participating institutions and the Central Ethics Committee of the state of Buenos Aires. The study will be conducted in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines of the International Conference on Harmonization. Written informed consent will be obtained from all patients for screening and enrollment.
Beyond supportive care, there are currently no proven treatment options for coronavirus disease (COVID-19) and related pneumonia, caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).Investigators have seen recently from experience in Western countries with best health care systems that pandemics cannot be managed in hospitals. Investigators have seen ICUs crowded to capacity, healthcare workers being exposed and going to quarantine or dying after exposure to large doses of viral inoculums. Investigators recommend that institutions should register for Clinical trials and consider emergency use of TPE. In Pandemics, time is of essence to avoid mortality by intervening early with available evidence, preferably as part of clinical trial.Since the outbreak of corona virus disease (COVID-19), main treatment modalities have been antivirals, interferons, glucocorticoids, anti-coagulants and supportive treatment in addition to traditional Chinese medicine. There are also clinical trials exploring hydroxyquinoline / chloroquine sulphate, azithromycin, immunoglobulins, Vitamin-C, washed microbiota, nebulized interferon, teicoplanin as well as Mesenchymal stem cells. However, most of these trials were small and remain in the experimental phase with currently no effective / specific antiviral with robust scientific evidence as regards the mortality reduction in COVID-19.In an attempt to treat COVID-19, investigator will use different investigational treatment either alone or in combination to see mortality and morbidity benefit on the basis of limitted evidence available so far. These investigational modalities include Therapeutic plasma exchange (TPE), Convalescent Plasma (CP), Remdesivir, Tocilizumab and Mesenchymal stem cell (MSC) therapy in addition to standard supportive treatment.
Description: death or recovery
Measure: survival Time: 28 daysDescription: duration in days
Measure: duration of hospitalization Time: 28 daysDescription: duration in days to normalize symptoms and laboratory parameters
Measure: Time to resolution of cytokine release storm Time: 28 daysDescription: Time in days to turn PCR negative
Measure: Time of viral clearance Time: 45 daysDescription: incidence of Post Covid lung fibrosis
Measure: Complications Time: 90 daysThis study proposes to evaluate the therapeutic efficacy, immunologic effects and normalization of laboratory parameters for patients at high risk for mortality when infected by SARS-CoV-2 (COVID-19) when administered one unit (approximately 200 mL) of convalescent plasma administered over a period of one hour. Following administration of the convalescent plasma, physical exam/clinical assessment information is collected daily and routine lab result data is collected every three days.
Description: Measured by respiratory rate >30/min, blood oxygen saturation <93%, partial pressure of arterial oxygen to fraction of inspired oxygen ration <300 and received a medical diagnosis of respiratory failure, septic shock or multiple
Measure: Determine the therapeutic efficacy (response rate) of convalescent plasma infusion in patients at high risk for mortality when infected by SARS-CoV-2 (COVID-19). Time: Through study completion, an average of 30 daysDescription: SARS-CoV-2 Ag levels through RT-PCR
Measure: Determine the immunologic effects of convalescent plasma infusion Time: Through study completion, an average of 14 daysDescription: Measure normalization of laboratory parameters for risk
Measure: Absolute lymphocyte count (10*3/uL) Time: Through study completion, an average of 14 daysDescription: Measure normalization of laboratory parameters for risk
Measure: reatinine kinase (mg/dL) Time: Through study completion, an average of 14 daysDescription: Measure normalization of laboratory parameters for risk
Measure: C-reactive protein (mg/dl) Time: Through study completion, an average of 14 daysDescription: Measure normalization of laboratory parameters for risk
Measure: D-Dimer (ng/ml FEU) Time: Through study completion, an average of 14 daysDescription: Measure normalization of laboratory parameters for risk
Measure: Interleukin-6 (pg/ml) Time: Through study completion, an average of 14 daysDescription: Measure normalization of laboratory parameters for risk
Measure: Ferritin (ng/mL) Time: Through study completion, an average of 14 daysThe purpose of this study is to determine if treatment with convalescent plasma improves the clinical outcomes of Veterans who are hospitalized and require supplemental oxygen due to COVID-19.
