Convalescent Plasma in ICU Patients With COVID-19-induced Respiratory Failure

Stopped early · Early Phase 1

Conditions studied: Covid-19, Sars-CoV2

In brief

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 receiving mechanical ventilation. Donor plasma will not be obtained under this protocol, but all plasma used will follow FDA guidelines for Investigational COVID-19 Convalescent Plasma use. Patients may receive single or double plasma units infused on days 0, 3, and 6. This decision may be based on availability of blood plasma. The primary objective of this study is feasibility. Feasibility will be assessed based on the proportion of subjects who consent and receive at least one dose of convalescent plasma. The study will be declared 'feasible' if at least 80% of subjects who consent receive at least one dose. The secondary study endpoint is overall survival at day 60 after first dose of convalescent plasma. Respiratory status and overall clinical status will be reviewed during follow up on days 14, 28, and 60.

Key facts

Study ID

NCT04353206

Run by

Noah Merin

People needed

6

Starts

2020-06-27

Expected to finish

2020-11-01

Last updated by the study team

2021-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 8700 Beverly Blvd. — Los Angeles, California, United States
• Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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