Study of Oral Administration of Ribavirin and Nitazoxamide Versus Placebo in COVID-19 (DuACT)
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|ClinicalTrials.gov Identifier: NCT04563208|
Recruitment Status : Recruiting
First Posted : September 24, 2020
Last Update Posted : September 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid19 SARS-CoV Infection||Drug: Placebo Drug: DuACT||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||A Randomized, Double-Blind, Study Comparing the Efficacy, Safety, and Tolerability of Oral Administration of Ribavirin (RBV) and Nitazoxamide (NTZ)Versus Placebo in SARS-CoV-2 Virus Infected Participants (DuACT)|
|Actual Study Start Date :||December 9, 2020|
|Estimated Primary Completion Date :||February 28, 2022|
|Estimated Study Completion Date :||February 28, 2022|
Placebo Comparator: Arm A: Placebo
Placebo administered on Days 1-5
Active Comparator: Arm B: Ribavirin/Nitazoxanide (RBV/NTZ)
Ribavirin/Nitazoxanide (RBV/NTZ) administered
Day1: RBV 600 mg BID and NTZ 500 mg BID Days 2-5: RBV 400 mg BID and NTZ 500 mg BID
- Rate of decline in viral load [ Time Frame: 10 days ]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 to resolution of viral load [ Time Frame: 28 days ]Time to resolution of viral load, defined by reduction of virus below LLOQ and maintaining it for 2 days.
- Comparison of proportion of subjects who are asymptomatic and symptomatic [ Time Frame: 10 days ]Comparison of proportion of subjects who are asymptomatic and symptomatic at day 10
- Rate of decline in viral load [ Time Frame: Days 3 and 6 ]To assess the rate of decline in viral load over days 3 and 6 after randomization
- Change in modified NEWS-2 [ Time Frame: 28 days ]Assess change in modified National Early Warning System-2 items on a scale of 0 to 20. HIgher scores meaning greater clinical risk.
- Proportion of subjects with treatment emergent adverse events [ Time Frame: 28 days ]Proportion of subjects with treatment emergent adverse events leading to study drug discontinuation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04563208
|Contact: Simiso Sokhela||82 339 2322 ext +email@example.com|
|Sunnyside Office Park||Recruiting|
|Johannesburg, Gauteng, South Africa|
|Contact: Bronwyn Bosch, MBBCh +27113585300 firstname.lastname@example.org|
|Contact: Godspower Akpomiemie, MPH +2711358 5370 email@example.com|
|Principal Investigator: Simiso Sokhela, MBBCh|
|Sub-Investigator: Nomathemba Chandiwana, MBBCh|
|Sub-Investigator: Joana Woods, MBBCh|
|Principal Investigator:||Simiso Sokhela||Ezintsha|