Status:
TERMINATED
A Prospective, Phase II Study to Evaluate Safety of 101-PGC-005 ('005) for Moderate to Severe COVID-19 Disease Along With Standard of Care
Lead Sponsor:
101 Therapeutics
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In December 2019, a novel pneumonia caused by a previously unknown pathogen emerged in Wuhan, China. The pathogen was soon identified as a novel coronavirus (SARS-CoV-2), which is closely related to s...
Detailed Description
This prospective Phase IIa study will evaluate the safety of '005 for moderate to severe COVID-19 disease along with Standard of Care (SOC) treatment. The Nineteen (19) eligible patients will be enrol...
Eligibility Criteria
Inclusion
- Patients willing and able to provide voluntary written informed consent and to follow the protocol specific requirements.
- Male or female patients over 18 years old.
- Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs (sample collected within 7 days prior to enrollment) who are admitted or being admitted to the hospital for a primary diagnosis of COVID-19.
- In the case of female patients of child-bearing potential, a negative blood pregnancy test prior to beginning the therapy.
- Patients intended to be hospitalized to receive SOC including dexamethasone treatment for COVID-19.
Exclusion
Key Trial Info
Start Date :
January 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2023
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT05195749
Start Date
January 13 2022
End Date
February 14 2023
Last Update
February 24 2023
Active Locations (1)
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1
The COVID-19 Unit, Rambam Health Care Campus
Haifa, Israel, 3109601