This is a single center, randomized, double-blind, 2-arm, parallel-group study of DuACT in participants with clinical symptoms of COVID-19 that have begun within the past 72 hours prior to testing.
This is a single center, randomized, double-blind, 2-arm, parallel-group study of DuACT in participants with clinical symptoms of COVID-19 that have begun within the past 72 hours prior to testing. A confirmatory diagnosis of COVID-19 via nasopharyngeal swab, with a positive PCR result within 48 hours of testing. Consented participants who complete screening and meet study eligibility criteria will be randomized in a 1:1 ratio to receive DuACT or Placebo for 5 days. Study drugs will be administered BID for 5 days with a loading dose on Day 1. Following randomization, participants will complete a symptom questionnaire, record temperature and record oxygen saturation daily for 10 days and at day 28. A thermometer and pulse oximeter will be provided to each patient at the baseline visit (Day 1). On study days 3, 6 and 10 participants will have a clinic or home visit by a home healthcare provider. At these visits, a mid-turbinate nasal swab will be obtained, confirmation of the patient's clinical symptoms questionnaire will be completed and any adverse events will be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Sunnyside Office Park
Johannesburg, Gauteng, South Africa
Rate of decline in viral load
Rate of decline in viral load over the 10 days after randomization between participants treated with RBV and NTZ for COVID-19 and placebo
Time frame: 10 days
Time to resolution of viral load
Time to resolution of viral load, defined by reduction of virus below LLOQ and maintaining it for 2 days.
Time frame: 28 days
Comparison of proportion of subjects who are asymptomatic and symptomatic
Comparison of proportion of subjects who are asymptomatic and symptomatic at day 10
Time frame: 10 days
Rate of decline in viral load
To assess the rate of decline in viral load over days 3 and 6 after randomization
Time frame: Days 3 and 6
Change in modified NEWS-2
Assess change in modified National Early Warning System-2 items on a scale of 0 to 20. HIgher scores meaning greater clinical risk.
Time frame: 28 days
Proportion of subjects with treatment emergent adverse events
Proportion of subjects with treatment emergent adverse events leading to study drug discontinuation
Time frame: 28 days
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