|drug263||Chloroquine Diphosphate Wiki||0.58|
|drug563||Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus Wiki||0.58|
|drug865||Placebo oral tablet Wiki||0.12|
|D018352||Coronavirus Infections NIH||0.06|
|D045169||Severe Acute Respiratory Syndrome NIH||0.03|
There are 3 clinical trials
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.
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 dysfunctionMeasure: Change in COVID-19 severity status Time: Up to 09 days
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?
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
Description: days of stay at ICU will be evaluatedMeasure: days at ICU Time: day 0 to day +30
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.
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 eventsMeasure: Adverse events that require study treatment interruption Time: During the 28 day of follow up
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 baselineMeasure: 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 studyMeasure: 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 dayMeasure: 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