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CompletedNCT04486313Updated Mar 29, 2024Results posted

Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19

A Phase 3 interventional study of Nitazoxanide and Placebo in COVID-19, sponsored by Romark Laboratories L.C.. Completed at 2 sites in United States. Open to participants aged 12 Years to 120 Years. Per ClinicalTrials.gov, last updated 2024-03-29.

Sponsored by Romark Laboratories L.C. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
935
Allocation
Randomized
Ages
12 Years to 120 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 24 studies testing nitazoxanide in COVID-19 — 2 open to participants now, 2 under way, none of them phase 3. nitazoxanide · COVID-19.

Enrollment
4th of 24
935 · median 163
Started
2020
with 17 others
Phase 3
6 of 24
none open now
Registered
11th of 24
by date
Lead sponsor
5 of 24
Romark Laboratories L.C.

Among the 24 studies testing nitazoxanide in COVID-19, this one is the 4th largest by enrollment, is one of 18 that started in 2020, is one of 6 in phase 3, and was the 11th registered.

COVID-19

7,992 studies on the registry are indexed under COVID-19; 466 are open to participants now.

Browse COVID-19 studies →

Open to participants now

2 of the 24 studies testing nitazoxanide in COVID-19 are open now, in 7 countries. Recruiting first, the newest first:

By country, each count listing its studies:

Brazil1
Laos1
Nepal1
Pakistan1
South Africa1
Thailand1
United Kingdom1

All 2 open studies →

About nitazoxanide

nitazoxanide: first FDA approval 2002 (ALINIA). What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 356 COVID-19 studies recruiting now, 206 (58%) set no upper age limit and 83 (23%) stop at 75 or younger; 91 take children under 18; 135 take healthy volunteers.

This study: 12 Years to 120 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 24 studies testing nitazoxanide in COVID-19, or all of them as a file.
02

Study summary

Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19

Read the detailed description

Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19

03

Conditions studied

  • COVID-19

Browse trials for

04

Who can participate

Ages eligible
12 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female outpatients at least 12 years of age

  • Presence of clinical signs and/or symptoms consistent with worsening or stable mild or moderate COVID-19 (one of the following is required):

    1. Presence of at least two respiratory symptom domains (head, throat, nose, chest, cough) with a score of ≥2 as determined by Screening FLU-PRO OR
    2. Presence of at least one respiratory symptom domain (head, throat, nose, chest, cough) with a score of ≥2 as determined by Screening FLU-PRO with pulse rate ≥90 OR
    3. Presence of at least one respiratory symptom domain (head, throat, nose, chest, cough) with a score of ≥2 as determined by Screening FLU-PRO with respiratory rate ≥16

AND patient reported assessment that symptoms are present, the symptoms are not consistent with the subject's usual health, the symptoms interfere with daily activities, and the symptoms have worsened or remained the same relative to the previous day, as confirmed by responses to questions in the Screening FLU-PRO.

  • Onset of symptoms no more than 72 hours before enrollment in the trial. Onset of symptoms is defined as the earlier of the first time at which the subject experienced subjective fever or any respiratory symptom (head, throat, nose, chest, or cough symptoms).
  • Willing and able to provide written (including assent by legal guardian if under 18 years of age) and comply with the requirements of the protocol, including completion of the subject diary and all protocol procedures.

Exclusion criteria

Exclusion Criteria:

  • Persons with any clinical sign or symptoms suggestive of severe systemic illness with COVID-19, including the following:

    1. shortness of breath at rest,
    2. resting pulse ≥125 beats per minute,
    3. resting respiratory rate ≥30 breaths per minute, or
    4. SpO2 ≤ 93% on room air at sea level.
  • Subjects who experienced a previous episode of acute upper respiratory tract infection, otitis, bronchitis or sinusitis or received antibiotics for these conditions within two weeks prior to and including study day 1.

