COVID-19Phase 3NCT04343248

Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses in Elderly Residents of Long-Term Care Facilities (LTCF)

A Phase 3 study testing Nitazoxanide and Vitamin Super B-Complex in people with COVID-19 and Viral Respiratory Illnesses, run by Romark Laboratories L.C. at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF residents. Read more about this study

Who is it for?: Ages 55 to 120 years
Conditions the study is for: COVID-19, Viral Respiratory Illnesses
What is being tested?: Nitazoxanide and Vitamin Super B-Complex
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 190 participants
Where: 4 sitesUnited States
Study dates: 12 May 2020to 1 Feb 2021
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 to 120 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female residents of LTCFs at least 55 years of age.
Willing and able to provide written informed consent and comply with the requirements of the protocol.
At least one symptomatic laboratory-confirmed COVID-19 illness identified among residents or staff of the LTCF within 10 days prior to randomization.

Who cannot join

Alzheimer's disease, dementia, or other mental incapacity which precludes comprehension of the study requirements or symptom diary.
Subjects expected to require hospitalization within the 8-week treatment and follow-up period.
Subjects with a history of COVID-19 or known to have developed anti-SARS- CoV-2 antibodies.
Subjects who experienced a previous episode of acute upper respiratory tract infection, otitis, bronchitis or sinusitis or received antibiotics for these conditions or antiviral therapy for influenza within two weeks prior to and including study day 1.
Receipt of any dose of NTZ within 7 days prior to screening.
Treatment with any investigational drug or vaccine within 30 days prior to screening or unwilling to avoid them during the course of the study.

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Known sensitivity to NTZ or any of the excipients comprising the study medication.
Subjects unable to swallow oral tablets or capsules.
Subjects taking medications considered to be major CYP2C8 substrates.
Subjects who, in the judgment of the Investigator, will be unlikely to comply with the requirements of this protocol.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Clinical Trial Specialists, Inc.
Acworth, Georgia, 30101
Centex Studies, Inc.
Houston, Texas, 77058
The Chappel Group Research
Kissimmee, Florida, 34744
Centex Studies, Inc.
Lake Charles, Louisiana, 70601

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses in Elderly Residents of Long-Term Care Facilities (LTCF)

Trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF residents.

Read the detailed description

Multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF residents.

Conditions: COVID-19, Viral Respiratory Illnesses
Being tested: Nitazoxanide, Placebo, Vitamin Super B-Complex
Keywords: COVID-19, Viral Respiratory Illnesses
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NitazoxanideDrug
Also called NTZ (nitazoxanide), NT-300
Nitazoxanide 600 mg administered orally twice daily for six weeks
PlaceboDrug
Placebo administered orally twice daily for six weeks
Vitamin Super B-ComplexDietary supplement
Vitamin Super B-Complex administered orally twice daily to maintain the blind

Study groups in NCT04343248
Study group	Role	What they receive
Nitazoxanide	Active comparator	Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks Receives: Drug: Nitazoxanide; Dietary Supplement: Vitamin Super B-Complex
Placebo	Placebo comparator	Two placebo tablets orally twice daily for 6 weeks Receives: Drug: Placebo; Dietary Supplement: Vitamin Super B-Complex

What is being measured

The primary outcome is the main question the study is designed to answer.

Symptomatic Laboratory-confirmed COVID-19
The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the 6-week treatment period. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
Measured: up to 6 weeks
Symptomatic Laboratory-confirmed VRI
The proportion of subjects with symptomatic laboratory-confirmed VRI identified after the start of treatment and before the end of the 6-week treatment period. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
Measured: up to 6 weeks

Secondary outcomes (3)

Hospitalization Due to COVID-19 or Complications Thereof
Proportion of subjects hospitalized due to COVID-19 or complications thereof. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations
Measured: Up to 6 weeks
Mortality Due to COVID-19 or Complications Thereof
Proportion of subjects experiencing mortality due to COVID-19 or complications thereof. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
Measured: Up to 6 weeks
Presence of Anti-SARS-CoV-2 at Weeks 6 or 8
Proportion of subjects with anti-SARS-CoV-2 antibodies at Week 6 or 8 visits. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
Measured: Up to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 May 20201 Feb 2021

First posted13 Apr 2020
Study start12 May 2020
Primary completion1 Feb 2021
Study completion1 Feb 2021

