Coronavirus Disease 2019 Infectious Disease (COVID-19 Infection)
Conditions
Keywords
convalescent plasma, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Brief summary
This project investigates individual treatments using convalescent severe acute respiratory Syndrome Coronavirus 2 (SARS-CoV-2) plasma in SARS-CoV-2 infected patients at risk for disease progression. In addition to standard of care, SARS-CoV-2 infected patients for whom blood group compatible convalescent plasma is available and who are willing to sign the informed consent receive convalescent plasma. Only patients with moderate to severe disease at risk for transfer to intensive care unit or patients at the intensive care unit with limited treatment options will be treated.
Interventions
OTHERconvalescent plasma application to SARS-CoV-2 infected patients
In addition to standard of care, SARS-CoV-2 infected patients for whom blood group compatible convalescent plasma is available and who are willing to sign the informed consent receive convalescent plasma as follows: 200ml at enrolment and 200ml at 12-24 hours follow-up.
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for donors: * male patients who have been tested positive for SARS-CoV2 at University Hospital Basel, Switzerland or in the near surroundings more than 10 days before enrolment * 18-60 years of age * asymptomatic (thus successfully overcome COVID-19) \>14 days back * two consecutive naso-pharyngeal swabs tested negative for quantitative PCR-test for SARS-CoV-2 prior to plasma donation to demonstrate infection Resolution, or more than 28 days asymptomatic after SARS-CoV2 infection * Body weight of at least 50 kg * donor eligibility criteria according to the Swiss Red Cross Blood Transfusion Service as for regular blood donation
Exclusion criteria
for donors: * Female donors are excluded from plasma donation * Treatment with Actemra® (Tocilizumab) in the course of COVID-19 * Current hospitalization * Current or previous relevant medical conditions that pose a risk for the donor Inclusion Criteria for COVID-19 infected patients: * SARS-CoV-2 infection confirmed by PCR in respiratory secretions (naso- pharyngeal swab, broncho-alveolar lavage, sputum) * hospitalized * pulmonary infiltrates compatible with COVID-19 on CT-scan * availability of blood group compatible convalescent plasma * signed informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Virologic clearance in nasopharyngeal swab of convalescent plasma treated patients | at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28 | Change in SARS-CoV2 quantitative in nasopharyngeal swab |
| in-hospital death | at Baseline (admission to Covid-ward) until day 28 | in-hospital death |
| Virologic clearance in plasma of convalescent plasma treated patients | at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28 | Change in SARS-CoV2 quantitative in plasma |
| Serious adverse events in convalescent plasma treated patients | From baseline (enrolment) to 24 hours follow-up | Serious adverse events during the study period include transfusion reaction (fever, rash), transfusion related acute lung injury (TRAU) , transfusion associated circulatory overload (TACO) , transfusion related infection |
| Transfer to ICU | at Baseline (admission to Covid-ward) until day 28 | Transfer to ICU |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to discharge from hospital after enrolment | at Baseline (admission to Covid-ward) until discharge (approx. 28 days) | Duration of hospitalisation |
| Humoral immune response | at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28 | Rise of SARS-CoV-2 antibody titers (on day 1, 7, 14 and 28) |
Countries
Switzerland
Outcome results
None listed