NCT04364737

CONTAIN COVID-19: Convalescent Plasma to Limit COVID-19 Complications in Hospitalized Patients

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 941 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• COVID-19
• Coronavirus
• Coronavirus Infection

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2020-04-17
• Primary completion: 2021-03-29
• Completion: 2022-12-12
• First posted: 2020-04-28
• Last updated: 2023-01-26
• Results posted: 2022-04-01

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study