Phase 1
Completed N=32
COVID-19 Convalescent Plasma for Mechanically Ventilated Population
Source: ClinicalTrials.gov NCT04388527 ↗Enrolled (actual)
32
Serious AEs
71.9%
Results posted
Apr 2022
Primary outcomePrimary: Participants With Serious Adverse Events. — 22 Participants
Summary
The purpose of this study is to see if this plasma can be safely used in humans with COVID-19 and to see if it can improve patients' health when they are sick with COVID-19.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Serious Adverse Events. |
22 | — |
| PRIMARY Time to Clinical Improvement. |
11 | — |
| SECONDARY Clinical Status Assessment, Using 8-point Ordinal Scale, of Convalescent Plasma Administration |
12.5 | — |
| SECONDARY Clinical Status Assessment Using the National Early Warning Score (NEWS) of Convalescent Plasma Administration |
10 | — |
| SECONDARY Incidence of New Oxygenation Use up to Day 29 of Convalescent Plasma Administration |
— | — |
| SECONDARY Duration of New Oxygen Use up to Day 29 of Convalescent Plasma Administration |
— | — |
| SECONDARY Oxygenation |
16 | — |
| SECONDARY Non-invasive Ventilation/High Flow Oxygen Days up to Day 29 of Convalescent Plasma Administration. |
— | — |
| SECONDARY Number of Subjects With at Least One Day of Non-invasive Ventilation/High Flow Oxygen up to Day 29 of Convalescent Plasma Administration. |
13 | — |
| SECONDARY Duration of Non-invasive Ventilation/High Flow Oxygen up to Day 29 of Convalescent Plasma Administration. |
— | — |
| SECONDARY Invasive Ventilation/ Extracorporeal Membrane Oxygenation(ECMO) Days |
11.5 | — |
| SECONDARY Incidence of New Mechanical Ventilation or ECMO Use of Convalescent Plasma Administration. |
— | — |
| SECONDARY Duration of New Mechanical Ventilation or ECMO Use of Convalescent Plasma Administration. |
— | — |
| SECONDARY Duration of Hospitalization |
20 | — |
| SECONDARY Mortality |
14 | — |
| SECONDARY Serious Adverse Events (SAEs) Through Day 29 of Convalescent Plasma Administration. |
— | — |
| SECONDARY Number of Subjects With at Least One Grade 3 and Grade 4 Clinical and/or Laboratory Adverse Events Through Day 29 of Convalescent Plasma Administration. |
32 | — |
| SECONDARY Changes in WBC With Differential Through Day 29 of Convalescent Plasma Administration. |
1.25 | — |
| SECONDARY Changes in Hemoglobin Measurement Through Day 29 of Convalescent Plasma Administration. |
-0.65 | — |
| SECONDARY Changes in Platelets Measurement Through Day 29 of Convalescent Plasma Administration. |
24 | — |
| SECONDARY Changes in Creatinine Measurement Through Day 29 of Convalescent Plasma Administration. |
-0.39 | — |
| SECONDARY Changes in Glucose Measurement Through Day 29 of Convalescent Plasma Administration. |
-36.00 | — |
| SECONDARY Changes in Total Bilirubin Measurement Through Day 29 of Convalescent Plasma Administration. |
0.00 | — |
| SECONDARY Changes in ALT Measurement Through Day 29 of Convalescent Plasma Administration. |
-3.00 | — |
| SECONDARY Changes in AST Measurement Through Day 29 of Convalescent Plasma Administration. |
-7.50 | — |
| SECONDARY Changes in PT Measurement Through Day 29 of Convalescent Plasma Administration. |
-0.050 | — |
Eligibility Criteria
Inclusion Criteria
- Adult ≥18 years of age
- Laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other authorized or approved assay in any specimen collected within 72 hours prior to enrollment. Note - An exception must be requested to the Sponsor if≥72 hours since positive test.
- Hospitalized, on invasive mechanical ventilation or ECMO, consistent with a clinical status assessment 8-point ordinal scale severity score of 7.
- Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g., chest x-ray or CT scan).
- Patient or proxy is willing and able to provide written informed consent and comply with all protocol requirements.
Exclusion Criteria
- Contraindication to transfusion (e.g., severe volume overload, history of severe allergic reaction to blood products), as judged by the investigator.
- Clinical suspicion that the etiology of acute illness (acute decompensation) is primarily due to a condition other than COVID-19
- Receipt of other investigational therapy as a part of another clinical trial. a. Note: investigational therapies used as part of clinical care, (eg, remdesivir, hydroxychloroquine) are permissible.
Data sourced from ClinicalTrials.gov (NCT04388527). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.