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N-803Wiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug1667 Observational Study Wiki 1.00
drug2176 Saline Wiki 0.38

Correlated MeSH Terms (3)

Name (Synonyms) Correlation
D007239 Infection NIH 0.06
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 Phase 1b, Randomized, Blinded, Placebo-controlled Study of the Safety of Therapeutic Treatment With an Immunomodulary Agent (N-803 in Adults With COVID-19

This is a phase 1b, randomized, blinded, placebo-controlled study in adult subjects with COVID-19. This clinical trial is designed to assess the safety and immunostimulatory activity of N-803.

NCT04385849 COVID-19 Biological: N-803 Other: Saline

Primary Outcomes

Description: AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0

Measure: Preliminary safety and efficacy evaluation of N-803 by adverse event (AE) incidence

Time: 2 weeks

Description: The 7-point ordinal scale is an assessment of the clinical status and is performed as the first assessment on each study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.

Measure: Preliminary safety and efficacy evaluation of N-803 by subject clinical status using a the 7-point ordinal scale.

Time: 2 weeks

Measure: Preliminary safety and efficacy evaluation of N-803 by changes in lymphocyte counts

Time: 2 weeks

Secondary Outcomes

Description: National Early Warning Score (NEWS) is based on 7 clinical parameters: respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, and level of consciousness.

Measure: Further evaluate efficacy of N-803 using changes to the National Early Warning Score (NEWS)

Time: 2 weeks

Measure: Further evaluate the safety of N-803 using change from baseline in hemoglobin

Time: 2 weeks

Measure: Further evaluate the safety of N-803 using change from baseline in platelets

Time: 2 weeks

Measure: Further evaluate the safety of N-803 using change from baseline in white blood cell count

Time: 2 weeks

No related HPO nodes (Using clinical trials)