Study of Oral Administration of Ribavirin and Nitazoxamide Versus Placebo in COVID-19

• Status: Recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Witwatersrand, South Africa
• Collaborator: SynaVir

Criteria

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