Description: Respiratory failure is defined by requiring mechanical ventilation, with or without endotracheal intubations, or extra-corporeal membrane oxygenation.
Measure: Proportion of participants developing acute hypoxemic respiratory failure or all-cause death Time: Day 1 through Day 28Description: Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
Measure: Time (in days) to recovery Time: Day 1 through Day 28Description: Defined as the first day on which the subject died from any cause or had respiratory failure. Respiratory failure is defined by requiring mechanical ventilation, with or without endotracheal intubations, or extra-corporeal membrane oxygenation.
Measure: Time (in days) to death or respiratory failure Time: Day 1 through Day 28Description: Defined as the proportion of subjects who died from any cause or had respiratory failure, or who required humidified heater high-flow cannula (HHHFNC). Respiratory failure is defined by requiring mechanical ventilation, with or without endotracheal intubations, or extra-corporeal membrane oxygenation.
Measure: Proportion of patients who died from any cause, had respiratory failure, or required humidified heated high-flow nasal cannula (HHHFNC) at 15 Lpm Time: Day 1 through Day 28Description: Time to death or respiratory failure is defined as the first day on which the subject died from any cause or had respiratory failure (defined above), or who required HHHFNC at 15 Lpm.
Measure: Time (in days) to death or respiratory failure or HHHFNC at 15 Lpm Time: Day 1 through Day 28Description: Date and cause of death (if applicable)
Measure: Subject 28-day all-cause mortality Time: Day 1 through Day 28Description: Modified WHO 8-point Ordinal Scale for Clinical Improvement. The scale is as follows: 0) No clinical or Virologic evidence of infection; 1) No limitation of activity; 2) Limitation of activity and/or home oxygen; 3) Hospitalized, no oxygen therapy; 4) Oxygen by mask or nasal prong; 5a) Humidified high-flow oxygen; 5b) Non-invasive ventilation; 6) Intubation and mechanical Ventilation; 7) Ventilation + additional organ support-pressors, RRT, ECMO; 8) Death. The higher the score, the worse the outcome.
Measure: Time to an improvement of one category using an ordinal scale Time: Up through 28 days.Description: Modified WHO 8-point Ordinal Scale for Clinical Improvement. The scale is as follows: 0) No clinical or Virologic evidence of infection; 1) No limitation of activity; 2) Limitation of activity and/or home oxygen; 3) Hospitalized, no oxygen therapy; 4) Oxygen by mask or nasal prong; 5a) Humidified high-flow oxygen; 5b) Non-invasive ventilation; 6) Intubation and mechanical Ventilation; 7) Ventilation + additional organ support-pressors, RRT, ECMO; 8) Death. The higher the score, the worse the outcome.
Measure: Time to an improvement of two categories using an ordinal scale Time: Up through 28 days.Description: Modified WHO 8-point Ordinal Scale for Clinical Improvement. The scale is as follows: 0) No clinical or Virologic evidence of infection; 1) No limitation of activity; 2) Limitation of activity and/or home oxygen; 3) Hospitalized, no oxygen therapy; 4) Oxygen by mask or nasal prong; 5a) Humidified high-flow oxygen; 5b) Non-invasive ventilation; 6) Intubation and mechanical Ventilation; 7) Ventilation + additional organ support-pressors, RRT, ECMO; 8) Death. The higher the score, the worse the outcome.
Measure: Participant's clinical status by ordinal scale Time: Up through 28 days.Description: Modified WHO 8-point Ordinal Scale for Clinical Improvement. The scale is as follows: 0) No clinical or Virologic evidence of infection; 1) No limitation of activity; 2) Limitation of activity and/or home oxygen; 3) Hospitalized, no oxygen therapy; 4) Oxygen by mask or nasal prong; 5a) Humidified high-flow oxygen; 5b) Non-invasive ventilation; 6) Intubation and mechanical Ventilation; 7) Ventilation + additional organ support-pressors, RRT, ECMO; 8) Death. The higher the score, the worse the outcome.
Measure: Mean change in the ordinal scale Time: Days 2, 4, 7, 11, 14, 21, and 28.Description: The NEWS2 score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters. The NEW Score-2 is being used as an efficacy measure.
