Status:
UNKNOWN
Allocetra-OTS in COVID-19
Lead Sponsor:
Hadassah Medical Organization
Conditions:
COVID-19
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
This is a multi-center, open-label study evaluating the safety of Allocetra-OTS, in 5 subjects with severe COVID-19 and respiratory dysfunction. Subjects, who will be identified as suffering from COVI...
Detailed Description
Study Rationale COVID-19, the name given to the clinical syndrome associated with the newly recognized virus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has become pandemic with a mo...
Eligibility Criteria
Inclusion
- Five subjects, male or female \> 18 and \< 80-year-old diagnosed with respiratory dysfunction and COVID-19, as defined below:
- Laboratory confirmation of SARS-CoV-2 infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source.
- Patients classified as severe according to NIH severity classification.
- All patients will be treated by treating physicians with subcutaneous (S.C.) Clexane, at a minimal dose of 40 mg a day
Exclusion
- Pregnancy, lactation, and childbearing potential woman who are not willing to use acceptable contraceptives measures for the entire study duration.
- Combined with other organ failures (need organ support not including respirator), including Stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated glomerular filtration rate (eGFR) \< 30)
- Patients with malignant tumor, other serious systemic diseases and psychosis.
- Patients who are participating in other clinical trials or treated with any experimental agents that may contradict this trial (i.e, biologics)
- Co-Infection of HIV, tuberculosis.
- Known immunocompromised state or medications known to be immunosuppressive (see concomitant prohibited medications).
- Intubated patients (due to inability to sign an informed consent)
- Patients with P/F ratio of \<150 or a change in status of eligibility manifested by a rapid decline of P/F ratio between eligibility status and actual drug delivery.
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04513470
Start Date
August 1 2020
End Date
February 1 2021
Last Update
October 19 2020
Active Locations (1)
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1
Hadassah Medical Center
Jerusalem, Israel, 91120