Status:
TERMINATED
Convalescent Plasma in ICU Patients With COVID-19-induced Respiratory Failure
Lead Sponsor:
Noah Merin
Collaborating Sponsors:
Johns Hopkins University
Conditions:
Covid-19
Sars-CoV2
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This study will assess the feasibility of administering multiple doses of convalescent plasma (from people who have recovered form SARS-CoV-2) to Covid-19 positive patients in the Intensive Care Unit ...
Detailed Description
Convalescent plasma is an antibody-rich product made from blood donated by people who have recovered from the disease caused by the virus. Prior experience with respiratory viruses and limited data th...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Respiratory failure requiring mechanical ventilation due to COVID-19 induced pneumonia with confirmation via SARS-CoV-2 RT-PCR testing
- PaO2/FiO2 ratio \< 300 (or SpO2/FiO2 \< 315)
- Bilateral pulmonary infiltrates
Exclusion
- Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
- In the opinion of the site investigator or primary clinical care team, anticipated to die within 48 hours.
- Acute or chronic disease/illness that, in the opinion of the site investigator, has an expected life expectancy of less than 28 days unrelated to COVID-19 induced pneumonia (e.g.; stage IV malignancy, neurodegenerative disease, anoxic brain injury, etc.)
- Use of home oxygen at baseline
- Use of home mechanical ventilation at baseline (CPAP or BIPAP without need for oxygen is NOT an exclusion)
- Respiratory failure caused by illness other than SARS-CoV-2
- Other documented uncontrolled infection.
- More than 72 hours have elapsed since first meeting inclusion criteria
- Severe DIC, TTP, or antithrombin III deficiency needing factor replacement, FFP, cryoprecipitate.
- Patient is on Warfarin and it is deemed necessary to maintain therapeutic INR (because the CP will reverse the warfarin effect).
- On dialysis at the time enrollment is considered.
- Active intracranial bleeding.
- Clinically significant myocardial ischemia.
- Prisoner or Incarceration
- Pregnancy or active breast feeding
- Has already received convalescent plasma for COVID-19 infection during current admission
- Current participation in another interventional research study
- Inability or unwillingness of subject or legal surrogate/representative to give written informed consent
Key Trial Info
Start Date :
June 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04353206
Start Date
June 27 2020
End Date
November 1 2020
Last Update
November 8 2021
Active Locations (2)
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1
8700 Beverly Blvd.
Los Angeles, California, United States, 90048
2
Johns Hopkins University
Baltimore, Maryland, United States, 21287