  • Severely immunodeficient persons including:

    1. Subjects with immunologic disorders or receiving therapy (e.g., for organ or bone marrow transplants, immunomodulatory therapies for certain diseases)
    2. Subjects with untreated (HIV) infection or treated human immunodeficiency virus (HIV) infection with a below 350 cells/mm3 in the last six months
    3. Subjects actively undergoing systemic chemotherapy or radiotherapy treatment for
    4. Subjects using as maintenance therapy for chronic conditions
  • Subjects with active respiratory allergies or subjects expected to require anti- allergy medications during the study period for respiratory allergies.
  • Females of who are either pregnant or sexually active without the use of . Female subjects of child-bearing potential that are sexually active must have a negative baseline pregnancy test and must agree to continue an acceptable method of birth control for the duration of the study and for 1 month post-treatment. A double barrier method, oral birth control pills administered for at least 2 monthly cycles prior to study drug administration, an intrauterine device (IUD), or medroxyprogesterone acetate administered intramuscularly for a minimum of one month prior to study drug administration are acceptable methods of birth control for inclusion into the study. Female subjects are considered of childbearing potential unless they are (absence of menstrual bleeding for 1 year - or 6 months if laboratory confirmation of hormonal status), or have had a hysterectomy, bilateral tubular ligation or bilateral oophorectomy.
  • Subjects with a history of COVID-19 or known to have developed anti-SARS- CoV-2 antibodies.
  • Subjects residing in the same household with another subject participating in the study.
  • Treatment with any drug or vaccine therapy within 30 days prior to screening and willing to avoid them during the course of the study.
  • Receipt of any dose of nitazoxanide within seven days prior to screening.
  • Known sensitivity to nitazoxanide or any of the comprising the study medication.
  • Subjects unable to swallow oral tablets or capsules.
  • Subjects with known severe heart, lung, neurological or other systemic disease that the Investigator believes could preclude safe participation.
  • Subjects likely or expected to require hospitalization unrelated to COVID-19 during the study period.
  • 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 including completion of the subject diary.
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
935 participants (actual)

Study arms

  • Active comparator
    Nitazoxanide

    Two nitazoxanide 300 mg tablets orally twice daily for 5 days

    Drug: Nitazoxanide · Dietary Supplement: Vitamin Super B-Complex

  • Placebo comparator
    Placebo

    Two placebo tablets orally twice daily for 5 days

    Drug: Placebo · Dietary Supplement: Vitamin Super B-Complex

Interventions

  • DrugNitazoxanide

    Two nitazoxanide 300 mg tablets administered orally twice daily with food for 5 days

    Also known as: NTZ (nitazoxanide), NT-300

  • DrugPlacebo

    Two placebo tablets administered orally twice daily with food for 5 days

  • Dietary supplementVitamin Super B-Complex

    Vitamin Super B-Complex administered orally twice daily to maintain the blind

06

What researchers measure

Primary outcomes

  1. Time to Sustained Clinical Recovery

    Time to Sustained Clinical Recovery is the time in days from the first dose of study medication to the first time at which the subject reports a decrease in total FLU-PRO score from the previous diary with assessment that symptoms are at least "somewhat better than yesterday", no oral temperature ≥100.4 F in the prior 24 hours, and no future increase in any of the FLU-PRO domains except within validated background levels.

    Time frame: Up to 21 days

Secondary outcomes

  1. Proportion of Subjects Progressing to Severe COVID-19

    Analysis of proportions of subjects with progression to severe COVID-19 illness defined as subject-reported shortness of breath at rest and blood oxygen saturation ≤93% on room air

    Time frame: Up to 21 days

Other outcomes

  1. Proportion of Subjects Positive for SARS-CoV-2 by Aptima® SARS-CoV-2 Assay at Each of Days 4 and 10

    Time frame: Day 4 and Day 10

  2. Change From Baseline in Quantitative SARS-CoV-2 RNA Measured by RT-PCR at Each of Days 4 and 10

    Time frame: Day 4 and Day 10

  3. Proportion of Subjects Requiring Hospitalization

    Analysis of proportions of subjects requiring hospitalization for any reason during the study period

