Covid 19 Research using Clinical Trials (Home Page)
Convalescent plasmaWiki
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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1037 | trimethoprim/sulfamethoxazole Wiki | 0.50 |
| drug46 | Anakinra Wiki | 0.19 |
Correlated MeSH Terms (12)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D006819 | Hyaline Membrane Disease NIH | 0.50 |
| D003139 | Common Cold NIH | 0.35 |
| D029424 | Pulmonary Disease, Chronic Obstructive NIH | 0.29 |
| D012141 | Respiratory Tract Infections NIH | 0.26 |
| D008173 | Lung Diseases, Obstructive NIH | 0.25 |
| D003141 | Communicable Diseases NIH | 0.12 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.11 |
| D018352 | Coronavirus Infections NIH | 0.08 |
| D007239 | Infection NIH | 0.08 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.08 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.07 |
| D014777 | Virus Diseases NIH | 0.05 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There are 4 clinical trials
Clinical Trials
1 Anti-MERS-COV Convalescent Plasma Therapy
Since the first report of the Middle East Respiratory Syndrome Corona virus (MERS- CoV) in September 2012, more than 800 cases have been reported to the World Health Organization (WHO) with substantial mortality.
NCT02190799 Respiratory Distress Syndrome ( Respiratory Distress Syndrome (& Respiratory Distress Syndrome (& [Hyaline Membrane Disease Respiratory Distress Syndrome (& [Hyaline Membrane Disease] Respiratory Distress Syndrome (& [Hyaline Membrane Disease]) Biological: Convalescent plasma MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Hyaline Membrane Disease
Primary Outcomes
Description: Hospital mortality will be death in the ICU during the same hospital admission
Measure: Hospital mortality Time: Death in the Hospital (ICU or ward) before or at 6 months after enrollmentSecondary Outcomes
Description: Death in the ICU during the same hospital admission.
Measure: ICU mortality Time: Death in the ICU at or after 90 days of enrollmentDescription: Number of calendar days between admission and final discharge from ICU.
Measure: ICU Length of Stay Time: Number of days in ICU with an average expected duration of 10 days.Description: Number of calendar days between start and final liberation from mechanical ventilation.
Measure: Duration of Mechanical Ventilation Time: Number of days of mechanical ventilation with an expected average duration of 8 daysDescription: viral clearance from all sampled sites by day 3 after administration of CP
Measure: Viral load in tracheal aspirate Time: Serial levels in the first 28 days of enrollmentDescription: Epidermal Growth Factor (EGF), Eotaxin, Granulocyte colony-stimulating factor (G-CSF), Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), Interferon(IFN)-γ, IFN-a2, Interleukin (IL)-10, IL-12(p40), IL-12(p70), IL-13, IL-15, IL-17, IL-1ra, IL-1a, IL-1β, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, Interferon gamma-induced protein (IP)-10, Monocyte Chemotactic Protein (MCP)-1, Macrophage Inflammatory Protein (MIP)-1a, MIP-1β, Tumor Necrosis Factor-α (TNF-a), TNF-β, Vascular Endothelial Growth Factor (VEGF)
Measure: Inflammatory markers, Time: Serial levels in the first 28 days of enrollmentDescription: anti-MERS-CoV antibody level before and after administration of CP.
Measure: Anti-MERS-CoV antibodies Time: Serial levels in the first 28 days of enrollmentOther Outcomes
Description: X ray changes at day 0, 1, 3, 7, 14, 21 and 28
Measure: Chest X ray Time: Serial changes in the X ray till day 282 Convalescent Plasma Therapy From Recovered Covid-19 Patients as Therapy for Hospitalized Patients With Covid-19
Passive immunization with immunoglobulins is occasionally used as therapy for the treatment of viral infectious diseases. Immunoglobulins are used for the treatment of CMV disease, and is effective as prophylaxis when given soon after exposure to varicella zoster virus, rabies, and hepatitis B virus. Neutralizing antibodies against MERS, SARS-CoV-1 and SARS-CoV-2 have been shown to be present in patients previously infected with MERS, SARS-CoV-1 and SARS-CoV-2 respectively. During the 2003 SARS outbreak in Hong-Kong,a non-randomized study in hospitalized SARS patients showed that treatment with convalescent plasma (convP) from SARS-recovered donors significantly increased the day 22 discharge rate and decreased mortality. A study in non-human primates showed that rhesus macaques could not be re-infected with SARS-CoV-2 after primary infection. With no proven effective therapy against COVID-19, this protocol will evaluate the therapeutic potential of therapy with convalescent plasma from COVID-19 recovered donors. Primary objectives • Decrease overall mortality in patients within COVID disease Study design: This trial is a randomized comparative trial. Patients will be randomized between the infusion of 300mL of convP with standard of care. Patient population: Patients with PCR confirmed COVID disease, age >18 years Donors will be included with a known history of COVID who have been asymptomatic for at least 14 days. Intervention: 300mL of convP Duration of treatment: ConvP will be given as a one-time infusion Duration of follow up: Until discharge or death before day 60, whichever comes first Target number of patients: 426 Target number of donors: 100
NCT04342182 COVID-19 Biological: Convalescent plasma
Primary Outcomes
Description: the mortality in the 300ml convP group will be compared with the control arm
Measure: Overall mortality until discharge from the hospital or a maximum of 60 days after admission whichever comes first Time: until hospital discharge or a maximum of 60 days whichever comes firstSecondary Outcomes
Description: the hospital days in the 300ml convP group will be compared with the control arm
Measure: Impact of 300ml convP therapy on hospital days Time: until hospital discharge or a maximum of 60 days whichever comes firstDescription: A patient will be considered weaned from oxygen therapy when the patient did not receive oxygen for at least 24 hours.
