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
الكلمات الدالة
نبذة مختصرة
تواريخ
| آخر التحقق: | 04/30/2020 |
| تم الإرسال لأول مرة: | 05/11/2020 |
| تم إرسال التسجيل المقدر: | 05/13/2020 |
| أول نشر: | 05/14/2020 |
| تم إرسال آخر تحديث: | 05/13/2020 |
| آخر تحديث تم نشره: | 05/14/2020 |
| تاريخ بدء الدراسة الفعلي: | 03/30/2020 |
| تاريخ الإنجاز الأساسي المقدر: | 06/29/2020 |
| التاريخ المتوقع لانتهاء الدراسة: | 06/29/2020 |
حالة أو مرض
التدخل / العلاج
Other: convalescent plasma treatment
مرحلة
مجموعات الذراع
| ذراع | التدخل / العلاج |
|---|---|
| Experimental: convalescent plasma treatment 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. | Other: convalescent plasma treatment 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. |
معايير الأهلية
| الأعمار المؤهلة للدراسة | 18 Years إلى 18 Years |
| الأجناس المؤهلة للدراسة | All |
| يقبل المتطوعين الأصحاء | نعم |
| المعايير | 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 |
النتيجة
مقاييس النتائج الأولية
1. Serious adverse events in convalescent plasma treated patients [From baseline (enrolment) to 24 hours follow-up]
2. 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]
3. Transfer to ICU [at Baseline (admission to Covid-ward) until day 28]
4. in-hospital death [at Baseline (admission to Covid-ward) until day 28]
5. 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]
مقاييس النتائج الثانوية
1. Time to discharge from hospital after enrolment [at Baseline (admission to Covid-ward) until discharge (approx. 28 days)]
2. Humoral immune response [at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28]
