N/A
N=200
Efficacy and Safety of COVID-19 Convalescent Plasma
Convalescent Plasma · COVID-19 · SARS-CoV 2
Bottom Line
View on ClinicalTrials.gov: NCT04397523 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Duration of Oxygenation Support — 7.4 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- anti-SARS-CoV-2 convalescent plasma (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Institute for Transfusion Medicine of RNM
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Oxygenation Support |
7.4 | — |
| PRIMARY Hospital Length of Stay (LOS) |
11.0; 8.6; 11.1; 13.6 | 0.05 |
| PRIMARY ICU Admission |
1 | — |
| PRIMARY Number of Participants With Oxygenation Free Days |
65; 76; 103; 167 | — |
| PRIMARY Number of Participants With Serious Adverse Events |
— | — |
| SECONDARY Type of Respiratory Support |
65; 56; 35; 59; 56; 25 | — |
| SECONDARY Number of Participants With Different Clinical Outcomes Including Death, Critical Illness and Recovery |
164; 3; 22 | 0.05 |
Summary
Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection
Eligibility Criteria
Inclusion Criteria
Blood donors:
- Age: >18 and 55 kg
- Confirmed previous SARS CoV-2 infection
- Minimum 28 days after the last symptom or finishing of the isolation, or
- 21 day without symptoms from the date of the negative SARS CoV-2 test
- Written informed consent to participate in this clinical trial, to donate plasma and to store the specimen for future testing.
- Concentration of COVID-19 IgG antibodies more than 5 AU/ml (Because measurement of neutralizing antibody titers is not available now, storing of retention sample from the convalescent plasma donation is performed for determining antibody titers at a later date)
- Male donors, or female donors who have not been pregnant, or female donors who have been pregnant tested negative for HLA antibodies
- Individuals who meet all regular voluntary donor eligibility requirements
Patients/recipients:
- Age: >18 years
- Admitted to an acute care facility for the treatment of COVID-19 complications
- Patients with severe or immediately life-threatening COVID-19, or
- Patients who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease.
- Informed consent provided by the patient or healthcare proxy
Exclusion Criteria
Blood donors:
- Age : 60 years
- Female subjects who are pregnant
- HIV1,2 hepatitis B,C or syphilis infection
- Donors ineligible for regular voluntary blood donation
Patients/recipients:
- Age : <18 years
- Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products)
- Patients who received in the past 30 days immunoglobulin therapy
- Females who are pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT04397523). 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.