COVID, Severe Acute Respiratory Syndrome
Conditions
Keywords
Corona Virus, Convalescent plasma
Brief summary
Beyond supportive care, there are currently no proven therapeutic options for pneumonia due to coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19 and will be available when sufficient numbers of people have recovered. Such persons should have high titer neutralizing immunoglobulin-containing plasma.
Detailed description
Subjects will receive open-label screened plasma from COVID-19+ clinically resolved individuals (≥14 days post-resolution). Dosing of single or double plasma units (weight based \< and \> 90Kg) will be administered on days 0, 2, 4, 6, and 8 (based on plasma availability), or until futility (if either occurs before day 8) is determined by the ICU. Doses can be omitted at the discretion of the treating clinician (e.g., TRALI events are 100% donor-dependent and do not prohibit future transfusions). The study drug is the investigational product, anti-SARS-CoV-2 convalescent plasma obtained from the American Red Cross or local plasma supply (medicDal center or city/region-wide shared blood bank) from patients identified as having recovered from COVID-19. Donors and samples will be screened for infections transmitted via transfusion (e.g. HIV, HBV, HCV, WNV, HTLV-I/II, T.cruzi, ZIKV) both through the use of the uniform donor questionnaire and FDA mandated blood donor screening tests. Plasma will be collected using apheresis technology or whole blood collection in accordance with standard FDA and blood bank protocols.
Interventions
DRUGSARS-CoV-2 plasma
To determine feasibility of convalescent plasma for treating patients in the ICU with COVID-19.
Sponsors
Henry Ford Health System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Severely ill patients with COVID-19 severe respiratory distress
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Laboratory confirmed COVID-19 * Severe or Immediately life threatening COVID-19 * Dyspnea * Respiratory frequency \> 30/minute * Blood oxygen saturation \<93% * Life-threatening disease is defined as the following * Respiratory Failure. * Septic shock, and/or, * Multiple organ dysfunction or failure.
Exclusion criteria
* Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products). * Other documented uncontrolled infection. * Severe DIC needing factor replacement, FFP, cryoprecipitate. * On dialysis. * Active intracranial bleeding. * Clinically significant myocardial ischemia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transfusion of patients in the ICU with convalescent plasma for COVID-19-induced respiratory failure. | Track patient progress for 28 days post initial convalescent dose. | Identification of patient population in ICU that are in acute respiratory failure due to COVID-19 and transfuse with convalescent plasma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilatory free days | Track patient progress for 28 days post initial convalescent dose. | Measure reduction in ventilator use and/or changes in mechanical ventilator parameters |
| Patient mortality (including death from any cause) | Track patient progress for 28 days post initial convalescent dose. | Measure length of stay from the time of admission to the hospital and subsequent admission to the ICU. Document resolution of COVID-19 infection or alternatively patient death. |
Countries
United States
Outcome results
None listed