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

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)

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.

Study Overview

• Status: Completed
• Conditions: Coronavirus Disease 2019 Infectious Disease (COVID-19 Infection)
• Intervention / Treatment: Other: convalescent plasma application to SARS-CoV-2 infected patients

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Blutspendezentrum SRK beider Basel, University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Andreas Buser, Prof. Dr. med., Blutspendezentrum SRK beider Basel, Universitätsspital Basel

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2020
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: convalescent plasma; Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Disease Progression; COVID-19; Coronavirus Infections; Infections; Communicable Diseases; Clinical Deterioration
• Other Study ID Numbers: Req-2020-00508; me20khanna2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No