Treatment of COVID-19 using plasma repletion therapy Infections and Infestations
Conditions
Interventions
The participants in the treatment arm received plasma transfusions (up to 8 units, as tolerated, for 7 days
2 units every other day, with each unit administered 8 to 12 hours apart) in addition to the local standard of care at that time. Participants in the control arm received only what was considered the
Sponsors
Philippine Council for Health Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years 2. Presenting with dry cough, fever, dyspnea, or gastrointestinal symptoms on admission 3. Positive RT-qPCR test for SARS-CoV-2 RNA 4. Classified as a moderate or severe case of COVID-19 according to the Philippine College of Physicians (PCP)-Philippine Society for Microbiology and Infectious Diseases (PSMID) COVID-19 Guidelines and the updated COVID-19 treatment algorithm at the time of the study 4.1. Moderate COVID-19 4.1.1. With signs of non-severe pneumonia (e.g., fever, cough, dyspnea, or difficulty breathing), respiratory rate of 21-30/minute, oxygen saturation >92% on room air 4.1.2. with any of the following comorbidities: chronic hypertension, diabetes mellitus, chronic lung disease, obesity, chronic renal disease, persistent asthma 4.1.3. With PaO2/FiO2 (P/F) of >300 4.2. Severe COVID-19 4.2.1. With severe pneumonia or severe acute respiratory infection, defined as follows: fever, cough, dyspnea, respiratory rate >30 breaths/minute, severe respiratory distress 4.2.2. With *P/F of 200-300 4.2.2. oxygen saturation <92%, at FiO2 0.6
Exclusion criteria
Exclusion criteria: 1. Significant lung pathology as defined by P/F ratio<200, or obvious respiratory distress 2. Significant renal impairment as defined by eGFR<30 3. Malignancy 4. Hemodynamic instability such as refractory hypotension or shock 5. Presence of severe neurological deficits 6. Prior blood/plasma transfusion in the past two months 7. Cannot provide independent informed consent due to mental incapability
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. All-cause mortality is measured using vital status from the medical chart at discharge or at 30 days post-enrolment, whichever occurs first 2. Need for ventilator support is measured using clinical decision documented by the primary attending pulmonologist based on arterial blood gas parameters, sensorium, and overall status at any time during hospitalization up to 30 days post-enrolment 3. Prolonged hospital stay is measured using duration of hospital admission from admission and discharge dates recorded in the medical chart at discharge 4. Composite outcome is measured using the count of participants who experienced more than one of the primary outcomes using medical chart review at discharge or at 30 days post-enrolment, whichever occurs first 5. All outcomes are monitored using daily clinical assessments by the study pulmonologist with real-time access to the medical chart from enrolment until discharge or 30 days, whichever occurs first | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessed from the medical notes/chart during their course of treatment until discharge: 1. The occurrence of shock, defined as mean arterial pressure less than 60 mmHg or the use of inotropic agents (norepinephrine, epinephrine, vasopressin, dopamine, etc) for at least 24 hours 2. Multiorgan failure, defined as progression to severe COVID-19 with any two of the following: presence of acute respiratory distress syndrome (P/F ratio 2.5) | — |
Countries
Philippines
Contacts
Public ContactSullian Naval
Outcome results
None listed