COVID Clinical Trial
Official title:
Intermediate IND Severe Illness COVID-19 CP
NCT number | NCT04411602 |
Other study ID # | 1589349 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | April 7, 2020 |
Est. completion date | April 7, 2021 |
Verified date | July 2021 |
Source | Ascension South East Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 7, 2021 |
Est. primary completion date | April 7, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Ascension Providence Hospital, Novi Campus | Novi | Michigan |
United States | Ascension Providence Hospital, Southfield Campus | Southfield | Michigan |
United States | Ascension Macomb-Oakland Hospital, Warren Campus | Warren | Michigan |
Lead Sponsor | Collaborator |
---|---|
Ascension South East Michigan |
United States,
Arabi YM, Hajeer AH, Luke T, Raviprakash K, Balkhy H, Johani S, Al-Dawood A, Al-Qahtani S, Al-Omari A, Al-Hameed F, Hayden FG, Fowler R, Bouchama A, Shindo N, Al-Khairy K, Carson G, Taha Y, Sadat M, Alahmadi M. Feasibility of Using Convalescent Plasma Immunotherapy for MERS-CoV Infection, Saudi Arabia. Emerg Infect Dis. 2016 Sep;22(9):1554-61. doi: 10.3201/eid2209.151164. — View Citation
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Transfusion of patients in the ICU with convalescent plasma for COVID-19-induced respiratory failure. | Identification of patient population in ICU that are in acute respiratory failure due to COVID-19 and transfuse with convalescent plasma | Track patient progress for 28 days post initial convalescent dose. | |
Secondary | Ventilatory free days | Measure reduction in ventilator use and/or changes in mechanical ventilator parameters | Track patient progress for 28 days post initial convalescent dose. | |
Secondary | Patient mortality (including death from any cause) | 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. | Track patient progress for 28 days post initial convalescent dose. |
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