Covid19Phase 2DuACTNCT04563208
Study of Oral Administration of Ribavirin and Nitazoxamide Versus Placebo in COVID-19
A Phase 2 study testing DuACT in people with Covid19 and SARS-CoV Infection, run by University of Witwatersrand, South Africa at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid19, SARS-CoV Infection
- What is being tested?
- DuACT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Africa
- Study dates
- 9 Dec 2020to 28 Feb 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed a current EC approved informed consent form
- 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:
- Presence of fever at time of screening of ≥ 38.0°C (≥ 100.0°F) and/or
- 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
- Presence of at least one respiratory symptom (e.g. cough, chest tightness or sore throat) and/or
- Diagnosis of COVID-19 with a positive PCR in the past 48 hours
Who cannot join
- Pregnant or lactating females
- Critically ill with presence of one or more of the following signs:
- difficulty breathing or shortness of breath
- need for admission to a hospital or an intensive care unit,
- acute respiratory failure requiring intubation/mechanical ventilation,
- signs of shock including hypotension
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- Oxygen saturation < 92 %
- Any clinically significant screening laboratory results that are greater than 5 times the upper limit of normal.
- Estimated GFR < 50 mL/min/1.73 m2 (calculated using either Modification of Diet in Renal Disease (MDRD) or Cockcroft Gualt
- Known genetic hemoglobinopathy (e.g., thalassemia major or sickle cell anemia) or autoimmune hemolytic anemia
- Hemoglobin less than 10 gm/dL or hematocrit < 30 %
- Retinal eye disease
- Known chronic kidney disease, stage - 5 or receiving dialysis
- Inability to tolerate oral medications
- Allergy or prior adverse reaction to either ribavirin or nitazoxanide
- QTc interval > 450 mSEC for men and women
- History of Torsade de Pointes VT or prior cardiac arrest or congenital long QT interval
- Current treatment with histamine-2 receptor antagonists (H2 blockers) and/or Protein Pump Inhibitors and throughout the study.
- Have been vaccinated against COVID-19
- Have participated in a clinical study in the past 30 days
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Covid19, SARS-CoV Infection
- Being tested
- Placebo, DuACT
- Keywords
- Ribavirin, Nitazoxanide, SARS-CoV-2
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo administered on Days 1-5
DuACTDrug
Day1: RBV 600 mg BID and NTZ 500 mg BID Days 2-5: RBV 400 mg BID and NTZ 500 mg BID
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Placebo | Placebo comparator | Placebo administered Receives: Drug: Placebo |
| Arm B: Ribavirin/Nitazoxanide (RBV/NTZ) | Active comparator | Ribavirin/Nitazoxanide (RBV/NTZ) administered Receives: Drug: DuACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 days
Secondary outcomes (5)
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.
Measured: 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
Measured: 10 days
Rate of decline in viral load
To assess the rate of decline in viral load over days 3 and 6 after randomization
Measured: 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.
Measured: 28 days
Proportion of subjects with treatment emergent adverse events
Proportion of subjects with treatment emergent adverse events leading to study drug discontinuation
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start9 Dec 2020
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Witwatersrand, South Africa
- Sponsor type
- University, hospital or other
- Collaborators
- SynaVir
- Responsible party
- Principal investigator, Professor Francois Venter, University of Witwatersrand, South Africa
- Investigators
- Simiso Sokhela, Principal investigator, Ezintsha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563208
- Sponsor's protocol ID
- DUACT-101
- Acronym
- DuACT
- Status last verified
- Jul 2022
- First submitted
- 21 Sep 2020
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04563208
- Acronym / sponsor ID
- DuACT / DUACT-101
- Conditions
- Covid19, SARS-CoV Infection
- Keywords
- Ribavirin, Nitazoxanide, SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Witwatersrand, South AfricaUniversity, hospital or other
- Collaborators
- SynaVir
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Placebo | Placebo comparator | Drug: PlaceboPlacebo administered |
| Arm B: Ribavirin/Nitazoxanide (RBV/NTZ) | Active comparator | Drug: DuACTRibavirin/Nitazoxanide (RBV/NTZ) administered |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed a current EC approved informed consent form
- 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:
- Diagnosis of COVID-19 with a positive PCR in the past 48 hours
Key exclusion criteria (21 listed)
- Pregnant or lactating females
- Critically ill with presence of one or more of the following signs:
- Any clinically significant screening laboratory results that are greater than 5 times the upper limit of normal.
- Estimated GFR < 50 mL/min/1.73 m2 (calculated using either Modification of Diet in Renal Disease (MDRD) or Cockcroft Gualt
- Known genetic hemoglobinopathy (e.g., thalassemia major or sickle cell anemia) or autoimmune hemolytic anemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo administered on Days 1-5 | Drug | Arm A: Placebo |
| DuACTDay1: RBV 600 mg BID and NTZ 500 mg BID Days 2-5: RBV 400 mg BID and NTZ 500 mg BID | Drug | Arm B: Ribavirin/Nitazoxanide (RBV/NTZ) |
Primary outcome
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
5 secondary outcomes
Time to resolution of viral load
Time frame: 28 days
Comparison of proportion of subjects who are asymptomatic and symptomatic
Time frame: 10 days
Rate of decline in viral load
Time frame: Days 3 and 6
Change in modified NEWS-2
Time frame: 28 days
Proportion of subjects with treatment emergent adverse events
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simiso Sokhela principal investigator
Ezintsha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DuACT in people with Covid19 and SARS-CoV Infection, run by University of Witwatersrand, South Africa at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of decline in viral load (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.