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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 COVID-19

Primary Purpose

Coronavirus Disease 2019 Infectious Disease (COVID-19 Infection)

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
convalescent plasma application to SARS-CoV-2 infected patients
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus Disease 2019 Infectious Disease (COVID-19 Infection) focused on measuring convalescent plasma, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Blutspendezentrum SRK beider Basel, University Hospital Basel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

convalescent plasma treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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
Virologic clearance in nasopharyngeal swab of convalescent plasma treated patients
Change in SARS-CoV2 quantitative in nasopharyngeal swab
Transfer to ICU
Transfer to ICU
in-hospital death
in-hospital death
Virologic clearance in plasma of convalescent plasma treated patients
Change in SARS-CoV2 quantitative in plasma

Secondary Outcome Measures

Time to discharge from hospital after enrolment
Duration of hospitalisation
Humoral immune response
Rise of SARS-CoV-2 antibody titers (on day 1, 7, 14 and 28)

Full Information

First Posted
May 12, 2020
Last Updated
August 3, 2020
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT04389944
Brief Title
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
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 31, 2020 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Disease 2019 Infectious Disease (COVID-19 Infection)
Keywords
convalescent plasma, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
convalescent plasma treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
convalescent plasma application to SARS-CoV-2 infected patients
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serious adverse events in convalescent plasma treated patients
Description
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
Time Frame
From baseline (enrolment) to 24 hours follow-up
Title
Virologic clearance in nasopharyngeal swab of convalescent plasma treated patients
Description
Change in SARS-CoV2 quantitative in nasopharyngeal swab
Time Frame
at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28
Title
Transfer to ICU
Description
Transfer to ICU
Time Frame
at Baseline (admission to Covid-ward) until day 28
Title
in-hospital death
Description
in-hospital death
Time Frame
at Baseline (admission to Covid-ward) until day 28
Title
Virologic clearance in plasma of convalescent plasma treated patients
Description
Change in SARS-CoV2 quantitative in plasma
Time Frame
at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28
Secondary Outcome Measure Information:
Title
Time to discharge from hospital after enrolment
Description
Duration of hospitalisation
Time Frame
at Baseline (admission to Covid-ward) until discharge (approx. 28 days)
Title
Humoral immune response
Description
Rise of SARS-CoV-2 antibody titers (on day 1, 7, 14 and 28)
Time Frame
at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Buser, Prof. Dr. med.
Organizational Affiliation
Blutspendezentrum SRK beider Basel, Universitätsspital Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Blutspendezentrum SRK beider Basel, University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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