Why it stopped: Study recruitment was halted prematurely as widespread vaccination of the study population made completion infeasible.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COVID-19Studies 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 190 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04343248
Sponsor's protocol ID: RM08-3006
Status last verified: Jul 2024
First submitted: 8 Apr 2020
Last updated: 8 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses in Elderly Residents of Long-Term Care Facilities (LTCF)
ClinicalTrials.gov ID: NCT04343248
Acronym / sponsor ID: RM08-3006
Conditions: COVID-19, Viral Respiratory Illnesses
Keywords: COVID-19, Viral Respiratory Illnesses
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study recruitment was halted prematurely as widespread vaccination of the study population made completion infeasible.
Enrolment: 190 participants (actual)
Lead sponsor: Romark Laboratories L.C.Industry (pharma, biotech, devices)
Study start: 12 May 2020 (actual)
Primary completion: 1 Feb 2021 (actual)
Study completion: 1 Feb 2021 (actual)
First posted: 13 Apr 2020 (actual)
Results: Posted 8 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF residents.

Detailed description

Multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF residents.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Nitazoxanide	Active comparator	Drug: Nitazoxanide, Dietary Supplement: Vitamin Super B-ComplexTwo Nitazoxanide 300 mg tablets orally twice daily for 6 weeks
Placebo	Placebo comparator	Drug: Placebo, Dietary Supplement: Vitamin Super B-ComplexTwo placebo tablets orally twice daily for 6 weeks

Who may qualify

Ages: 55 to 120 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male and female residents of LTCFs at least 55 years of age.
Willing and able to provide written informed consent and comply with the requirements of the protocol.
At least one symptomatic laboratory-confirmed COVID-19 illness identified among residents or staff of the LTCF within 10 days prior to randomization.

Key exclusion criteria (10 listed)

Alzheimer's disease, dementia, or other mental incapacity which precludes comprehension of the study requirements or symptom diary.
Subjects expected to require hospitalization within the 8-week treatment and follow-up period.
Subjects with a history of COVID-19 or known to have developed anti-SARS- CoV-2 antibodies.
Subjects who experienced a previous episode of acute upper respiratory tract infection, otitis, bronchitis or sinusitis or received antibiotics for these conditions or antiviral therapy for influenza within two weeks prior to and including study day 1.
Receipt of any dose of NTZ within 7 days prior to screening.

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
NitazoxanideAlso: NTZ (nitazoxanide), NT-300Nitazoxanide 600 mg administered orally twice daily for six weeks	Drug	Nitazoxanide
PlaceboPlacebo administered orally twice daily for six weeks	Drug	Placebo
Vitamin Super B-ComplexVitamin Super B-Complex administered orally twice daily to maintain the blind	Dietary supplement	Nitazoxanide, Placebo

Primary outcome

Symptomatic Laboratory-confirmed COVID-19
Time frame: up to 6 weeks
The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the 6-week treatment period. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
Symptomatic Laboratory-confirmed VRI
Time frame: up to 6 weeks
The proportion of subjects with symptomatic laboratory-confirmed VRI identified after the start of treatment and before the end of the 6-week treatment period. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.

3 secondary outcomes

Hospitalization Due to COVID-19 or Complications Thereof
Time frame: Up to 6 weeks
Mortality Due to COVID-19 or Complications Thereof
Time frame: Up to 6 weeks
Presence of Anti-SARS-CoV-2 at Weeks 6 or 8
Time frame: Up to 8 weeks

Results and safety

Results posted to the registry on 8 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nitazoxanide	97	81
Placebo	93	78

Primary outcome: Symptomatic Laboratory-confirmed COVID-19

Time frame: up to 6 weeks. Number. Unit: proportion of subjects

Measure	Nitazoxanide n = 85	Placebo n = 81
Value	0.01	0.00

Population analysed: The primary efficacy population consists of all subjects who received at least one dose of study medication and were negative for all respiratory viruses at Baseline. Proportions rounded to the nearest hundredth.

Primary outcome: Symptomatic Laboratory-confirmed VRI

Time frame: up to 6 weeks. Number. Unit: proportion of subjects

Measure	Nitazoxanide n = 85	Placebo n = 81
Value	0.01	0.00

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nitazoxanide	10 of 97 (10.3%)	8 of 97 (8.2%)	1 of 97
Placebo	8 of 93 (8.6%)	9 of 93 (9.7%)	2 of 93

Limitations and caveats (from the sponsor): It was no longer possible to enroll eligible participants in the trial after vaccines were distributed to residents of long-term care facilities. Therefore, enrollment was terminated before the planned enrollment was completed. Study results are summarized descriptively, but no statistical analyses were performed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nitazoxanide and Vitamin Super B-Complex in people with COVID-19 and Viral Respiratory Illnesses, run by Romark Laboratories L.C. at 4 sites in United States.

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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Symptomatic Laboratory-confirmed COVID-19 (time frame: up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04343248.

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 8 Jul 2024.