    Time frame: 28 days

  4. All-Cause Mortality

    Analysis of proportions experiencing mortality from any cause during the study period

    Time frame: 28 days

07

Results

Posted Mar 29, 2024

Participant flow

Participant flow — Overall Study
MilestoneNitazoxanidePlacebo
Started472463
Completed453446
Not completed1917
Withdrew: Lost to follow-up79
Withdrew: Withdrawal by subject86
Withdrew: Physician decision11
Withdrew: Death20
Withdrew: Protocol violation11

Outcome measures

PrimaryTime to Sustained Clinical Recovery

Time to Sustained Clinical Recovery is the time in days from the first dose of study medication to the first time at which the subject reports a decrease in total FLU-PRO score from the previous diary with assessment that symptoms are at least "somewhat better than yesterday", no oral temperature ≥100.4 F in the prior 24 hours, and no future increase in any of the FLU-PRO domains except within validated background levels.

Time frame:
Up to 21 days
Reported as:
Median · days
Time to Sustained Clinical Recovery
daysNitazoxanidePlacebo
Time to Sustained Clinical Recovery13.3 (6.26 to 21)12.4 (7.18 to 21)
Statistical analysis
  • Nitazoxanide vs Placebo · Gehan-Wilcoxon Test · p = 0.8786Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness
SecondaryProportion of Subjects Progressing to Severe COVID-19

Analysis of proportions of subjects with progression to severe COVID-19 illness defined as subject-reported shortness of breath at rest and blood oxygen saturation ≤93% on room air

Time frame:
Up to 21 days
Reported as:
Number · proportion of subjects
Proportion of Subjects Progressing to Severe COVID-19
proportion of subjectsNitazoxanidePlacebo
Proportion of Subjects Progressing to Severe COVID-190.0050.036
Statistical analysis
  • Nitazoxanide vs Placebo · Cochran-Mantel-Haenszel · p = 0.0740 (Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness)
Other pre-specifiedProportion of Subjects Positive for SARS-CoV-2 by Aptima® SARS-CoV-2 Assay at Each of Days 4 and 10
Time frame:
Day 4 and Day 10
Reported as:
Number · proportion of subjects
Proportion of Subjects Positive for SARS-CoV-2 by Aptima® SARS-CoV-2 Assay at Each of Days 4 and 10
proportion of subjectsNitazoxanidePlacebo
Day 40.9080.862
Day 100.7070.662
Statistical analysis
  • Nitazoxanide vs Placebo · Cochran-Mantel-Haenszel · p = 0.4479
  • Nitazoxanide vs Placebo · Cochran-Mantel-Haenszel · p = 0.2814
Other pre-specifiedChange From Baseline in Quantitative SARS-CoV-2 RNA Measured by RT-PCR at Each of Days 4 and 10
Time frame:
Day 4 and Day 10
Reported as:
Mean · log10 RNA copies/milliliter
Change From Baseline in Quantitative SARS-CoV-2 RNA Measured by RT-PCR at Each of Days 4 and 10
log10 RNA copies/milliliterNitazoxanidePlacebo
Day 4-0.70 ± 0.118-1.02 ± 0.126
Day 10-2.49 ± 0.119-2.61 ± 0.120
Statistical analysis
  • Nitazoxanide vs Placebo · t-test, 2 sided · p = 0.0665
  • Nitazoxanide vs Placebo · t-test, 2 sided · p = 0.4974
Other pre-specifiedProportion of Subjects Requiring Hospitalization

Analysis of proportions of subjects requiring hospitalization for any reason during the study period

Time frame:
28 days
Reported as:
Number · proportion of subjects
Proportion of Subjects Requiring Hospitalization
proportion of subjectsNitazoxanidePlacebo
Proportion of Subjects Requiring Hospitalization0.0050.026
Statistical analysis
  • Nitazoxanide vs Placebo · Cochran-Mantel-Haenszel · p = 0.1771Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness
Other pre-specifiedAll-Cause Mortality

Analysis of proportions experiencing mortality from any cause during the study period