Measure: Impact of 300ml convP on weaning from oxygen therapy Time: until hospital discharge or a maximum of 60 days whichever comes firstDescription: the overall mortality in hospital days in patients admitted tot the ICU within 24 hours after admission in the 300ml convP group will be compared with the patients admitted tot the ICU within 24 hours after admission in the control arm
Measure: Impact of 300ml convP on overall mortality in patients admitted to the ICU within 24 hours after admission Time: until hospital discharge or a maximum of 60 days whichever comes firstDescription: The mortality in patients with a duration of symptoms less than the median duration of symptoms in the study population will be compared with the mortality in patients with a duration of symptoms more than the median duration of symptoms in the study population
Measure: Difference in the effect of convP on mortality in patients with a duration of symptoms less or more the median duration of symptoms in the study population Time: hospital discharge or a maximum of 60 days whichever comes firstDescription: the ICU days in hospital days in patients admitted to the ICU within 24 hours after admission in the 300ml convP group will be compared with the patients admitted tot the ICU within 24 hours after admission in the control arm
Measure: Impact of 300ml convP therapy on ICU days in patients admitted to the ICU within 24 hours after admission Time: Until hospital discharge, estimated average 4 weeksDescription: airway samples will be taken on day 1 - 3 - 5 - 7 - 10 - 14 - and at discharge
Measure: Impact of plasma therapy on the decrease in SARS-CoV2 shedding from airways Time: until hospital discharge, estimated average 2 weeksDescription: Blood wil be drawn at day 1, day 7 and day 14
Measure: Impact of CTL and NK cell immunity on the likelihood of being protected from immune serum transfer Time: until hospital discharge, extimated average 2 weeksDescription: Evaluation of Severe Adverse Events and transfusion related adverse events
Measure: Safety of convP therapy Time: until hospital discharge or a maximum of 60 days whichever comes first3 A Randomized Open-Label Trial of CONvalenscent Plasma for Hospitalized Adults With Acute COVID-19 Respiratory Illness (CONCOR-1)
There is currently no treatment available for COVID-19, the acute respiratory illness caused by the novel SAR-CoV-2. Convalescent plasma from patients who have recovered from COVID-19 that contains antibodies to the virus is a potential therapy. On March 25th, 2020, the FDA approved the use of convalescent plasma under the emergency investigational new drug (eIND) category. Randomized trials are needed to determine the efficacy and safety of COVID-19 convalescent plasma for acute COVID-19 infection. The objective of the CONCOR-1 trial is to determine the efficacy of transfusion of COVID-19 convalescent plasma to adult patients admitted to hospital with COVID-19 infection at decreasing the frequency of in-hospital mortality in patients hospitalized for COVID-19. It is hypothesized that treating hospitalized COVID-19 patients with convalescent plasma early in their clinical course will reduce the risk of death, and that other outcomes will be improved including risk of intubation, and length of ICU and hospital stay. This pan-Canadian clinical trial has the potential to improve patient outcomes and reduce the burden on health care resources including reducing the need for ICU beds and ventilators.
NCT04348656 COVID-19 Other: Convalescent plasma
Primary Outcomes
Description: Endpoint of the need for intubation or patient death in hospital
Measure: Intubation or death in hospital Time: Day 30Secondary Outcomes
Description: Endpoint of the need for intubation before 30 days
Measure: Need for Intubation Time: Day 30Description: Time in hours to intubation from randomization
Measure: Time to intubation Time: Day 30Description: Endpoint of the number of days off ventilator at 30 days
Measure: Ventilator-free days Time: Day 30Description: In-hospital death censored at 90 days
Measure: In-hospital death Time: 90 daysDescription: Time to in-hospital death at 90 days
Measure: Time to in-hospital death Time: Day 90Description: Death at 30 days
Measure: Death at 30 days Time: 30 daysDescription: Date of intensive care unit admission (first date and total number of days)
Measure: Length of stay in intensive care unit (ICU) Time: Day 30Description: Date of hospital admission (first date and total number of days)
Measure: Length of stay in hospital Time: Day 30Description: First date on ECMO and total number of days
Measure: Need for extracorpeal membrane oxygenation (ECMO) Time: Day 30Description: Need for renal replacement therapy
Measure: Need for renal replacement therapy Time: Day 30Description: New myocarditis
Measure: Development of myocarditis Time: Day 30Description: Transfusion-associated adverse events, Grade 3 and 4 serious adverse events, and cumulative incidence of Grade 3 and 4 adverse events and serious adverse events (using medDRA)
Measure: Adverse events and serious adverse events Time: Day 30Description: CCP transfusion-associated adverse events (AE)
Measure: CCP transfusion-associated adverse events (AE) Time: 30 days4 COPLA Study: Treatment of Severe Forms of COronavirus Infection With Convalescent PLAsma
COVID-19 disease has become a very serious global health problem. Treatments for severe forms are urgently needed to lower mortality. Any procedure that improves these forms should be considered, especially those devoid of serious side effects.There is not enough published information on the use of allogeneic convalescent plasma (ACP) in the treatment of severe forms of COVID-19. The use of ACP can be combined with other treatments and has very few adverse effects. It takes 10-14 days for SARS-CoV2-infected patients to produce virus-neutralizing antibodies: within that time they can develop serious complications and die. Injecting PAC into patients with severe forms of COVID-19 shortens the period of risk while the patient produces the antibodies.
NCT04357106 COVID-19 Biological: Convalescent plasma MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome
Primary Outcomes
Description: PaO2/FiO2 relation
Measure: Lung injury Time: 7 daysDescription: Patients survival after therapy
Measure: Overall survival Time: 15-30 daysSecondary Outcomes
Description: Determine the incidence of side effects from plasma administration
Measure: Adverse reactions to plasma Time: 7 days