Measure: Time to discharge or to a National Early Warning Score (NEWS)-2 of = 2 and maintained for 24 hours, whichever occurs first Time: Up through 28 days.Description: The NEWS2 score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters. The NEW Score-2 is being used as an efficacy measure.
Measure: Change in NEWS-2 Score from Day 1 (baseline) to Days 2, 4, 7, 11, 15, and 29 Time: From Day 1 (baseline) to Days 2, 4, 7, 11, 15, and 29Description: Measured in days.
Measure: Duration of hospitalization Time: Day 1 through Day 28Description: Measured in days.
Measure: Number of hospitalizations related to COVID-19 Time: Day 1 through Day 28Description: An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Measure: Cumulative incidence of Serious Adverse Events (SAEs) Time: Day 1 through Day 29Description: Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.
Measure: Cumulative incidence of Grade 3 and 4 clinical and/or laboratory adverse events (AEs) Time: Day 1 through Day 29Description: Incidence of occurrence.
Measure: Incidence of discontinuation or temporary suspension of study product administrations (for any reason) Time: Day 1 through Day 29Description: g/dL
Measure: Change from baseline in hemoglobin Time: Day 1 to Days 2, 4, and 7 (while hospitalized); and Days 15 and 29 (if attends in-person visit or still hospitalized).Description: K/mcL
Measure: Change from baseline in platelets Time: Day 1 to Days 2, 4, and 7 (while hospitalized); and Days 15 and 29 (if attends in-person visit or still hospitalized).Description: mm/L
Measure: Change from baseline in creatinine Time: Day 1 to Days 2, 4, and 7 (while hospitalized); and Days 15 and 29 (if attends in-person visit or still hospitalized).Description: mg/dL
Measure: Change from baseline in glucose Time: Day 1 to Days 2, 4, and 7 (while hospitalized); and Days 15 and 29 (if attends in-person visit or still hospitalized).Description: mg/dL
Measure: Change from baseline in total bilirubin Time: Day 1 to Days 2, 4, and 7 (while hospitalized); and Days 15 and 29 (if attends in-person visit or still hospitalized).Description: U/L
Measure: Change from baseline in alanine transaminase (ALT) Time: Day 1 to Days 2, 4, and 7 (while hospitalized); and Days 15 and 29 (if attends in-person visit or still hospitalized).Description: U/L
Measure: Change from baseline in aspartate transaminase (AST) Time: Day 1 to Days 2, 4, and 7 (while hospitalized); and Days 15 and 29 (if attends in-person visit or still hospitalized).Description: PT reported as international normalized ratio (INR).
Measure: Change from baseline in prothrombin time (PT) Time: Day 1 to Days 2, 4, and 7 (while hospitalized); and Days 15 and 29 (if attends in-person visit or still hospitalized).Plasma, the supernatant part of blood, contains a variety of different proteins, including immunoglobulins. These proteins, also called antibodies, are directed to previous foreign infecting organisms, such as virus, bacteria or parasites. Patients recovering from SARS-Cov-2 infection may develop protective antibodies which can prevent reinfection with the same agent or similar organisms with shared molecular structures. Those antibodies may be transferred to other patients through collection of such convalescent plasma from recovered donors and its transfusion to ill patients. In this research, the primary hypothesis is that those antibodies can exert passive immunization and help ameliorate symptoms from COVID-19 (Coronavirus Disease 2019), resulting in higher clinical improvement rates at day 28, especially when administered early in the infection course.
