COVID-19 trials registries data warehouse

https://trialregister.nl/trial/8633

Jaap Jan Zwaginga

j.j.zwaginga@lumc.nl

2020-05-13

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. Maximal 3 days hospitalized at plasma infusion. 2. Age = 18 years and = 85 years3. SARS-CoV-2 infection: confirmed by PCR (BAL, sputum, nasal and/or pharyngeal swap) not longer than 7 days before.4. Symptoms not expected to lead to IC transfer within 6 hours of study plasma administration5. Written informed consent including storing of specimen for future testing

A potential subject who meets any of the following criteria will be excluded from participation in this study:1. Accompanying diseases other than COVID-19 with an expected survival time of less than 6 months2. Chronic severe pulmonary dysfunction like obstructive lung disease (COPD), Gold stage 4, severe emphysema, or lung fibrosis with usual interstitial pneumonia (IUP) pattern 3. Chronic heart failure NYHA >= 3 and/or pre-existing reduction of left ventricular ejection fraction to = 30% for which among others e.g. strict fluid restriction is needed 4. Clinical diagnosis of circulatory overload for which active therapy (like increased doses of diuretics) is initiated 5. Clinical judgement of deterioration in oxygenation (e.g. more than 2 L increase in additonal O2 by nose tube), respiratory rates ( e.g. more than 5 / min increase) in the 2 hours before the planned randomisation / plasma infusion 6. Signs of severe coagulopathy : thrombocytopenia by consumption ( <100 x 10e9/l) or prolongation of the PT (+3 sec) , PTT (+ 5 sec) 7. Any history of severe adverse reactions to plasma proteins8. Known deficiency of immunoglobulin A9. Pregnancy10. Breastfeeding women11. Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance

2

Leiden University Medical Center

18

85

Netherlands

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

430

Ordinal outcome at day 14 of all cause mortality; mechanical ventilation; ICU admission and long duration of hospital stay (6 days or more); with less than 6 hospitalized days as reference category.

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]