Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fundació d'investigació Sanitària de les Illes Balears | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
The coronavirus disease 2019 (COVID-19) was classified as a pandemic by the World Health Organization (WHO) in March 2020. The SARS-COV-2 virus is easily transmissible and there is currently no approved treatment with effective results. Although the main epidemiological parameters are currently being studied, apparently the speed of contagion, the incidence and the mortality rate in severe cases appear to be high. Therefore, there is an urgent need to find a viable therapeutic option. The present trial is a pilot study with an objective to determine the efficacy of standard treatment reinforced with two repeated doses in two consecutive days of plasma from former convalescent people of the COVID-19 disease already discharged and / or with results in negative COVID-19 screenings, transfused to hospitalized COVID-19 patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Other | Standard treatment for COVID-19 (according to clinical guidelines for COVID-19). |
|
| Intervention group | Experimental | Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Convalescent Plasma with antibody against SARS-CoV-2. | Other | Convalescent plasma plus standard treatment for COVID-19. The convalescent plasma is from patients recovered from COVID-19 and negative viremia in the test detection COVID-19. The infusions will be given on days 1 and 2, of the study, after the positive result for COVID-19 of the recipient patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II | The scale provides a measure of COVID-19 severity based on the patient's physical situation, whose design was based on a blueprint of the WHO in treating COVID-19.
| Day 7 |
| Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II | The scale provides a measure of COVID-19 severity based on the patient's physical situation, whose design was based on a blueprint of the WHO in treating COVID-19.
| Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-SARS-CoV-2 S IgG Serum Titer | The levels of Anti-SARS-CoV-2 S IgG serum | At inclusion, Day 21 |
| Time of Hospitalization | time that the patients have passed in the hospital. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Son Llatzer | Palma de Mallorca | Islas de Balears | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35683427 | Result | Bargay-Lleonart J, Sarubbo F, Arrizabalaga M, Guerra JM, Borras J, El Haji K, Flexas M, Perales J, Fernandez-Baca V, Gallegos C, Cruz MR, Velasco S, Lopez V, Cruz A, Bautista-Gili A, Jimenez-Marco T, Girona-Llobera E, Vilaplana L, Calonge L, Tena J, Galan MP, Payeras A. Reinforcement of the Standard Therapy with Two Infusions of Convalescent Plasma for Patients with COVID-19: A Randomized Clinical Trial. J Clin Med. 2022 May 27;11(11):3039. doi: 10.3390/jcm11113039. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Standard treatment for COVID-19 (according to clinical guidelines for COVID-19). Standard treatment for COVID-19: The patients will receive the standard treatment for COVID-19, according to guidelines for COVID-19 (retrovirals drugs, interferon-α / β, anti-IL-6 monoclonal antibody, oxygen therapy, etc..) |
| FG001 | Intervention Group | Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines). Convalescent Plasma with antibody against SARS-CoV-2.: Convalescent plasma plus standard treatment for COVID-19. The convalescent plasma is from patients recovered from COVID-19 and negative viremia in the test detection COVID-19. The infusions will be given on days 1 and 2, of the study, after the positive result for COVID-19 of the recipient patient. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Standard treatment for COVID-19 (according to clinical guidelines for COVID-19). |
| BG001 | Intervention Group | Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II | The scale provides a measure of COVID-19 severity based on the patient's physical situation, whose design was based on a blueprint of the WHO in treating COVID-19.
| Posted | Count of Participants | Participants | Day 7 |
|
21 days
[Not Specified]
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Standard treatment for COVID-19 (according to clinical guidelines for COVID-19). |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin rash (Grade 1) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joan Bargay Lleonart | Son Llàtzer University Hospital | 34871202000 | khaoulahelhaji@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 3, 2020 | Nov 9, 2023 | Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard treatment for COVID-19 | Other | The patients will receive the standard treatment for COVID-19, according to guidelines for COVID-19 (retrovirals drugs, interferon-α / β, anti-Interleukin-6 monoclonal antibody, oxygen therapy, etc..) |