Description: Improvement of 2 points from randomization in a 6-point ordinal severity scale (6 points, death; 5 points, hospitalization plus extracorporeal membrane oxygenation (ECMO) or invasive mechanical ventilation; 4 points, hospitalization plus noninvasive ventilation or high-flow supplemental oxygen; 3 points, hospitalization plus supplemental oxygen (not high-flow or noninvasive ventilation); 2 points, hospitalization with no supplemental oxygen; 1 point, hospital discharge)
Measure: Clinical improvement Time: 28 daysDescription: Proportions of individuals classified in each 6-point ordinal scale strata
Measure: 6-point ordinal scale proportion at 14 days Time: 14 days from randomizationDescription: Proportions of individuals classified in each 6-point ordinal scale strata
Measure: 6-point ordinal scale proportion at 28 days Time: 28 days from randomizationDescription: Death from any cause after randomization
Measure: Overall mortality Time: 14 daysDescription: Death from any cause after randomization
Measure: Overall mortality Time: 28 daysDescription: Days free of respiratory support during follow up
Measure: Days alive and free of respiratory support (DAFOR28) Time: 28 daysDescription: Duration of invasive ventilatory support (for those who received mechanical ventilation)
Measure: Mechanical ventilation Time: 28 daysDescription: PaO2/FiO2 ratio at 7 days of follow up
Measure: PaO2/FiO2 ratio Time: At the 7th day of randomizationDescription: Time from randomization to hospital discharge (for 28-day survivors)
Measure: Hospital stay Time: 28 daysDescription: LDH (U/L)
Measure: Lactate Dehydrogenase Time: Randomization day, Day 3, Day 7 and Day 14Description: Troponin I (pg/mL)
Measure: Troponin I Time: Randomization day, Day 3, Day 7 and Day 14Description: CRP (mg/L)
Measure: C Reactive Protein Time: Randomization day, Day 3, Day 7 and Day 14Description: D-Dimers (mcg/mL)
Measure: D-Dimers Time: Randomization day, Day 3, Day 7 and Day 14Description: Fibrinogen (mg/dL)
Measure: Fibrinogen Time: Randomization day, Day 3, Day 7 and Day 14Description: PT (seconds)
Measure: Prothrombin Time (PT) Time: Randomization day, Day 3, Day 7 and Day 14Description: APTT (seconds)
Measure: Activated Partial Thromboplastin Time (APTT) Time: Randomization day, Day 3, Day 7 and Day 14Description: TNF-Alfa (pg/mL)
Measure: Tumor Necrosis Factor Alfa (TNF-Alfa) Time: Randomization day, Day 3, Day 7 and Day 14Description: IL-6 (pg/mL)
Measure: Interleukin-6 (IL-6) Time: Randomization day, Day 3, Day 7 and Day 14Description: Nasal and Oropharyngeal Swab RT-PCR
Measure: RT-PCR Time: At the 7th day of randomization (or at hospital discharge if earlier than 7 days)Description: SOFA score at 7 days of randomization (ranges from 0 to 24, prognosis worsens with higher score values)
Measure: Sequential Organ Failure Assessment (SOFA) score Time: At the 7th day of randomizationDescription: Change in NEWS 2 from randomization at 7 days and 14 days (ranges from 0 to 20, prognosis worsens with higher score values)
Measure: National Early Warning Score 2 (NEWS) 2 Time: 7 and 14 days of randomizationDescription: CTCAE grade 3-4 events during follow up
Measure: Safety and Adverse Events Time: 28 daysThe principal objective of the CONFIDENT trial is to assess the efficacy of two units (400-500 mL in total) of convalescent plasma, as compared to Standard of Care (SoC), to reduce day-28 mortality in patients with SARS-CoV-2 pneumonia who require mechanical ventilation.
