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

NCT ID: NCT04389944

Last Updated: 2020-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-31
• Study Completion Date: 2020-06-30

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.

Conditions

Coronavirus Disease 2019 Infectious Disease (COVID-19 Infection)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

convalescent plasma application to SARS-CoV-2 infected patients

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Buser, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Blutspendezentrum SRK beider Basel, Universitätsspital Basel

Locations

Blutspendezentrum SRK beider Basel, University Hospital Basel

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

Req-2020-00508; me20khanna2

Identifier Type: -

Identifier Source: org_study_id