# Convalescent Plasma to Limit Coronavirus 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 pa

> **NIH NIH UL1** · ALBERT EINSTEIN COLLEGE OF MEDICINE · 2020 · $4,325,153

## Abstract

ABSTRACT
There are not any scientifically proven or approved therapies for COVID-19. Convalescent plasma (CP), which
is plasma that is obtained from people who have recovered from COVID-19, contains antibodies to SARS-CoV-
2, the virus that causes this disease. CP has a long and storied history of improving symptoms and mortality
from other pandemic diseases, such as 1918 and 2009 influenza and SARS, as well as a myriad of other toxin-
mediated and infectious diseases. Thus, CP is a rationally based and readily available therapeutic option for
COVID-19. There are thousands of people who have recovered from COVID-19 in the New York City area who
have donated their plasma to help others who are suffering from this disease. This project is a collaborative
randomized blinded placebo-controlled trial to evaluate the efficacy of treatment with CP in hospitalized patients
with COVID-19 that is being conducted at three New York University (NYU) Langone Health hospitals in
Manhattan, Brooklyn and Long Island, Bellevue Hospital Center, and three Montefiore Medical Center (MMC)
hospitals in the Bronx. We designed and launched this trial as the pandemic surged in NYC by rapidly developing
a multicenter, well-powered Phase 2 trial via regional collaborations established by Einstein-Montefiore and
NYU-Langone CTSAs with support from the New York Blood Center (NYBC). The hypothesis underpinning the
trial is that compared to placebo, administration of CP will avert respiratory deterioration, the main cause of death
in patients with COVID-19. The specific aims of this project are: 1) To examine whether CP decreases the
likelihood of respiratory deterioration in patients hospitalized for COVID-19 compared to placebo (saline solution,
SS) at 14 days from administration, and 2) To identify associations between quantitative and qualitative SARS-
CoV-2 antibody levels and clinical outcomes in patients hospitalized for COVID-19 who receive CP and placebo.
The public health benefit of proof of CP efficacy against COVID-19, which has already caused 338,000 infections
and 21,845 deaths in the United States and 187,250 infections and 1,127 deaths in New York City would be a
tremendous and public health advance that could save thousands of lives.

## Key facts

- **NIH application ID:** 10166008
- **Project number:** 3UL1TR002556-04S1
- **Recipient organization:** ALBERT EINSTEIN COLLEGE OF MEDICINE
- **Principal Investigator:** MARLA J KELLER
- **Activity code:** UL1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $4,325,153
- **Award type:** 3
- **Project period:** 2020-07-08 → 2023-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10166008

## Citation

> US National Institutes of Health, RePORTER application 10166008, Convalescent Plasma to Limit Coronavirus 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 pa (3UL1TR002556-04S1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10166008. Licensed CC0.

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