Status:
COMPLETED
Amotosalen-Ultraviolet A Pathogen-Inactivated Convalescent Plasma in Addition to Best Supportive Care and Antiviral Therapy on Clinical Deterioration in Adults Presenting With Moderate to Severe COVID-19
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Coronavirus Disease 2019 Infectious Disease (COVID-19 Infection)
Eligibility:
All Genders
18+ years
Phase:
NA
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. ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04389944
Start Date
March 31 2020
End Date
June 30 2020
Last Update
August 4 2020
Active Locations (1)
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1
Blutspendezentrum SRK beider Basel, University Hospital Basel
Basel, Switzerland, 4031