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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04389944
Recruitment Status : Completed
First Posted : May 15, 2020
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease Intervention/treatment Phase
Coronavirus Disease 2019 Infectious Disease (COVID-19 Infection) Other: convalescent plasma application to SARS-CoV-2 infected patients Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 31, 2020
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: convalescent plasma treatment

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
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 Measures :
  1. Serious adverse events in convalescent plasma treated patients [ Time Frame: 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

  2. Virologic clearance in nasopharyngeal swab of convalescent plasma treated patients [ Time Frame: 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

  3. Transfer to ICU [ Time Frame: at Baseline (admission to Covid-ward) until day 28 ]
    Transfer to ICU

  4. in-hospital death [ Time Frame: at Baseline (admission to Covid-ward) until day 28 ]
    in-hospital death

  5. Virologic clearance in plasma of convalescent plasma treated patients [ Time Frame: 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


Secondary Outcome Measures :
  1. Time to discharge from hospital after enrolment [ Time Frame: at Baseline (admission to Covid-ward) until discharge (approx. 28 days) ]
    Duration of hospitalisation

  2. Humoral immune response [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04389944


Locations
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Switzerland
Blutspendezentrum SRK beider Basel, University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Andreas Buser, Prof. Dr. med. Blutspendezentrum SRK beider Basel, Universitätsspital Basel
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT04389944    
Other Study ID Numbers: Req-2020-00508; me20khanna2
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
convalescent plasma
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Coronavirus Infections
Clinical Deterioration
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Disease Progression
Disease Attributes
Pathologic Processes