NCT04359680 is a Phase 3 clinical trial of Nitazoxanide in COVID-19, sponsored by Romark Laboratories L.C..

Who is sponsoring NCT04359680?

NCT04359680 is sponsored by Romark Laboratories L.C..

What drugs are being tested in NCT04359680?

Interventions in NCT04359680: Nitazoxanide, Placebo, Vitamin Super B-Complex.

What condition does NCT04359680 study?

NCT04359680 studies COVID-19, Viral Respiratory Illnesses.

Is NCT04359680 still recruiting?

NCT04359680 is currently completed. Last updated 26 June 2024.

Are results published for NCT04359680?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-06-26 · How we verify

NCT04359680

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection

Completed Phase 3 Results posted Last updated 26 June 2024

What this trial tests

Phase 3 trial testing Nitazoxanide in COVID-19 in 1,407 participants. Completed in 7 April 2021.

Timeline

13 May 2020

Primary endpoint
7 April 2021

7 April 2021

Quick facts

Lead sponsor	Romark Laboratories L.C.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	1,407
Start date	13 May 2020
Primary completion	7 April 2021
Estimated completion	7 April 2021
Sites	26 locations across United States

Drugs / interventions tested

Nitazoxanide (NITAZOXANIDE) — full drug profile →
Placebo
Vitamin Super B-Complex

Conditions studied

COVID-19 — all drugs for COVID-19 →
Viral Respiratory Illnesses — all drugs for Viral Respiratory Illnesses →

Sponsor

Romark Laboratories L.C. — full company profile →

Who can join

Adults 18 to 120, any sex, with COVID-19 or Viral Respiratory Illnesses. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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. Primary · Up to 6 weeks

Group	Value	95% CI
Nitazoxanide	0.02
Placebo	0.02

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. Primary · Up to 6 weeks

Group	Value	95% CI
Nitazoxanide	0.05
Placebo	0.05

Proportion Experiencing Mortality Due to COVID-19 or Complications Thereof Secondary · Up to 8 weeks

Note: statistical analysis not performed because no events occurred.

Group	Value	95% CI
Nitazoxanide	0
Placebo	0

Proportion With Anti-SARS-CoV-2 Antibodies at Either of the Week 6 or Week 8 Visits Secondary · Up to 8 weeks

Group	Value	95% CI
Nitazoxanide	0.17
Placebo	0.19

Days Not at Usual Health Due to COVID-19 Secondary · Up to 56 days

Descriptive statistics of the number of days patients with symptomatic COVID-19 report not being at usual health due to COVID-19

Group	Value	95% CI
Nitazoxanide	13.2	± 16.88
Placebo	19.5	± 14.58

Days Unable to Perform Usual Activities Due to COVID-19 Secondary · Up to 56 days

Descriptive statistics of the number of days patients with symptomatic COVID-19 report being unable to perform usual activities due to COVID-19

Group	Value	95% CI
Nitazoxanide	8.2	± 11.73
Placebo	16.5	± 12.72

Days Meeting Acute Respiratory Illness Symptom Severity Criteria Due to COVID-19 Secondary · Up to 56 days

Descriptive statistics of the number of days patients with symptomatic COVID-19 met the protocol-specified acute respiratory illness symptom severity criteria due to COVID-19

Group	Value	95% CI
Nitazoxanide	10.0	± 15.52
Placebo	13.8	± 12.05

Maximum Symptom Severity Due to COVID-19 Secondary · Up to 56 days

Descriptive statistics of the maximum symptom severity reported by patients with symptomatic COVID-19. The global assessment of symptom severity was reported by patients as "absent", "mild", "moderate", "severe", or "very severe" and coded as 0, 1, 2, 3, or 4, respectively.

Group	Value	95% CI
Nitazoxanide	1.3	± 0.95
Placebo	2.3	± 1.11

Days Not At Usual Health Due to VRI Secondary · Up to 56 days

Descriptive statistics of the number of days patients with symptomatic viral respiratory illness (VRI) report not being at usual health due to VRI

Group	Value	95% CI
Nitazoxanide	9.9	± 12.19
Placebo	14.4	± 14.44

Days Unable to Perform Usual Activities Due to VRI Secondary · Up to 56 days

Descriptive statistics of the number of days patients with symptomatic viral respiratory illness (VRI) report being unable to perform usual activities due to VRI

Group	Value	95% CI
Nitazoxanide	5.9	± 8.85
Placebo	9.7	± 11.61

Days Meeting Acute Respiratory Illness Symptom Severity Criteria Due to VRI Secondary · Up to 56 days

Descriptive statistics of the number of days patients with symptomatic viral respiratory illness (VRI) met the protocol-specified acute respiratory illness symptom severity criteria due to VRI

Group	Value	95% CI
Nitazoxanide	7.3	± 10.97
Placebo	11.4	± 12.73

Maximum Symptom Severity Due to VRI Secondary · Up to 56 days

Descriptive statistics of the maximum symptom severity reported by patients with symptomatic viral respiratory illness (VRI). The global assessment of symptom severity was reported by patients as "absent", "mild", "moderate", "severe", or "very severe" and coded as 0, 1, 2, 3, or 4, respectively.