|
| Day 21 |
| Time to Negativization of RT-PCR | total time elapsed until negative RT-PCR test | Day 21 |
| Diastolic Blood Pressure | the pressure of blood in the artery when the heart relaxes between beats. | At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21 |
| Systolic Blood Pressure | The pressure of blood in the artery when the heart contracts. It is the high number in a blood pressure measurement. | At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21 |
| Temperature | At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21 |
| Cardiac Frequency | The number of heart contractions or beats per unit of time. The normal values in adults at rest range between 60 and 100 beats per minit. | At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21 |
| Respiratory Frequency | Number of breaths the patient takes per minute. | At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21 |
| Oxygen Saturation | blood oxygen percentage. A healthy percentage of oxygen in the blood is between 95% and 100%. | At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21 |
| Hemoglobin | hemoglobin levels in the blood | At inclusion, Day 3, Day 7, Day 14, Day 21 |
| Leucocytes | Leucocyte count a patient's blood. | At inclusion, Day 3, Day 7, Day 14, Day 21 |
| Neutrophils | Neutrophils count a patient's blood. | At inclusion, Day 3, Day 7, Day 14, Day 21 |
| Absolute Lymphocytes | lymphocyte count a patient's blood. | At inclusion, Day 3, Day 7, Day 14, Day 21 |
| Activated Partial Thromboplastin Time | measurement of the number of seconds it takes for a clot to form in a patient's blood. | At inclusion, Day 3, Day 7, Day 14, Day 21 |
| Fibrinogen Level | measurement of the level of fibrinogen in the blood (mg / dl), as a measure of assessing the severity of the disease. | At inclusion, Day 3, Day 7, Day 14, Day 21 |
| Fragment D-dimer Assessment | Determination of the existence of the D-dimer fragment in blood as a measure of assessing the severity of the disease. | At inclusion, Day 3, Day 7, Day 14 |
| Glomerular Filtration Rate Assessment | estimation of how much blood passes per minute through the glomerular filters of the kidneys (ml/min). | At inclusion, Day 3, Day 7, Day 14, Day 21 |
| Troponin I Assessment | measurement of the levels of troponin I proteins in the blood (ng/mL), as a measure of assessing the severity of the disease. | At inclusion, Day 3, Day 7, Day 14, Day 21 |
| Procalcitonin Assessment | measurement of the levels of procalcitonin in the blood (ng/L), as a measure of assessing the severity of the disease. | At inclusion, Day 3, Day 7, Day 14, Day 21 |
| C-reactive Protein Assessment | measurement of the level of c-reactive protein in the blood (mg/dl), as a measure of a change in inflammation | At inclusion, Day 3, Day 7, Day 14, Day 21 |
| Lactate Dehydrogenase (LDH) Assessment | measurement of the level of lactate dehydrogenase in the blood (U/L), as a measure of assessing the severity of the disease. | At inclusion, Day 3, Day 7, Day 14, Day 21 |
| Interleukin-6 Assessment | measurement of serum levels Interleukin-6 in pg/mL, as a measure of assessing the severity of the disease. | At inclusion, Day 3, Day 7, Day 14, Day 21 |
| Ferritin Blood Assessment | measurement of the amount of ferritin (blood protein) in ng/ml in the blood, as a measure of assessing the severity of the disease. | At inclusion, Day 3, Day 7, Day 14, Day 21 |
| Percentage of Patients Requiring Admission to Intensive Care Units. | Percentage of patients requiring admission to intensive care units. | Day 21 |
| Mortality Rate at 15 Days | number of dead participants through day 15 | Day 15 |
| Mortality Rate at 30 Days | number of dead participants through day 30 | Day 30 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Concomitant illnesses | Type of concomitant illnesses are cardiac diseases, respiratory diseases, digestive diseases, neurological diseases, psychiatric diseases, nephrological diseases, ophthalmological diseases, dermatological diseases, endocrinological diseases, rheumatic/osteoarticular diseases and immunity diseases | Count of Participants | Participants |
|
| Concomitant medication | Count of Participants | Participants |
|
| Smoke | Count of Participants | Participants |
|
| Drug abuse habits | Addictive use of psychoactive substances such as amphetamines, cocaine, marijuana, ecstasy, etc... | Count of Participants | Participants |
|
| Standard treatment | Number | participants |
|
| OG001 | Intervention Group | Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines). |
|
|
| Primary | Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II | The scale provides a measure of COVID-19 severity based on the patient's physical situation, whose design was based on a blueprint of the WHO in treating COVID-19.
