Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The concept of this clinical trial is built on the collection of convalescent plasma from individuals who had recovered from documented infection with SARS-CoV-2, to be used for patients with- or at high risk of progression to- severe/life-threatening clinical conditions due to SARS-CoV-2 infection.
An informed consent is required to join this clinical trial; patients will be transfused with one or two units of ABO compatible convalescent plasma. Those patients will be followed up and the clinical and laboratory data will be compiled, including adverse events related to the administration of convalescent plasma (CP).
Other data to be collected retrospectively will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated, and survival till discharge from an acute care facility).
This study will be done inside Cairo university hospitals, it will involve a number of CP donors who were recovered from COVID-19 infection and were treated at Cairo University isolation hospital. The CP donation process will take place at CUH blood bank ,the number of the donors will be determined at the end of the study as it will vary according to the donation process .
The study will also include sixty seven /life threatening COVID-19 patients admitted to Cairo University isolation hospital.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STANDARD OF COARE | Active Comparator | Receiving SOC |
|
| STANDARD CP DOSE Adm (Two infusions) | Experimental | Two infusions 48 hours apart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Convalescent Plasma | Biological | Convalescent Plasma |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of hospitalization/Recovery status | Decrease of hospital days of safety until discharge | 2-3 weeks |
Not provided
Not provided
Inclusion Criteria:
Severe disease is defined as:
Life-threatening disease is defined as:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nermeen ElDesouky, MD PhD | Contact | 01006029006 | nermeen.eldesoukey@kasralainy.edu.eg |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University Hospital | Recruiting | Cairo | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
This study is a prospective, single-institution, single-arm, study using a historical control group for comparison. Open label, 2 arms: SOC and SOC+CP
Not provided
Not provided
Not provided
Not provided
| Standard of Care |
| Drug |
Standard of Care drugs administered as per Cairo University ICU protocol |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |