COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04487444

Eleftherios Mylonakis

Not reported

2020-07-27

Terminated

RCT

Randomized

Parallel

Open label

single-center

Treatment

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)

- 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

2

Rhode Island Hospital

18

100

United States

Severe disease at enrollment

6: Severe disease at enrollment

56

Time to recovery (free of respiratory failure)

None

Phase 2

[{"arm_notes": "", "treatment_id": 1288, "treatment_name": "Thymalfasin", "treatment_type": "Hormones", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]