CovidResearchTrials by Shray Alag

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COVID-19 convalescent plasmaWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (9)

Name (Synonyms) Correlation
drug1857 Placebo to match filgotinib Wiki 0.50
drug182 Anti-COVID-19 human immunoglobulin Wiki 0.50
drug2798 data record Wiki 0.50
drug940 Filgotinib Wiki 0.50
drug2297 Standard (specific) therapy for COVID-19 Wiki 0.50
drug2125 SARILUMAB Wiki 0.50
drug1856 Placebo to match adalimumab Wiki 0.50
drug2442 Taking blood samples for analyzing progesterone levels Wiki 0.50
drug123 Adalimumab Wiki 0.50

Correlated MeSH Terms (4)

Name (Synonyms) Correlation
D015535 Arthritis, Psoriatic NIH 0.25
D001168 Arthritis NIH 0.14
D018352 Coronavirus Infections NIH 0.06
D045169 Severe Acute Respiratory Syndrome NIH 0.05

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0001369 Arthritis HPO 0.14

There are 4 clinical trials

Clinical Trials

1 Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19

This expanded access program will provide 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.

NCT04338360 COVID19 Biological: COVID-19 convalescent plasma

2 Efficacy and Safety of Early Anti-SARS-COV-2 Convalescent Plasma in Patients Admitted for COVID-19 Infection: a Randomized Phase II Trial

Currently there is no standard treatment for SARS-CoV-2 infection. Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including SARS-CoV-1 , MERS-CoV and Hantavirus infection. This study is an open-label randomized trial in which patients with high risk of COVID19-associated respiratory failure will be randomized to early treatment with convalescent plasma (≤ 7 days from symptoms start) or at early signs of respiratory failure or prolonged hospitalization. COVID-19 convalescent plasma will be collected from individuals according to the institutional protocol.

NCT04375098 Severe Acute Respiratory Syndrome Coronavirus 2 Biological: COVID-19 convalescent plasma
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Percentage Mechanical Ventilation, hospitalization longer than 14 days or death during hospitalization

Time: 1 year follow up

Secondary Outcomes

Description: Days

Measure: Median duration of fever

Time: 1 year

Description: Days

Measure: Median duration of mechanical ventilation

Time: 1 year follow up

Description: Days

Measure: Median length of ICU stay

Time: 1 year follow up

Description: Days

Measure: Median length of admission

Time: 1 year follow up

Measure: Hospital mortality rate (percentage)

Time: 1 year follow up

Measure: 30-day mortality (percentage)

Time: 1 year follow up

Measure: Readmission rate (percentage)

Time: 1 year follow up

Description: days

Measure: Median length of viral clearance

Time: 1 year follow up

3 A Randomized, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the Use of Convalescent Plasma (PC) and Human Intravenous Anti COVID-19 Immunoglobulin (IV Anti COVID-19 IgG) in Patients Hospitalized for COVID-19.

A randomized, open-label, multicenter, three-arm clinical trial to study the efficacy and safety of passive immunotherapy (convalescent plasma and anti-COVID-19 human immunoglobulin) compared to the standard treatment in Colombia.

NCT04395170 Coronavirus Disease 2019 (COVID-19) Biological: COVID-19 convalescent plasma Biological: Anti-COVID-19 human immunoglobulin Drug: Standard (specific) therapy for COVID-19
MeSH:Coronavirus Infections

Primary Outcomes

Description: Admission to the intensive care unit with the requirement of mechanical ventilation (invasive or non-invasive) due to Acute Respiratory Distress Syndrome by COVID-19.

Measure: Admission to ICU and/or mechanical ventilation

Time: One year

Secondary Outcomes

Description: Time in the hospital from admission to discharge or death.

Measure: Length of hospital stay

Time: One year

Description: Neutralizing antibody (IgG) titers against COVID-19

Measure: Neutralizing antibody (IgG) titers against COVID-19

Time: One year

Description: Non-serious adverse events (NSAEs) and serious adverse events (SAEs)

Measure: Safety - Adverse events

Time: One year

Description: Overall mortality

Measure: Death

Time: One year

4 ANTIBODY-LEVEL BASED ANALYSIS OF COVID-19 CONVALESCENT SERUM (ABACCuS)

The goal of this study is to evaluate the safety and effectiveness of COVID-19 convalescent plasma for the treatment of COVID-19. Plasma is the liquid part of blood that is left when all the blood cells have been removed. Convalescent means it is taken from people who were infected with COVID-19 and recovered. The use of this blood product to treat COVID-19 is investigational, which means the U.S. Food and Drug Administration has not yet approved it to be sold commercially. This is a human blood product collected by licensed blood banks. Donors of COVID-19 convalescent plasma must meet all standard blood donor criteria and must also meet all criteria set by the FDA for being a donor of COVID-19 convalescent plasma. A total of 500 patients will take part in the study at 8 hospitals within Beaumont. Similar studies are being done at other centers, but they are not directly related to this study. Participants will be assigned to a study group depending on how sick they are. - Group A: Those who require more than 6 liters (L) of supplemental oxygen but are not on a ventilator - Group B: Those who require a ventilator to preserve their life. Both groups will receive one unit (approximately 200ml or just under 1 cup) of COVID convalescent plasma. The transfusion will be given over about 30 minutes via an IV. Blood samples will be taken prior to and one hour after the transfusion to measure participant antibodies against SARS-CoV-2 and a nasopharyngeal swab (deep in the nostril) will be taken to test for presence of the SARS-CoV-2 virus. One hour after the transfusion a blood sample will be taken to measure antibody levels to determine if the plasma caused the antibody level to rise. Similarly, blood samples will be taken to measure antibodies against SARS-CoV-2 and a nasopharyngeal swab will be taken to test for presence of the SARS-CoV-2 virus 1, 3 and every 7 days after the transfusion while the participant is in the hospital The participant's final health status will be determined on day 28. Hospital records will be monitored for 90 days after discharge to determine if the participant is readmitted to the hospital.

