Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04563208
Recruitment Status : Recruiting
First Posted : September 24, 2020
Last Update Posted : September 16, 2021
Sponsor:
Collaborator:
SynaVir
Information provided by (Responsible Party):
Professor Francois Venter, University of Witwatersrand, South Africa

Brief 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.

Condition or disease Intervention/treatment Phase
Covid19 SARS-CoV Infection Drug: Placebo Drug: DuACT Phase 2

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: Double-blind
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Arm A: Placebo
Placebo administered
Drug: Placebo
Placebo administered on Days 1-5

Active Comparator: Arm B: Ribavirin/Nitazoxanide (RBV/NTZ)
Ribavirin/Nitazoxanide (RBV/NTZ) administered
Drug: DuACT
Day1: RBV 600 mg BID and NTZ 500 mg BID Days 2-5: RBV 400 mg BID and NTZ 500 mg BID




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Simiso Sokhela 82 339 2322 ext +27 ssokhela@ezintsha.org

Locations
Layout table for location information
South Africa
Sunnyside Office Park Recruiting
Johannesburg, Gauteng, South Africa
Contact: Bronwyn Bosch, MBBCh    +27113585300    bbosch@ezintsha.org   
Contact: Godspower Akpomiemie, MPH    +2711358 5370    gakpomiemie@ezintsha.org   
Principal Investigator: Simiso Sokhela, MBBCh         
Sub-Investigator: Nomathemba Chandiwana, MBBCh         
Sub-Investigator: Joana Woods, MBBCh         
Sponsors and Collaborators
University of Witwatersrand, South Africa
SynaVir
Investigators
Layout table for investigator information
Principal Investigator: Simiso Sokhela Ezintsha
Layout table for additonal information
Responsible Party: Professor Francois Venter, Divisional Director: Ezintsha, University of Witwatersrand, South Africa
ClinicalTrials.gov Identifier: NCT04563208    
Other Study ID Numbers: DUACT-101
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Professor Francois Venter, University of Witwatersrand, South Africa:
Ribavirin
Nitazoxanide
SARS-CoV-2
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases