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

Study Overview
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Brief Summary
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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.

Official Title
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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 Coronavirus Disease 2019 Infectious Disease (COVID-19)

Conditions
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Coronavirus Disease 2019 Infectious Disease (COVID-19 Infection)

Intervention / Treatment
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* Other: convalescent plasma application to SARS-CoV-2 infected patients


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: convalescent plasma treatment<br>After confirmation of negative SARS-CoV-2 polymerase chain reaction (PCR) in two consecutive nasal swabs or 28 days after resolution of symptoms, donor check is performed and plasma donation occurs by apheresis. The plasma is photochemically pathogen reduced using the INTERCEPT Blood System. 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. | Other: convalescent plasma application to SARS-CoV-2 infected patients<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious adverse events in convalescent plasma treated patients | 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 | From baseline (enrolment) to 24 hours follow-up | 
| Virologic clearance in nasopharyngeal swab of convalescent plasma treated patients | Change in SARS-CoV2 quantitative in nasopharyngeal swab | at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28 | 
| Transfer to ICU | Transfer to ICU | at Baseline (admission to Covid-ward) until day 28 | 
| in-hospital death | in-hospital death | at Baseline (admission to Covid-ward) until day 28 | 
| Virologic clearance in plasma of convalescent plasma treated patients | Change in SARS-CoV2 quantitative in plasma | at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to discharge from hospital after enrolment | Duration of hospitalisation | at Baseline (admission to Covid-ward) until discharge (approx. 28 days) | 
| Humoral immune response | Rise of SARS-CoV-2 antibody titers (on day 1, 7, 14 and 28) | at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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convalescent plasma, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)