NCT04343248

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)

Terminated Phase 3 Results posted Last updated 8 July 2024

What this trial tests

Phase 3 trial testing Nitazoxanide in COVID-19 in 190 participants. Terminated before completion.

Timeline

12 May 2020

Primary endpoint
1 February 2021

1 February 2021

Quick facts

Lead sponsor	Romark Laboratories L.C.
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	190
Start date	12 May 2020
Primary completion	1 February 2021
Estimated completion	1 February 2021
Sites	4 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 55 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.

Symptomatic Laboratory-confirmed COVID-19 Primary · 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.

Group	Value	95% CI
Nitazoxanide	0.01
Placebo	0.00

Symptomatic Laboratory-confirmed VRI Primary · 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.

Group	Value	95% CI
Nitazoxanide	0.01
Placebo	0.00

Hospitalization Due to COVID-19 or Complications Thereof Secondary · Up to 6 weeks

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

Group	Value	95% CI
Nitazoxanide	0.00
Placebo	0.00

Mortality Due to COVID-19 or Complications Thereof Secondary · Up to 6 weeks

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.

Group	Value	95% CI
Nitazoxanide	0.00
Placebo	0.00

Presence of Anti-SARS-CoV-2 at Weeks 6 or 8 Secondary · Up to 8 weeks

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.

Group	Value	95% CI
Nitazoxanide	0.21
Placebo	0.27

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: 10/97 (10%)

Deaths: 1/97

Placebo

Serious: 8/93 (9%)

Deaths: 2/93

Serious adverse events (17 terms)

Reaction	System	Nitazoxanide	Placebo
Cardiac arrest	Cardiac disorders	—	—
Cardiac failure acute	Cardiac disorders	—	—
Cardiac failure congestive	Cardiac disorders	—	—
Cardio-respiratory arrest	Cardiac disorders	—	—
Cardiovascular disorder	Cardiac disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	—	—
Cholelithiasis	Hepatobiliary disorders	—	—
Pneumonia	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Dehydration	Metabolism and nutrition disorders	—	—
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	—	—
Cerebrovascular accident	Nervous system disorders	—	—
Syncope	Nervous system disorders	—	—
Acute kidney injury	Renal and urinary disorders	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—
Peripheral ischaemia	Vascular disorders	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Nitazoxanide	Placebo
Diarrhoea	Gastrointestinal disorders	—	—
Urinary tract infection	Infections and infestations	—	—

Most-reported serious reactions: Cardiac arrest, Cardiac failure acute, Cardiac failure congestive, Cardio-respiratory arrest, Cardiovascular disorder, Diarrhoea, Lower gastrointestinal haemorrhage, Cholelithiasis.

Data from ClinicalTrials.gov NCT04343248 adverse events section.

Sponsor's own description

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

Publications & conference data

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

1. Prioritization of Anti-SARS-Cov-2 Drug Repurposing Opportunities Based on Plasma and Target Site Concentrations Derived from their Established Human Pharmacokinetics.
   Arshad U, Pertinez H, Box H, Tatham L, et al · · 2020 · cited 115× · PMID 32438446 · DOI 10.1002/cpt.1909
2. 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
3. Small molecules in the treatment of COVID-19.
   Lei S, Chen X, Wu J, Duan X, et al · · 2022 · cited 74× · PMID 36464706 · DOI 10.1038/s41392-022-01249-8
4. 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
5. COVID-19: pathophysiology, diagnosis, complications and investigational therapeutics.
   Azer SA. · · 2020 · cited 68× · PMID 32834902 · DOI 10.1016/j.nmni.2020.100738
6. Repurposing anticancer drugs for the management of COVID-19.
   El Bairi K, Trapani D, Petrillo A, Le Page C, et al · · 2020 · cited 59× · PMID 33125946 · DOI 10.1016/j.ejca.2020.09.014
7. COVID-19 Pandemic: Epidemiology, Etiology, Conventional and Non-Conventional Therapies.
   Rauf A, Abu-Izneid T, Olatunde A, Ahmed Khalil A, et al · · 2020 · cited 46× · PMID 33158234 · DOI 10.3390/ijerph17218155
8. 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