Brief Summary

This treatment protocol is designed to provide convalescent plasma as a therapeutic option for patients diagnosed with and hospitalized for COVID-19 with symptoms ranging from mild to life-threatening.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach

8 countries

38 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2020

Completed

4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed

Last Updated

May 6, 2023

Status Verified

May 1, 2023

First QC Date

April 20, 2020

Last Update Submit

May 4, 2023

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2

Interventions

Anti-Sars-CoV-2 Convalescent PlasmaBIOLOGICAL

Fresh frozen plasma, Plasma Frozen for 24 hours (PF-24), or Liquid plasma

Eligibility Criteria

Sexall

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

A patient must meet the following criteria to be included in this protocol:
DoD personnel covered by the Force Health Protection (FHP) program under the Department of Defense Instruction (DoDI) 6200.02 (active duty service members OCONUS and CONUS) and non-DoD personnel who may be treated for COVID-19 at Military Treatment Facilities (MTFs) under the authority of DoDI 6200.03, including Military Health System (MHS) beneficiaries, patients admitted to MTFs, and patients cared for under defense support for civilian authorities (e.g. hospital ships, field hospitals deployed for the COVID-19 response).
Laboratory confirmed COVID-19 diagnosis
Both PCR and antigen tests are considered to be diagnostic
Serum antibody titer testing is not considered to be diagnostic, as patients who recently recovered from COVID-19 will still test positive)
Hospitalized with symptoms ranging from mild to life-threatening
Informed consent provided by the patient or legally authorized representative (LAR), except in situations described in 21 CFR 50.23
Understands and agrees to comply with planned protocol procedures
In general, adults with SARS-CoV-2 infection can be grouped into the following severity of illness categories. However, the criteria for each category may overlap or vary across clinical guidelines and clinical trials, and a patient's clinical status may change over time.
Asymptomatic or Presymptomatic Infection: Individuals who test positive for SARS-CoV-2 using a virologic test (i.e., a nucleic acid amplification test or an antigen test) but who have no symptoms that are consistent with COVID-19.
Mild Illness: Individuals who have any of the various signs and symptoms of COVID-19 (eg, fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging.
Moderate Illness: Individuals who show evidence of lower respiratory disease during clinical assessment or imaging and who have saturation of oxygen (SpO2) ≥94% on room air at sea level.
Severe Illness: Individuals who have SpO2 \<94% on room air at sea level, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) \<300 mm Hg, respiratory frequency \>30 breaths/min, or lung infiltrates \>50%.
Critical Illness: Individuals who have respiratory failure, septic shock, and/or multiple organ dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

U.S. Army Medical Research and Development Commandlead

Study Sites (38)

Naval Hospital Camp Pendleton

Oceanside, California, 92055, United States

Location

Navy Medical Center San Diego

San Diego, California, 92134, United States

Location

USS Abraham Lincoln