Clinical trial NCT04389944: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coronavirus Disease 2019 Infectious Disease (COVID-19 Infection)
Keywords: convalescent plasma
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Serious adverse events in convalescent plasma treated patients
timeFrame: From baseline (enrolment) to 24 hours follow-up
measure: Virologic clearance in nasopharyngeal swab of convalescent plasma treated patients
timeFrame: at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28
measure: Transfer to ICU
timeFrame: at Baseline (admission to Covid-ward) until day 28
measure: in-hospital death
timeFrame: at Baseline (admission to Covid-ward) until day 28
measure: Virologic clearance in plasma of convalescent plasma treated patients
timeFrame: at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28
Secondary outcomes:
measure: Time to discharge from hospital after enrolment
timeFrame: at Baseline (admission to Covid-ward) until discharge (approx. 28 days)
measure: Humoral immune response
timeFrame: at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Blutspendezentrum SRK beider Basel, University Hospital Basel
Study officials:
affiliation: Blutspendezentrum SRK beider Basel, Universitätsspital Basel
name: Andreas Buser, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: