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Clinical Trials/NL-OMON23835
NL-OMON23835
Recruiting
Not Applicable

Convalescent plasma compared to standard plasma for treatment of hospitalized non-ICU patients with COVID-19 infections

eiden University Medical Center0 sites430 target enrollmentTBD
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ConditionsCOVID-19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
eiden University Medical Center
Enrollment
430
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
eiden University Medical Center

Eligibility Criteria

Inclusion Criteria

  • •1\.Maximal 3 days hospitalized at plasma infusion.
  • •2\.Age \= 18 years and \= 85 years
  • •3\.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 administration
  • •5\.Written informed consent including storing of specimen for future testing

Exclusion Criteria

  • •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 months
  • •2\.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 proteins
  • •8\.Known deficiency of immunoglobulin A
  • •9\.Pregnancy

Outcomes

Primary Outcomes

Not specified

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