Description: dead or alive
Measure: Vital status Time: at day 28Description: dead or alive
Measure: day 90 mortality Time: at day 90Description: to assess the ventilator free days
Measure: number of ventilator-free days at day 28 Time: at day 28Description: to assess the number of renal replacement therapy free days
Measure: number of renal replacement therapy free days at day 28 Time: at day 28Description: to assess the number of vasopressors free-days
Measure: number of vasopressors free-days at day 28 Time: at day 28Description: to assess if ECMO was required
Measure: use of ECMO before day 28 Time: till day 28Description: to assess the value of SOFA score
Measure: value of the SOFA score at days 7, 14 and 28 Time: Day 1, 7, 14, 28Description: to assess the changes in SOFA scores (delta SOFA)
Measure: changes in SOFA scores (delta SOFA) over 7, 14 and 28 days Time: Day 7, 14 and 28 daysDescription: assessment of the SARS-CoV-2 viral load, expressed as cycle threshold, [2] in the tracheal aspirates (for intubated patients) or nasopharyngeal swabs (for extubated patients) at days 7, 14 and 28
Measure: assessment of the SARS-CoV-2 viral load Time: Days 7, 14 and 28Description: to assess the concentrations of C reactive protein (CRP)
Measure: blood C reactive protein (CRP) concentration Time: Days 7, 14 and 28Description: to assess the concentration of ferritin
Measure: ferritin concentration Time: Days 7, 14 and 28Description: to assess the count of lymphocyte
Measure: lymphocyte count Time: Days 7, 14 and 28Description: to assess the lenght of stay in the acute care
Measure: length of stay in the acute care hospital Time: through study completion, 1 yearDescription: to assess the location of the patient : acute care hospital, post acute care hospital, long-term residency, home
Measure: location of the patient Time: Day 90Description: to assess the Activity Day Living functional Min value: 0 = Low (patient very dependent) Max value: 6 = High (patient independent)
Measure: Katz Index of independence in Activity Day Living functional score Time: Day 90 and 365Description: to evaluate the anxiety-depression For each item 0-7 : Normal 8-10 : Bordeline abnormal (borderline case) 11-21 : Abnormal case
Measure: Hospital Anxiety and Depression Scale (HADS) Time: Day 90 and 365Description: The EQ-5D-5L is composed of - the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Each level corresponds to 1-digit number expressing the level selected for that dimension. The EQ VAS corresponds to a 20 cm vertical, visual analogue scale raging from 'the best health you can imagine' to 'the worst health you can imagine'.
Measure: Quality of life scale EQ-5D-5L Time: Day 90 and 365Description: to assess the transfusion related adverse events
Measure: Transfusion related adverse events Time: till 28 daysThe objective of this compassionate use study is to provide access and evaluate the outcome of Remdesivir and COVID-19 convalescent plasma use in patients with COVID-19. This protocol provides a coordinated approach for distribution and guidance for safe and effective administration of Remdesivir and convalescent plasma with antibodies against SARS CoV-2 for treatment of patients with COVID-19 infection who are most likely to benefit from this investigational treatment and monitor them for the following specific objectives and outcomes: SPECIFIC OBJECTIVES 1. Provide access to convalescent plasma for hospitalized patients with severe COVID-19 infection (compassionate use, expanded access program) 2. Monitor safety of the therapy with convalescent plasma containing antibodies against SAR CoV-2 and Remdesivir for hospitalized patients with severe COVID-19 infection 3. Evaluate outcomes in patients who received convalescent COVID-19 plasma therapy alone, Remdesivir alone, and both agents. Study Design: This study will be a prospective, observational clinical study with an intention-to-treat, cross-over design. Comparison groups will be patients who received convalescent plasma vs. those who received Remdesivir. In addition, cross-over to convalescent plasma arm will be allowed for patients who continued to get worse even after receiving Remdesivir for more than 48 hours.
Description: percentage of donors who donated plasma versus those who were eligible for donation percentage of patient who received plasma vs. requests received
Measure: Availability of convalescent plasma Time: 12 WeeksDescription: - amount of plasma administered per patient
Measure: Amount of Plasma Time: 12 WeeksDescription: - type of patients receiving plasma therapy : Age in Years, Sex: M/F,
Measure: Demographics of recipients Time: 12 WeeksDescription: - recipient comorbidities: Smoking, Diabetes, Heart disease, Chronic lung disease, chronic liver disease, cancer, organ transplant, HIV infection, TB. HIV, HBV, HCV, Syphillis
Measure: Co-morbidity of recipient Time: 12 WeeksDescription: donor health status: HIV, HBV, HCV, Syphillis Donor status: duration after recovery from COVID-19, plasma antibody titer against SARS CoV-2
Measure: Donor status Time: 12 WeeksDescription: any expected and unexpected adverse events during or after treatment (upto 7 days) any other complications related or unrelated to plasma transfusion and Remdesivir during hospital stay
Measure: Adverse events of convalescent COVID-19 plasma and Remdesivir Therapy Time: 12 WeeksDescription: - number of days of hospital stay and ICU stay
Measure: Hospital and ICU length of stay Time: 12 WeeksDescription: - condition at discharge: complete recovery, partial recovery with complications, death
Measure: Disposition of patients including survival Time: 12 WeeksAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports