Brief Summary
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.
Brief Title
CONTAIN COVID-19: Convalescent Plasma to Limit COVID-19 Complications in Hospitalized Patients
Detailed Description
A total of 300 eligible subjects will be randomized in a 1:1 ratio to receive either convalescent plasma (CP) from people who have recovered from COVID-19 containing antibodies to SARS-CoV-2 or a placebo control, Lactated Ringer's Solution (LR) or saline solution (SS). Hospitalized COVID-19 patients aged ≥18 years of age with respiratory symptoms within 3 to 7 days from the onset of illness OR within 3 days of hospitalization will be eligible to participate.
Categories
Completion Date
Completion Date Type
Actual
Conditions
COVID-19
Coronavirus
Coronavirus Infection
Eligibility Criteria
Inclusion Criteria
1. Patients ≥18 years of age
2. Hospitalized with laboratory confirmed COVID-19
3. One or more of the following respiratory signs or symptoms: cough, chest pain, shortness of breath, fever, oxygen saturation ≤ 94%, abnormal CXR/CT imaging)
4. Hospitalized for ≤ 72 hours OR within day 3 to 7 days from first signs of illness
5. On supplemental oxygen, non-invasive ventilation or high-flow oxygen
6. Patients may be on other randomized controlled trials of pharmaceuticals for COVID -19 and patients who meet eligibility criteria will not be excluded on this basis.
Exclusion Criteria
1. Receipt of pooled immunoglobulin in past 30 days
2. Contraindication to transfusion or history of prior reactions to transfusion blood products
3. Invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
4. Volume overload secondary to congestive heart failure or renal failure
5. Unlikely to survive past 72 hours from screening based on the assessment of the investigator
6. Unlikely to be able to assess and follow outcome due to poor functional status
1. Patients ≥18 years of age
2. Hospitalized with laboratory confirmed COVID-19
3. One or more of the following respiratory signs or symptoms: cough, chest pain, shortness of breath, fever, oxygen saturation ≤ 94%, abnormal CXR/CT imaging)
4. Hospitalized for ≤ 72 hours OR within day 3 to 7 days from first signs of illness
5. On supplemental oxygen, non-invasive ventilation or high-flow oxygen
6. Patients may be on other randomized controlled trials of pharmaceuticals for COVID -19 and patients who meet eligibility criteria will not be excluded on this basis.
Exclusion Criteria
1. Receipt of pooled immunoglobulin in past 30 days
2. Contraindication to transfusion or history of prior reactions to transfusion blood products
3. Invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
4. Volume overload secondary to congestive heart failure or renal failure
5. Unlikely to survive past 72 hours from screening based on the assessment of the investigator
6. Unlikely to be able to assess and follow outcome due to poor functional status
Inclusion Criteria
Inclusion Criteria
1. Patients ≥18 years of age
2. Hospitalized with laboratory confirmed COVID-19
3. One or more of the following respiratory signs or symptoms: cough, chest pain, shortness of breath, fever, oxygen saturation ≤ 94%, abnormal CXR/CT imaging)
4. Hospitalized for ≤ 72 hours OR within day 3 to 7 days from first signs of illness
5. On supplemental oxygen, non-invasive ventilation or high-flow oxygen
6. Patients may be on other randomized controlled trials of pharmaceuticals for COVID -19 and patients who meet eligibility criteria will not be excluded on this basis.
1. Patients ≥18 years of age
2. Hospitalized with laboratory confirmed COVID-19
3. One or more of the following respiratory signs or symptoms: cough, chest pain, shortness of breath, fever, oxygen saturation ≤ 94%, abnormal CXR/CT imaging)
4. Hospitalized for ≤ 72 hours OR within day 3 to 7 days from first signs of illness
5. On supplemental oxygen, non-invasive ventilation or high-flow oxygen
6. Patients may be on other randomized controlled trials of pharmaceuticals for COVID -19 and patients who meet eligibility criteria will not be excluded on this basis.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04364737
Org Class
Other
Org Full Name
NYU Langone Health
Org Study Id
20-00541
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
CONTAIN COVID-19: Convalescent Plasma to Limit Coronavirus Associated Complications: a Randomized Blinded Phase 2 Study Comparing the Efficacy and Safety of Anti-SARS-CoV2 Plasma to Placebo in COVID-19 Hospitalized Patients
Primary Outcomes
Outcome 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
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
Outcome Measure
Score on the WHO 11-point Ordinal Scale for Clinical Improvement at 14 Days
Outcome Time Frame
14 days post-randomization
Secondary Outcomes
Outcome 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
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
Outcome Time Frame
28 days post-randomization
Outcome Measure
Score on the WHO 11-point Ordinal Scale for Clinical Improvement at 28 Days
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Liise-anne Pirofski
Investigator Email
l.pirofski@einsteinmed.org
Investigator Phone
718-430-2940
Categories Mesh Debug
COVID-19 --- COVID-19
COVID-19 --- CORONAVIRUS INFECTIONS
COVID-19 --- PNEUMONIA, VIRAL
COVID-19 --- PNEUMONIA
Lung --- PNEUMONIA
COVID-19 --- RESPIRATORY TRACT INFECTIONS
Lung --- RESPIRATORY TRACT INFECTIONS
COVID-19 --- INFECTIONS
Infectious Disease --- INFECTIONS
COVID-19 --- VIRUS DISEASES
Hepatitis --- VIRUS DISEASES
Infectious Disease --- VIRUS DISEASES
COVID-19 --- CORONAVIRIDAE INFECTIONS
COVID-19 --- NIDOVIRALES INFECTIONS
COVID-19 --- RNA VIRUS INFECTIONS
Infectious Disease --- RNA VIRUS INFECTIONS
Lung & Chest Cancers --- LUNG DISEASES
COVID-19 --- LUNG DISEASES
Lung --- LUNG DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
Lung & Chest Cancers --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
MeSH Terms
COVID-19
CORONAVIRUS INFECTIONS
PNEUMONIA, VIRAL
PNEUMONIA
RESPIRATORY TRACT INFECTIONS
INFECTIONS
VIRUS DISEASES
CORONAVIRIDAE INFECTIONS
NIDOVIRALES INFECTIONS
RNA VIRUS INFECTIONS
LUNG DISEASES
RESPIRATORY TRACT DISEASES
SALINE SOLUTION
CRYSTALLOID SOLUTIONS
ISOTONIC SOLUTIONS
SOLUTIONS
PHARMACEUTICAL PREPARATIONS