Clinical trial NCT04412486: COVID-19 Convalescent Plasma (CCP) Transfusion
Official title: An Open Label Trial of Transfusion of COVID-19 Convalescent Plasma (CCP) to Patients With Moderate to Severe COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: COVID-19
Keywords: COVID-19 Convalescent Plasma
Coronavirus
SARS-CoV-2
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: University of Mississippi Medical Center
First posted: 2020-06-02
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research study evaluates the safety and effectiveness for the use of convalescent plasma transfusion as a treatment option for novel coronavirus SARS-CoV-2 infection (COVID-19). Donors who have recovered from COVID-19 with high antibody levels to the CoV-2 virus will donate plasma at a Mississippi Blood Services facility. Recipients with COIVD-19 who have severe or life threatening conditions will receive plasma from those persons who have recovered from COVID-19.

Detailed description: The research purpose is to evaluate the safety and clinical effectiveness of transfusing one unit of banked plasma obtained from patients who have recovered from the novel coronavirus SARS-C0V-2 infection with high titers of IgG antibody to this virus transfused into patients with severe or at high risk of progressing to severe coronavirus-induced disease (COVID-19).

The research hypothesis is that COVID-19 convalescent plasma (CCP) transfusion improves outcomes in patients with COVID-19.

The use of CCP to treat serious and life threatening COVID-19 has a sound biological as well as clinical rationale to provide virus-specific immune protection in patients unable to produce and/or maintain antiviral antibodies. This treatment protocol is designed primarily to offer a rescue therapy in patients with severe and life threatening disease and explore use in patients for whom a progression to serious disease is likely. Examining the specific antibody responses to the virus in transfused patients if/when they show signs of recovery and comparing these values with those obtained before the transfusion may provide information to design more extensive trials aimed at identifying the best patient population for future use of CCP.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18
2. Clinician judged serious or life threatening COVID-19 (or at significant risk to develop serious COVID) manifested by at least one of the following:

   1. Laboratory confirmed diagnosis of SARS-CoV-2 infection
   2. Hypoxia (PaO2/FiO2 \<300, Pulse oximetry \<93% at rest
   3. Evidence of pulmonary infiltration
   4. Respiratory failure
   5. Sepsis
   6. Multiple organ dysfunction or failure (assessed by SOFA score)
3. Informed consent provided by the patient or legally authorized representative (LAR)

Exclusion Criteria:

1. Greater than 21 days from confirmed COVID-19 diagnosis
2. Receipt of pooled immunoglobulin transfusion in previous 28 days
3. History of prior reaction to transfused blood products
4. Currently enrolled in other drug trials that preclude investigational treatment with CoV-2 convalescent plasma transfusion

Primary outcomes:
measure: Change in PaO2/FiO2 after CCP transfusion.
timeFrame: 3 Days
measure: Change in pulse oximetry status after CCP transfusion.
timeFrame: 3 Days
measure: Change in aO2 after CCP transfusion.
timeFrame: 3 Days
measure: Change in respiratory rate after CCP transfusion.
timeFrame: 3 Days
measure: Change in intubation status after CCP transfusion.
timeFrame: 3 Days
Secondary outcomes:
measure: Change in Sequential Organ Failure Assessment (SOFA).
timeFrame: Days 1, 3, 7, and 28
measure: Change in 8-point ordinal clinical deterioration scale.
timeFrame: Days 1, 3, 7, and 28
measure: Length of ICU/hospital stay.
timeFrame: Days 1, 3, 7, and 28
measure: Development of plasma transfusion reactions.
timeFrame: Days 1, 3, 7, and 28
measure: Development of immune complex disorders.
timeFrame: Days 1, 3, 7, and 28
measure: Change in anti CoV-2 IgM and IgG levels.
timeFrame: Days 1, 3, 7, and 28
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Gailen D Marshall, Jr., MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: van Griensven J, Edwards T, de Lamballerie X, Semple MG, Gallian P, Baize S, Horby PW, Raoul H, Magassouba N, Antierens A, Lomas C, Faye O, Sall AA, Fransen K, Buyze J, Ravinetto R, Tiberghien P, Claeys Y, De Crop M, Lynen L, Bah EI, Smith PG, Delamou A, De Weggheleire A, Haba N; Ebola-Tx Consortium. Evaluation of Convalescent Plasma for Ebola Virus Disease in Guinea. N Engl J Med. 2016 Jan 7;374(1):33-42. doi: 10.1056/NEJMoa1511812.
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