Status:
TERMINATED
Thymalfasin (Thymosin Alpha 1) to Treat COVID-19 Infection
Lead Sponsor:
Rhode Island Hospital
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
It is our hypothesis that a course of Ta1 administered to hospitalized individuals with COVID-19 infection and lymphocytopenia will improve the time to recovery (primary objective) and severity of inf...
Detailed Description
Ta1 is a naturally occurring peptide that has been evaluated for its immunomodulatory activities and related therapeutic potential in several conditions and diseases, including infectious disease and ...
Eligibility Criteria
Inclusion
- Signed informed consent
- PCR positive for COVID-19 within the last 4 days
- Hospitalized
- SpO2 ≤ 93% on room air or requiring supplemental oxygen at screening (i.e. patients with severe disease)
- Lymphopenia (total lymphocyte count \< 1.5 × 109/L)
Exclusion
- Patients on mechanical ventilation
- Patients who are pregnant or breastfeeding
- Patients with multi-organ failure
- Patients with advanced malignancy receiving cytotoxic chemotherapy
- Patients with prior history of solid organ (kidney, liver, heart, lung, pancreas) or bone marrow transplant
- Patients on any other immunomodulatory therapy
- Patients receiving Plaquenil
- Patients who have participated in an investigational drug or device trial in previous 30 days
- Patients with a history of allergy or intolerance to Ta1
- Any other medical or psychiatric condition that, in the opinion of the Investigator, would compromise patient safety or interfere with the objectives of the protocol or completion of the protocol treatment
Key Trial Info
Start Date :
September 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2023
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04487444
Start Date
September 10 2020
End Date
February 3 2023
Last Update
February 14 2023
Active Locations (1)
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1
The Miriam Hospital
Providence, Rhode Island, United States, 02906