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

Romark, NCT04359680, NCT04359680, Jun 2024
ProphylaxisDouble-blind RCT · NCT04359680 · 1,407 patients · USA
Nitazoxanide for COVID-19
Romark NCT04359680 · June 2024
Lower progression with nitazoxanide
p = 0.021
RCT 1,407 healthcare workers and others at high risk of SARS-CoV-2 exposure, showing no difference in COVID-19 cases (13 in each group). There was lower symptom severity for nitazoxanide and a trend towards shorter illness duration. There is no publication, results are only available on clinicaltrials.gov, posted 3 years after completion (FDA pre-notice of noncompliance1).
Standard of Care (SOC) for COVID-19 in the study country, the USA, is very poor with very low average efficacy for approved treatments2. Only expensive, high-profit treatments were approved for early treatment. Low-cost treatments were excluded, reducing the probability of early treatment due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments.
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risk of progression, 43.5% lower, RR 0.57, p = 0.02, treatment mean 1.3 (±0.95) n=13, control mean 2.3 (±1.11) n=13.
time to perform usual activities, 50.3% lower, RR 0.50, p = 0.10, treatment mean 8.2 (±11.73) n=13, control mean 16.5 (±12.72) n=13.
time to usual health, 32.3% lower, RR 0.68, p = 0.32, treatment mean 13.2 (±16.88) n=13, control mean 19.5 (±14.58) n=13.
acute respiratory illness time, 27.5% lower, RR 0.72, p = 0.49, treatment mean 10.0 (±15.52) n=13, control mean 13.8 (±12.05) n=13.
risk of case, 2.5% lower, RR 0.97, p = 1.00, treatment 13 of 629 (2.1%), control 13 of 613 (2.1%), NNT 1854.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Romark et al., 26 Jun 2024, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 1 author, trial NCT04359680 (history).
$0 $500 $1,000+ Efficacy vs. cost for COVID-19 treatment protocols c19early.org October 2026 USA Angola Colombia Kenya Mozambique Myanmar South Africa Peru Philippines Vietnam Japan Argentina Nepal Iran Bangladesh Ethiopia Ghana Germany Mexico South Korea United Kingdom Saudi Arabia Algeria Morocco Yemen Poland Uzbekistan India China Venezuela DR Congo Madagascar Thailand Uganda Egypt Nigeria Taiwan Fiji Zambia Bosnia-Herzegovina Jordan Georgia Switzerland Dominican Republic Bolivia Côte d'Ivoire Eritrea Togo Bulgaria Greece Slovakia Iceland New Zealand Trinidad and Tobago Mongolia Czechia Belarus Israel Haiti North Macedonia Hong Kong Qatar Panama Serbia USA favored high-profit treatments.The average efficacy of treatments was very low.High-cost protocols reduce early treatment, andforgo complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%
$0 $500 $1,000+ Efficacy vs. cost for COVID-19treatment protocols worldwide c19early.org October 2026 USA Angola Colombia Kenya Mozambique Myanmar South Africa Peru Philippines Vietnam Japan Argentina Nepal Iran Bangladesh Ethiopia Ghana Germany Mexico South Korea United Kingdom Saudi Arabia Algeria Morocco Yemen Poland Uzbekistan India China Venezuela DR Congo Madagascar Thailand Uganda Egypt Taiwan Fiji Zambia Jordan Georgia Switzerland Dominican Rep. Bolivia Côte d'Ivoire Eritrea Togo Sri Lanka Bulgaria Greece Slovakia New Zealand Trinidad and Tobago Mongolia Czechia Belarus Israel North Macedonia Hong Kong Qatar Panama Serbia USA favored high-profit treatments.The average efficacy was very low.High-cost protocols reduce early treatment,and forgo complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%
Please send us corrections, updates, or comments. c19early involves the extraction of 200,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. IMA and WCH provide treatment protocols.
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