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NCT Number: 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

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.

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Key information

Conditions

Coronavirus Disease 2019 Infectious Disease (COVID-19 Infection) COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Blutspendezentrum SRK beider Basel, University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

convalescent plasma application to SARS-CoV-2 infected patients

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.

Primary outcomes

  1. Serious adverse events in convalescent plasma treated patients

    Time frame: 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

  2. Virologic clearance in nasopharyngeal swab of convalescent plasma treated patients

    Time frame: 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

  3. Transfer to ICU

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

    Transfer to ICU

  4. in-hospital death

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

    in-hospital death

  5. Virologic clearance in plasma of convalescent plasma treated patients

    Time frame: 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

Secondary outcomes

  1. Time to discharge from hospital after enrolment

    Time frame: at Baseline (admission to Covid-ward) until discharge (approx. 28 days)

    Duration of hospitalisation

  2. Humoral immune response

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 15, 2020
Registry last updated
Aug 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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