COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04501796

Not reported

Not reported

2020-08-06

Terminated

RCT

Randomized

Sequential assignment

Blind label

multi-center

Treatment

inclusion criteria: - individuals must meet all of the following criteria to be included in the study: - laboratory-confirmed sars-cov-2 infection as determined by either a documented positive molecular assay/ other commercial or public health assay in any specimen collected < 5 days prior to screening or a documented positive molecular assay ≥ 5 days prior to screening and confirmed by polymerase chain reaction (pcr) at screening. - illness of any duration with oxygen saturation > 93% at room air, heart rate ≤ 100 beats per minute at rest, and no evidence of respiratory distress with respiration rate < 20 breaths per minute. - able to provide informed consent. - aged ≥ 19 and ≤ 75 years. - absolute lymphocyte count <1,500 lymphocytes/µl. - avoid becoming pregnant or impregnate a partner through 90 days after study agent administration. females must agree to 2 methods of contraception, and males to at least one method of contraception. - not participate in any other clinical trial for an investigational therapy through day 30.

- moderate to severe hypoxic respiratory failure requiring supplemental oxygen at rest, mechanical ventilation, ecmo, or any other noninvasive ventilation modality. - crp >15 mg/l or d-dimer > 0.75 µg/ml. - estimated glomerular filtration rate (egfr) < 40 ml/min/1.73m2, or requiring dialysis. - ast/alt > 3-times uln, or total bilirubin > 1.5 times uln (except if due to gilbert's syndrome). - pregnancy or breastfeeding. - use of systemic corticosteroids or immunomodulant within 4 weeks prior to screening. - receipt of an investigational agent or investigational use of a licensed agent within 16 weeks prior to screening. - hiv infection or underlying history of known or unknown primary or acquired immunodeficiency associated with lymphopenia and/or recurrent opportunistic infections. - autoimmune disease requiring systemic treatment except for vitiligo or endocrine disease (such as diabetes, thyroid disease, and adrenal disease) controlled by replacement therapy. - malignancy requiring treatment 1 year prior to screening.

2

NeoImmuneTech

19

75

United States

Mild disease at enrollment

1: Mild disease at enrollment

7

Evaluate the safety of a single dose of NT-I7 in a dose escalation fashion

None

Phase 1

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