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Expanded Access to Convalescent Plasma to Treat and Prevent Pulmonary Complications Associated With COVID-19

NCT04358211 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2021-03-08

No results posted yet for this study

Summary

I. Study Design: This is a single-arm feasibility study to assess the safety and efficacy of anti-SARS-CoV-2 convalescent plasma (CP) in

1. intubated, mechanically ventilated patients with confirmed COVID-19 pneumonia by chest X-ray or chest CT.
2. hospitalized patients with acute respiratory symptoms between 3 and 7 days after the onset of symptoms, with COVID-19.

II. Study Population:

1. Population 1: Mechanically ventilated intubated COVID-19 patients aged 18 years or older.
2. Population 2: Hospitalized COVID-19 patients aged ≥18 years of age with respiratory symptoms within 3 to 7 days from the beginning of illness.

III. Study Agent:

SARS-CoV-2 convalescent plasma (1-2 units; \~200-400 mL at neutralization antibody titer \>1:160.

Conditions

Interventions

BIOLOGICAL

Biological: COVID-19 convalescent plasma

One unit of ABO compatible COVID-19 convalescent plasma

Sponsors & Collaborators

  • Nakhle Saba, MD

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04358211 on ClinicalTrials.gov