| Posted | Count of Participants | Participants | Day 14 |
|
|
|
| Secondary | Anti-SARS-CoV-2 S IgG Serum Titer | The levels of Anti-SARS-CoV-2 S IgG serum | Posted | Mean | Standard Error | AU/ ml | At inclusion, Day 21 |
|
|
|
| Secondary | Time of Hospitalization | time that the patients have passed in the hospital. | Posted | Mean | Standard Error | days | Day 21 |
|
|
|
| Secondary | Time to Negativization of RT-PCR | total time elapsed until negative RT-PCR test | Posted | Mean | Standard Error | days | Day 21 |
|
|
|
| Secondary | Diastolic Blood Pressure | the pressure of blood in the artery when the heart relaxes between beats. | Posted | Mean | Standard Error | mmHg | At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21 |
|
|
|
| Secondary | Systolic Blood Pressure | The pressure of blood in the artery when the heart contracts. It is the high number in a blood pressure measurement. | Posted | Mean | Standard Error | mmHg | At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21 |
|
|
|
| Secondary | Temperature | Posted | Mean | Standard Error | degrees Celsius | At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21 |
|
|
|
| Secondary | Cardiac Frequency | The number of heart contractions or beats per unit of time. The normal values in adults at rest range between 60 and 100 beats per minit. | Posted | Mean | Standard Error | beats/minit | At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21 |
|
|
|
| Secondary | Respiratory Frequency | Number of breaths the patient takes per minute. | Posted | Mean | Standard Error | breath/minut | At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21 |
|
|
|
| Secondary | Oxygen Saturation | blood oxygen percentage. A healthy percentage of oxygen in the blood is between 95% and 100%. | Posted | Mean | Standard Error | percentage of blood oxygen | At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21 |
|
|
|
| Secondary | Hemoglobin | hemoglobin levels in the blood | Posted | Mean | Standard Error | g/dL | At inclusion, Day 3, Day 7, Day 14, Day 21 |
|
|
|
| Secondary | Leucocytes | Leucocyte count a patient's blood. | Posted | Mean | Standard Error | cells x10^9/L | At inclusion, Day 3, Day 7, Day 14, Day 21 |
|
|
|
| Secondary | Neutrophils | Neutrophils count a patient's blood. | Posted | Mean | Standard Error | cells x10^9/L | At inclusion, Day 3, Day 7, Day 14, Day 21 |
|
|
|
| Secondary | Absolute Lymphocytes | lymphocyte count a patient's blood. | Posted | Mean | Standard Error | cells x10^9/L | At inclusion, Day 3, Day 7, Day 14, Day 21 |
|
|
|
| Secondary | Activated Partial Thromboplastin Time | measurement of the number of seconds it takes for a clot to form in a patient's blood. | Posted | Mean | Standard Error | seconds | At inclusion, Day 3, Day 7, Day 14, Day 21 |
|
|
|
| Secondary | Fibrinogen Level | measurement of the level of fibrinogen in the blood (mg / dl), as a measure of assessing the severity of the disease. | Posted | Mean | Standard Error | mg/dL | At inclusion, Day 3, Day 7, Day 14, Day 21 |
|
|
|
| Secondary | Fragment D-dimer Assessment | Determination of the existence of the D-dimer fragment in blood as a measure of assessing the severity of the disease. | Posted | Mean | Standard Error | ng/mL | At inclusion, Day 3, Day 7, Day 14 |
|
|
|
| Secondary | Glomerular Filtration Rate Assessment | estimation of how much blood passes per minute through the glomerular filters of the kidneys (ml/min). | Posted | Mean | Standard Error | ml/min | At inclusion, Day 3, Day 7, Day 14, Day 21 |
|
|
|
| Secondary | Troponin I Assessment | measurement of the levels of troponin I proteins in the blood (ng/mL), as a measure of assessing the severity of the disease. | Posted | Mean | Standard Error | ng/mL | At inclusion, Day 3, Day 7, Day 14, Day 21 |
|
|
|
| Secondary | Procalcitonin Assessment | measurement of the levels of procalcitonin in the blood (ng/L), as a measure of assessing the severity of the disease. | Posted | Mean | Standard Error | ng/L | At inclusion, Day 3, Day 7, Day 14, Day 21 |
|
|
|
| Secondary | C-reactive Protein Assessment | measurement of the level of c-reactive protein in the blood (mg/dl), as a measure of a change in inflammation | Posted | Mean | Standard Error | mg/dL | At inclusion, Day 3, Day 7, Day 14, Day 21 |
|
|
|
| Secondary | Lactate Dehydrogenase (LDH) Assessment | measurement of the level of lactate dehydrogenase in the blood (U/L), as a measure of assessing the severity of the disease. | Posted | Mean | Standard Error | Unit/L | At inclusion, Day 3, Day 7, Day 14, Day 21 |
|
|
|
| Secondary | Interleukin-6 Assessment | measurement of serum levels Interleukin-6 in pg/mL, as a measure of assessing the severity of the disease. | Posted | Mean | Standard Error | pg/mL | At inclusion, Day 3, Day 7, Day 14, Day 21 |
|
|
|
| Secondary | Ferritin Blood Assessment | measurement of the amount of ferritin (blood protein) in ng/ml in the blood, as a measure of assessing the severity of the disease. | Posted | Mean | Standard Deviation | ng/mL | At inclusion, Day 3, Day 7, Day 14, Day 21 |
|
|
|
| Secondary | Percentage of Patients Requiring Admission to Intensive Care Units. | Percentage of patients requiring admission to intensive care units. | Posted | Number | percentage of participants | Day 21 |
|
|
|
| Secondary | Mortality Rate at 15 Days | number of dead participants through day 15 | Posted | Count of Participants | Participants | Day 15 |
|
|
|
| Secondary | Mortality Rate at 30 Days | number of dead participants through day 30 | Posted | Count of Participants | Participants | Day 30 |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Intervention Group | Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines). | 0 | 37 | 0 | 37 | 4 | 37 |
| Left ear hearing los | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Mild dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Left hypochondrium pain | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 6 |
|
| Grade 7 |
|
| Grade 8 |
|
| Day 3 |
|
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 3 |
|
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 3 |
|
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 3 |
|
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 3 |
|
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 3 |
|
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 7 |
|
| Day 14 |
|
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|