Group	Value	95% CI
Nitazoxanide	1.6	± 0.98
Placebo	1.9	± 1.01

Adverse events — posted to ClinicalTrials.gov

Time frame: 8 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Nitazoxanide

Serious: 3/686 (0%)

Deaths: 0/686

Placebo

Serious: 6/663 (1%)

Deaths: 0/663

Serious adverse events (9 terms)

Reaction	System	Nitazoxanide	Placebo
Myocardial infarction	Cardiac disorders	—	—
Syncope	Cardiac disorders	—	—
Abdominal hernia	Gastrointestinal disorders	—	—
Cholelithiasis	Hepatobiliary disorders	—	—
Drug-induced liver injury	Hepatobiliary disorders	—	—
Epididymitis	Infections and infestations	—	—
Ankle fracture	Injury, poisoning and procedural complications	—	—
Lower limb fracture	Injury, poisoning and procedural complications	—	—
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—

Most-reported serious reactions: Myocardial infarction, Syncope, Abdominal hernia, Cholelithiasis, Drug-induced liver injury, Epididymitis, Ankle fracture, Lower limb fracture.

Data from ClinicalTrials.gov NCT04359680 adverse events section.

Sponsor's own description

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Drug repurposing approach to fight COVID-19.
Singh TU, Parida S, Lingaraju MC, Kesavan M, et al · · 2020 · cited 299× · PMID 32889701 · DOI 10.1007/s43440-020-00155-6
Comprehensive analysis of drugs to treat SARS‑CoV‑2 infection: Mechanistic insights into current COVID‑19 therapies (Review).
Nitulescu GM, Paunescu H, Moschos SA, Petrakis D, et al · · 2020 · cited 93× · PMID 32468014 · DOI 10.3892/ijmm.2020.4608
A review of potential suggested drugs for coronavirus disease (COVID-19) treatment.
Tarighi P, Eftekhari S, Chizari M, Sabernavaei M, et al · · 2021 · cited 80× · PMID 33482181 · DOI 10.1016/j.ejphar.2021.173890
A review on possible mechanistic insights of Nitazoxanide for repurposing in COVID-19.
Lokhande AS, Devarajan PV. · · 2021 · cited 69× · PMID 33227285 · DOI 10.1016/j.ejphar.2020.173748
Therapeutics for COVID-19 and post COVID-19 complications: An update.
Basu D, Chavda VP, Mehta AA. · · 2022 · cited 44× · PMID 35136858 · DOI 10.1016/j.crphar.2022.100086
Novel therapeutic approaches for treatment of COVID-19.
Hossein-Khannazer N, Shokoohian B, Shpichka A, Aghdaei HA, et al · · 2020 · cited 36× · PMID 32494931 · DOI 10.1007/s00109-020-01927-6
2-Deoxy-D-Glucose and its Derivatives for the COVID-19 Treatment: An Update.
Huang Z, Chavda VP, Vora LK, Gajjar N, et al · · 2022 · cited 29× · PMID 35496298 · DOI 10.3389/fphar.2022.899633
Combination therapies for COVID-19: An overview of the clinical trials landscape.
Akinbolade S, Coughlan D, Fairbairn R, McConkey G, et al · · 2022 · cited 29× · PMID 34558094 · DOI 10.1111/bcp.15089

Verify or expand the search:

Other trials of Nitazoxanide

Trials testing the same drug.

NCT06993974 — Nitazoxanide in Patients With Ulcerative Colitis · Phase 2 · recruiting
NCT07086937 — Efficacy of Nitazoxanide Based Therapy vs Standard Triple Therapy in H-pylori in Children · NA · completed
NCT06010992 — Nitazoxanide as Adjuvant Therapy in Type 2 Diabetes Mellitus · Phase 2 · unknown
NCT05368935 — Nitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects · Phase 1 · completed
NCT05116826 — Nitazoxanide Pharmacokinetic Parameters in Hepatic Impaired Patients · Phase 1 · completed

Other recruiting trials for COVID-19

Currently open trials in the same condition.

NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults · Phase 1 · active not recruiting
NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting

Other Romark Laboratories L.C. trials

Trials by the same sponsor.

NCT04489381 — Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection · Phase 3 · terminated
NCT04486313 — Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19 · Phase 3 · completed
NCT04343248 — Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Vira · Phase 3 · terminated
NCT03905655 — Study of Nitazoxanide Compared to Placebo in Subjects With HBeAG-Negative Chronic Hepatitis B · Phase 2 · completed
NCT03605862 — Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04359680 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Romark Laboratories L.C.
Last refreshed: 26 June 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04359680.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing