CompletedNot Applicable

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

Switzerland15 participantsStarted 2020-03-31

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Serious adverse events in convalescent plasma treated patients

Timeframe: From baseline (enrolment) to 24 hours follow-up

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

Transfer to ICU

Timeframe: at Baseline (admission to Covid-ward) until day 28

in-hospital death

Timeframe: at Baseline (admission to Covid-ward) until day 28

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

Trial details

NCT IDNCT04389944

SponsorUniversity Hospital, Basel, Switzerland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-30

View on ClinicalTrials.gov More Coronavirus Disease 2019 Infectious Disease (COVID-19 Infection) trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Serious adverse events in convalescent plasma treated patients

Timeframe: From baseline (enrolment) to 24 hours follow-up

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

Transfer to ICU

Timeframe: at Baseline (admission to Covid-ward) until day 28

in-hospital death

Timeframe: at Baseline (admission to Covid-ward) until day 28

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