Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Convalescent donor plasma
  • Biological: Convalescent Plasma
    SARS-CoV-2 convalescent plasma (1-2 units; ~250-500 mL) with antibodies to SARS-CoV-21 per April 13, 2020 directive by the FDA, obtained from New York Blood Center will be administered to eligible candidate
Placebo Comparator
Lactated ringer's solution or sterile saline solution
  • Other: Saline solution
    Equivalent volume of saline solution (defined as half-,quarter-, or normal saline) will be administered to eligible candidate as a placebo control group.

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467
Contact:
Liise-Anne Pirofski, MD
l.pirofski@einsteinmed.org

More Details

Status
Recruiting
Sponsor
NYU Langone Health

Study Contact

Mila B Ortigoza, MD, PhD
803-240-8328
Mila.Ortigoza@nyulangone.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.