Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • COVID-19
  • Sars Cov 2
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

PRIMARY OBJECTIVE: I. Determine change in viral load at day 6 compared to baseline between two regimens to treat COVID-19 and a contemporaneous control group. SECONDARY OBJECTIVES: I. Time to resolution of symptoms (symptom questionnaire) II. Change in the fever curve resulting in shorter time to af...

PRIMARY OBJECTIVE: I. Determine change in viral load at day 6 compared to baseline between two regimens to treat COVID-19 and a contemporaneous control group. SECONDARY OBJECTIVES: I. Time to resolution of symptoms (symptom questionnaire) II. Change in the fever curve resulting in shorter time to afebrile for 48 hours III. Normalization of vital signs IV. Time to discharge (if hospitalized) V. Assessment of agent toxicity as measured by standard metrics VI. Collection of throat swab and blood for viral load, presence of IgM or IgG antibodies VII. If feasible on samples collected for quantitative PCR decrease in virus shedding (in oropharyngeal secretions) VIII. Measures of cytokines in blood including IL6, IL-8, TNF, INF IX. Routine standard of care labs obtained as part of the care of these patients such as differential white count, CRP, troponin and LFTs will be analyzed for correlative trends

Tracking Information

NCT #
NCT04336332
Collaborators
Not Provided
Investigators
Principal Investigator: Sabiha Hussain, MD Rutgers, The State University of New Jersey Study Chair: Steven K. Libutti, MD, FACS Rutgers Cancer Institute of New Jersey
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