Time frame:
28 days
Reported as:
Number · proportion of subjects
All-Cause Mortality
proportion of subjectsNitazoxanidePlacebo
All-Cause Mortality0.0050.000
Statistical analysis
  • Nitazoxanide vs Placebo · Cochran-Mantel-Haenszel · p = 0.2399Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness
Post-hocTime to Sustained Recovery for Subjects With Mild Illness

Time to Sustained Clinical Recovery is the time in days from the first dose of study medication to the first time at which the subject reports a decrease in total FLU-PRO score from the previous diary with assessment that symptoms are at least "somewhat better than yesterday", no oral temperature ≥100.4 F in the prior 24 hours, and no future increase in any of the FLU-PRO domains except within validated background levels.

Time frame:
21 days
Reported as:
Median · days
Time to Sustained Recovery for Subjects With Mild Illness
daysNitazoxanidePlacebo
Time to Sustained Recovery for Subjects With Mild Illness10.3 (6.2 to 21)13.4 (7.4 to 21)
Statistical analysis
  • Nitazoxanide vs Placebo · Gehan-Wilcoxon Test · p = 0.09Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness
Post-hocTime to Return to Usual Health for Subjects With Mild Illness

Subjects completed a diary daily in the evening. The time from first dose to ability to return to usual health is the time in days from the first dose of study medication to the first time when the subject answered "Have you returned to your usual health?" with "yes" for two consecutive daily diary periods.

Time frame:
21 days
Reported as:
Median · days
Time to Return to Usual Health for Subjects With Mild Illness
daysNitazoxanidePlacebo
Time to Return to Usual Health for Subjects With Mild Illness13.2 (9.2 to 21)18.4 (11.4 to 21)
Statistical analysis
  • Nitazoxanide vs Placebo · Gehan-Wilcoxon Test · p = 0.0077Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness
Post-hocProgression to Severe COVID-19 for Subjects At Least Possibly At Increased Risk Per CDC Guidelines

Analysis of proportions of subjects with progression to severe COVID-19 illness defined as subject-reported shortness of breath at rest and blood oxygen saturation ≤93% on room air for the subgroup of subjects considered possibly at high risk per CDC guidelines

Time frame:
28 days
Reported as:
Number · proportion of subjects
Progression to Severe COVID-19 for Subjects At Least Possibly At Increased Risk Per CDC Guidelines
proportion of subjectsNitazoxanidePlacebo
Progression to Severe COVID-19 for Subjects At Least Possibly At Increased Risk Per CDC Guidelines0.0090.056
Statistical analysis
  • Nitazoxanide vs Placebo · Cochran-Mantel-Haenszel · p = 0.05Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness
Post-hocProgression to Severe COVID-19 for Subjects At Increased Risk Per CDC Guidelines

Analysis of proportions of subjects with progression to severe COVID-19 illness defined as subject-reported shortness of breath at rest and blood oxygen saturation ≤93% on room air for the subgroup of subjects considered high risk per CDC guidelines

Time frame:
28 days
Reported as:
Number · proportion of subjects
Progression to Severe COVID-19 for Subjects At Increased Risk Per CDC Guidelines
proportion of subjectsNitazoxanidePlacebo
Progression to Severe COVID-19 for Subjects At Increased Risk Per CDC Guidelines0.0090.057
Statistical analysis
  • Nitazoxanide vs Placebo · Cochran-Mantel-Haenszel · p = 0.05Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness
Post-hocProgression to Severe COVID-19 in Subjects at High Risk by FDA Guidelines

Analysis of proportions of subjects with progression to severe COVID-19 illness defined as subject-reported shortness of breath at rest and blood oxygen saturation ≤93% on room air for the subgroup of subjects considered at high risk per FDA guidelines

Time frame:
28 days
Reported as:
Number · proportion of subjects
Progression to Severe COVID-19 in Subjects at High Risk by FDA Guidelines
proportion of subjectsNitazoxanidePlacebo
Progression to Severe COVID-19 in Subjects at High Risk by FDA Guidelines0.0160.086
Statistical analysis
  • Nitazoxanide vs Placebo · Cochran-Mantel-Haenszel · p = 0.08Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness

