Official Title
Convalescent Plasma To Limit COVID-19 Associated Complications: A Randomized Blinded Phase 2 Study Comparing the Efficacy and Safety of Anti-SARS-CoV-2 Plasma To Placebo in COVID-19 Hospitalized Patients
Brief Summary

This is a randomized, blinded phase 2 trial to assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with a symptom onset between 3 and 7 days OR within 72 hours of hospitalization.

Detailed Description

Yale University is conducting this trial as a single site in collaboration with the New York University protocol. That trial is registered separately in (NCT04364737), with Einstein College of medicine listed as a collaborator. Yale has applied for its own IND, which is pending at the time of this registration. Yale will be using the same data capture system and central COVID specific-data safety monitoring board (DSMB) as the other sites.

Not yet recruiting
Corona Virus Infection

Biological: Convalescent Plasma
SARS-CoV-2 convalescent plasma (1-2 units, approximately 250-500 mL) with antibodies to CASR-CoV-2 will be administered.
Convalescent Donor Plasma

Biological: Lactated Ringer's Solution or Sterile Saline
Equivalent volume of lactated ringer's solution or sterile saline solution will be administered.
Lactated Ringer's Solution or Sterile Saline Solution

Eligibility Criteria

Inclusion Criteria:

1. Patients ≥18 years of age

2. Hospitalized with COVID-19 with respiratory symptoms, cough, chest pain, shortness of breath, fever, or oxygen saturation ≤ 94%, or abnormal imaging

3. Hospitalized for less than 72 hours OR within day 3 to 7 days from first signs of illness

4. Laboratory confirmed COVID-19

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. Intracranial bleed

Eligibility Gender
Eligibility Age
Minimum: 18 Years

Mahalia Desruisseaux, MD

Alessandro Santin, MD

Yale University
NYU Langone Health
Albert Einstein College of Medicine
NCT Number
MeSH Terms
Coronavirus Infections
Severe Acute Respiratory Syndrome