Thymalfasin (Thymosin Alpha 1) to Treat COVID-19 Infection

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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 infection (secondary objectives) compared to untreated individuals in the same hospital with comparable lymphocytopenia.

After screening, hospitalized patients with COVID-19 and lymphocytopenia who meet the inclusion criteria will receive Ta1 (1.6 mg) administered subcutaneously (SC) daily for 1 week. Individuals in the control arm will be followed on the identical protocol but will not receive daily Ta1.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rhode Island Hospital
• Treatments: Thymalfasin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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