SARSCoV2 (COVID-19) Convalescent Plasma (CP) Expanded Access Protocol (EAP)

Status:

NO_LONGER_AVAILABLE

SARSCoV2 (COVID-19) Convalescent Plasma (CP) Expanded Access Protocol (EAP)

Lead Sponsor:

AdventHealth

Conditions:

COVID

SARSCoV2 Convalescent Plasma

Eligibility:

All Genders

6-99 years

Brief Summary

Convalescent plasma has been administered to treat different infectious diseases previously with some success. There is currently no approved and proven treatment options available for the novel coron...

Detailed Description

Eligibility Criteria

Inclusion

Ages 6 and up
Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (participants ≥ 18 years of age); or willing and able to provide assent as required per Institutional Review Board (IRB) prior to performing study procedures.
Must have laboratory confirmed COVID-19 positive test
Must have severe or immediately life-threatening COVID-19
Severe disease is defined as:
dyspnea
respiratory frequency ≥ 30/min
blood oxygen saturation ≤ 93%
partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300, and/or
lung infiltrates \> 50% within 24 to 48 hours
Life-threatening disease is defined as:
respiratory failure
septic shock, and/or
multiple organ dysfunction or failure

Exclusion

Known contraindication to transfusion or history of prior reactions to transfusion of blood products

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04374370

Last Update

May 6 2021

Active Locations (1)

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