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

Not Applicable

Completed

• Conditions: Coronavirus Disease 2019 Infectious Disease (COVID-19 Infection)
• Interventions: Other: convalescent plasma application to SARS-CoV-2 infected patients

• Registration Number: NCT04389944
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-31
• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-14
• Study First Posted: 2020-05-15
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
convalescent plasma treatment	convalescent plasma application to SARS-CoV-2 infected patients	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.

Primary Outcome Measures

Name	Time	Method
Serious adverse events in convalescent plasma treated patients	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
Virologic clearance in nasopharyngeal swab of convalescent plasma treated patients	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
Transfer to ICU	at Baseline (admission to Covid-ward) until day 28	Transfer to ICU
Virologic clearance in plasma of convalescent plasma treated patients	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
in-hospital death	at Baseline (admission to Covid-ward) until day 28	in-hospital death

Secondary Outcome Measures

Name	Time	Method
Humoral immune response	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)
Time to discharge from hospital after enrolment	at Baseline (admission to Covid-ward) until discharge (approx. 28 days)	Duration of hospitalisation

Trial Locations

Locations (1)

Blutspendezentrum SRK beider Basel, University Hospital Basel; 🇨🇭 Basel, Switzerland