NCT04432272 COVID-19 Severe Acute Respiratory Syndrome (SARS) Coronavirus Infections Biological: COVID-19 convalescent plasma
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Count of group A participants (non-intubated participants requiring >6 L supplemental oxygen to maintain oxygen saturation >92% at time of study entry and who are admitted <14 days) who remain un-intubated

Measure: Avoidance of intubation at 28 days (group A)

Time: 28 days

Description: Count of group B participants (participants who are intubated at study entry) who die

Measure: Mortality (group B)

Time: 28 days

Secondary Outcomes

Description: Count of participants who experienced cardio-circulatory arrest

Measure: Cardio-circulatory arrest

Time: 28 days

Description: Patient Outcome as assessed on a 7-point ordinal scale, where 1= Not hospitalized, no limitations on activities, 2 =Not hospitalized, limitation on activities, 3= Hospitalized, not requiring supplemental oxygen, 4 =Hospitalized, requiring supplemental oxygen , 5 = Hospitalized, on non-invasive ventilation or high flow oxygen devices, 6 = Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), 7=Deceased. A lower number indicates a better outcome

Measure: Patient Outcome at 28 days

Time: 28 days

Description: Count of participants who develop or experience worsened renal failure as defined by RIFLE criteria, a 5-point scale where the categories are labeled: Risk-Injury-Failure-Loss-End stage renal disease, with Risk being the least severe and End stage renal disease being the most severe. The criteria for determination of stage are factors of serum creatinine and urine output. Numbers of participants worsening one or more RIFLE stages will be reported.

Measure: Renal failure

Time: 28 days

Description: Count of participants who develop or experience worsened liver failure as measured by elevation of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels to 5x the upper limit of normal or significant worsening of current liver failure with rise in transaminases of >25%

Measure: Liver failure

Time: 28 days

Description: Count of participants who develop cytokine storm as measured by elevated markers of inflammation (elevated D-dimer, hypofibrinogenemia, hyperferritinemia), evidence of acute respiratory distress syndrome (ARDS) measured by imaging findings and mechanical ventilator requirements, and/or continuous fever (≥ 38.1 ° Celsius unremitting)

Measure: Cytokine Storm

Time: 28 days

Description: Count of participants who require respiratory support in each of the following categories: nasal cannula, high flow nasal canula, non-rebreather, continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or intubation .

Measure: Respiratory support

Time: 28 days

Description: Count of participants who received pressor drugs, as ordered by treating physicians

Measure: Vasopressor medication support

Time: 28 days

Description: Length of ICU stay in days, for participants who entered ICU

Measure: Length of ICU length of stay

Time: 28 days

Description: Count of patients admitted to the ICU who die in ICU

Measure: Intensive Care Unit (ICU) mortality

Time: 28 days

Description: Length of hospital stay in days

Measure: Hospital length of stay

Time: 28 days

Description: Number of ventilator-free hospitalized days

Measure: Ventilator free days

Time: 28 days

Description: Length of intubation, measured in days

Measure: Intubation duration

Time: 28 days

Description: Count of participants readmitted to hospital following index procedure hospital discharge

Measure: Readmission

Time: 90 days

Description: Count of participants positive for serum anti-SARS-CoV-2 IgG as assayed by the EUROIMMUN Anti-SARS-CoV-2 assay, evaluated semi-quantitatively by calculation of a ratio of the extinction of the patient sample over the extinction of a calibrator. This ratio is interpreted as: ratio < 0.8 is negative, ratio ≥ 0.8 to <1.0 is considered borderline, and ratio ≥ 1.1 is positive.

Measure: Serum anti-SARS-CoV-2 IgG

Time: During hospitalization, a maximum of 28 days

Description: Count of participants with presence of SARS-CoV-2 RNA detected by reverse transcription polymerase chain reaction (RT-PCR) tested nasopharyngeal swabs.

Measure: SARS-CoV-2 RNA

Time: During hospitalization, a maximum of 28 days

Description: Count of group A participants (non-intubated participants requiring >6 L supplemental oxygen to maintain oxygen saturation >92% at time of study entry and admitted <14 days) who die

Measure: Mortality (group A)

Time: 28 days

Description: Number of days from transfusion date until end of ventilator support for surviving group B participants (participants who are intubated at study entry)

Measure: Time from Transfusion to end of ventilator support (group B)

Time: During hospitalization, a maximum of 28 days

No related HPO nodes (Using clinical trials)