Adverse events

Collected over 28 days. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Nitazoxanide2/472 (0.4%)2/472 (0.4%)16/472 (3.4%)
Placebo0/463 (0%)7/463 (1.5%)10/463 (2.2%)
Most frequent serious events
Most frequent serious events
EventNitazoxanidePlacebo
COVID-19 pneumoniaInfections and infestations1/4723/463
AscitesGastrointestinal disorders0/4721/463
COVID-19Infections and infestations0/4721/463
DiverticulitisInfections and infestations0/4721/463
SyncopeNervous system disorders0/4721/463
AspirationRespiratory, thoracic and mediastinal disorders1/4720/463
Most frequent other events
Most frequent other events
EventNitazoxanidePlacebo
DiarrhoeaGastrointestinal disorders16/47210/463

Baseline characteristics

Age, Continuous
Age, Continuous(years)NitazoxanidePlaceboTotal
Mean40.2 ± 14.8340.7 ± 14.6840.5 ± 14.75
Sex: Female, Male
Sex: Female, Male(Participants)NitazoxanidePlaceboTotal
Female282284566
Male190179369
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)NitazoxanidePlaceboTotal
Hispanic or Latino117112229
Not Hispanic or Latino349343692
Unknown or Not Reported6814
Race (NIH/OMB)
Race (NIH/OMB)(Participants)NitazoxanidePlaceboTotal
American Indian or Alaska Native101
Asian5712
Native Hawaiian or Other Pacific Islander6511
Black or African American414384
White404388792
More than one race112
Unknown or Not Reported141933
Height
Height(centimeters)NitazoxanidePlaceboTotal
Mean169.1 ± 10.84168.4 ± 9.96168.7 ± 10.41
Weight
Weight(kilograms)NitazoxanidePlaceboTotal
Mean88.0 ± 24.4488.5 ± 23.3688.3 ± 23.90
BMI
BMI(kilograms per meters squared)NitazoxanidePlaceboTotal
Mean30.7 ± 7.7231.1 ± 7.5130.9 ± 7.62
Time from Onset of Symptoms to Randomization
Time from Onset of Symptoms to Randomization(hours)NitazoxanidePlaceboTotal
Mean41.5 ± 15.7341.9 ± 16.7141.7 ± 16.21

3 further baseline measures are reported on the registry.

08

Study locations

2 sites
  • Invesclinic US LLC
    Fort Lauderdale, Florida 33308, United States
  • RH Medical Urgent Care
    Bronx, New York 10456, United States
09

References and documents

Publications

  • Rossignol JF, Bardin MC, Fulgencio J, Mogelnicki D, Brechot C. A randomized double-blind placebo-controlled clinical trial of nitazoxanide for treatment of mild or moderate COVID-19. EClinicalMedicine. 2022 Feb 28;45:101310. doi: 10.1016/j.eclinm.2022.101310. eCollection 2022 Mar. PubMed 35237748 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2020 to primary completion in Feb 2021, 5 months.

Results were first posted in Mar 2024, 3 years 1 month after primary completion. A results delay was requested in Feb 2022.

Of 168 industry-sponsored phase 3 interventional studies under COVID-19, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's 5 months is below that.

Counting every sponsor, half of 453 studies reached it within 9 months; a quarter within 4 and three quarters within 17.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 23, 2020
First posted
Jul 24, 2020
StartActual
Aug 13, 2020
Primary completionActual
Feb 8, 2021
CompletionActual
Feb 8, 2021
Results delay requested
Feb 10, 2022
Results first posted
Mar 29, 2024
Last update
Mar 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04486313
Lead sponsor
Romark Laboratories L.C.
Responsible party
Sponsor
First posted
Jul 24, 2020
Start date
Aug 13, 2020
Primary completion
Feb 8, 2021
Completion
Feb 8, 2021
Results posted
Mar 29, 2024
Last update
Mar 29, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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