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.
Drug: Placebo
Placebo administered on Days 1-5
Drug: DuACT
Day1: RBV 600 mg BID and NTZ 500 mg BID Days 2-5: RBV 400 mg BID and NTZ 500 mg BID
Inclusion Criteria:
1. Signed a current EC approved informed consent form
2. Male or female participants between 18 and 75 years of age, inclusive diagnosis of
SARS-CoV-2 infection, with all of the following, with onset of any within the 72 hours
prior to testing:
1. Presence of fever at time of screening of ≥ 38.0°C (≥ 100.0°F) and/or
2. Presence of at least one constitutional symptom associated with Covid-19 (e.g.
headache, myalgia, malaise, or fatigue, rash, diarrhea, loss or alteration of
taste/smell) of any severity, and/or
3. Presence of at least one respiratory symptom (e.g. cough, chest tightness or sore
throat) and/or
3. Diagnosis of COVID-19 with a positive PCR in the past 48 hours
Exclusion Criteria:
1. Pregnant or lactating females
2. Critically ill with presence of one or more of the following signs:
1. difficulty breathing or shortness of breath
2. need for admission to a hospital or an intensive care unit,
3. acute respiratory failure requiring intubation/mechanical ventilation,
4. signs of shock including hypotension
5. Oxygen saturation < 92 %
3. Any clinically significant screening laboratory results that are greater than 5 times
the upper limit of normal.
4. Estimated GFR < 50 mL/min/1.73 m2 (calculated using either Modification of Diet in
Renal Disease (MDRD) or Cockcroft Gualt
5. Known genetic hemoglobinopathy (e.g., thalassemia major or sickle cell anemia) or
autoimmune hemolytic anemia
6. Hemoglobin less than 10 gm/dL or hematocrit < 30 %
7. Retinal eye disease
8. Known chronic kidney disease, stage - 5 or receiving dialysis
9. Inability to tolerate oral medications
10. Allergy or prior adverse reaction to either ribavirin or nitazoxanide
11. QTc interval > 450 mSEC for men and women
12. History of Torsade de Pointes VT or prior cardiac arrest or congenital long QT
interval
13. Current treatment with histamine-2 receptor antagonists (H2 blockers) and/or Protein
Pump Inhibitors and throughout the study.
14. Have been vaccinated against COVID-19
15. Have participated in a clinical study in the past 30 days
16. Any physical, mental, or social condition, drug/alcohol use, history of illness or
laboratory abnormality that in the investigator's judgment might interfere with study
procedures or the ability of the subject to adhere to and complete the study
Sunnyside Office Park
Johannesburg, Gauteng, South Africa
Simiso Sokhela, Principal Investigator
Ezintsha