This is a double-blind study designed to investigate the efficacy, safety and PK of a single dose of COVI-DROPS or matched placebo in outpatient adults who have tested positive for COVID-19 and are either asymptomatic or have mild symptoms.
Subjects will be randomized 2:2:1 to receive a single dose of COVI-DROPS 10 mg, COVI-DROPS 20 mg or matched placebo in a double-blind manner. Investigational product (COVI-DROPS or matched placebo) will be administered once as two separate 0.5 mL instillations (0.5 mL up each nostril). Subjects will be followed to Day 60.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
179
COVI-DROPS is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2
Diluent solution
University Hospitals of Coventry and Warwickshire Hospital Trust
Coventry, United Kingdom
Viral load change from baseline to D8
Viral load change from baseline to D8, based on reverse-transcriptase polymerase chain reaction (RT-PCR) determined COVID-19 viral titres (Log-10 copies/mL) from nasopharyngeal swabs
Time frame: Baseline to Day 8
The number of COVID-19-related urgent medically attended visits, emergency department assessments or hospitalizations through D29
The number of COVID-19-related urgent medically attended visits, emergency department assessments or hospitalizations through D29
Time frame: Baseline through Day 29
Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29
Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29
Time frame: Baseline through Day 29
Change in WHO Clinical Progression Scale score
Change in WHO Clinical Progression Scale score at D8 and D29 (score of 0-10, with lower score meaning better outcome)
Time frame: Baseline to Day 8 and Day 29
Worst WHO Clinical Progression Scale score up to D8 and from D9 to D29
Worst WHO Clinical Progression Scale score up to D8 and from D9 to D29 (score of 0-10, with lower score meaning better outcome)
Time frame: Baseline through Day 29
Viral load change from baseline to D29 based on RT-PCR determined COVID-19 viral titers (Log-10 copies/mL) from nasopharyngeal swabs
Viral load change from baseline to D29 based on RT-PCR determined COVID-19 viral titers (Log-10 copies/mL) from nasopharyngeal swabs
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline to Day 29
Change in patient-reported COVID-19 symptoms
Change in patient-reported COVID-19 symptoms as assessed using the Patient Reported Outcome Instrument for Capture of COVID-19-Related Symptoms (score of 0-50, with lower score meaning better outcome)
Time frame: Baseline to Day 8 and Day 29