Hydroxychloroquine vs Nitazoxanide in Patients With COVID-19
Klíčová slova
Abstraktní
Popis
Introduction The current pandemic caused by the SARS-COV2 coronavirus (COVID-19) is life-threatening and is challenging the world's best health systems. Accelerated spread of this pandemia led physicians to try a variety of treatments without a well established sequence due to ignorance about this new disease. The case fatality rate has been calculated at 2.2% but there are differences depending on the country affected.
Perspective When comparing the evolution of cases between Spain and Mexico, an apparently less pronounced trend is observed in Mexico, but this may be due to underdiagnosis. In calculations by the Mexican Ministry of Health, around 6% of the patients (approximately 10,500) who contract COVID-19 could be found serious and in need of hospitalization in intensive care.
NTZx NTZx and its circulating active metabolite, tizoxanide, inhibit the replication of a wide range of viruses, both RNA and DNA. It has action against 16 strains of Influenza A virus subtypes H1N1, H3N2, H3N2v, H3N8, H5N9, H7N1 and a strain of influenza B. It also works against respiratory syncytial virus, norovirus, dengue, yellow fever, Japanese encephalitis virus, rotavirus , hepatitis B and C, even against the human immunodeficiency virus (Severe Acute Respiratory Syndrome (SARS) and Middle East respiratory syndrome (MERS).
Problem Mexico is in Phase 2 according to the World Health Organization (WHO) and more local infections due to coronaviruses are expected. To date, various COVID-19 treatment schemes are being tested, but the usefulness of none can be assured.
When reviewing the drug schemes that are being carried out in the world, it calls the attention that developing countries are not included, beyond the fact that the tested alternatives are economically inaccessible.
This clinical survey aims to test the possible utility of NTZx against COVID-19, alone or in combination with hydroxychloroquine.
Termíny
| Poslední ověření: | 03/31/2020 |
| První předloženo: | 04/06/2020 |
| Odhadovaná registrace vložena: | 04/06/2020 |
| První zveřejnění: | 04/09/2020 |
| Poslední aktualizace byla odeslána: | 04/21/2020 |
| Poslední aktualizace zveřejněna: | 04/23/2020 |
| Aktuální datum zahájení studie: | 04/05/2020 |
| Odhadované datum dokončení primární: | 08/29/2020 |
| Odhadované datum dokončení studie: | 12/29/2020 |
Stav nebo nemoc
Intervence / léčba
Drug: Nitazoxanide + hydroxychloroquine
Drug: Hydroxychloroquine
Fáze
Skupiny zbraní
| Paže | Intervence / léčba |
|---|---|
| Experimental: Nitazoxanide + hydroxychloroquine Hydroxychloroquine 400 mg PO every 12 hours for two days and then 200 mg PO every 12 hours for four days + Nitazoxanide 500 mg PO every 6 hours for six days | Drug: Nitazoxanide + hydroxychloroquine Clinical evaluation of patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using this option with two drugs |
| Active Comparator: Hydroxychloroquine Hydroxychloroquine 200 mg PO every 12 hours for 7 days |
Kritéria způsobilosti
| Věky způsobilé ke studiu | 5 Years Na 5 Years |
| Pohlaví způsobilá ke studiu | All |
| Přijímá zdravé dobrovolníky | Ano |
| Kritéria | Inclusion Criteria: - COVID-19 positive patients - Treated at the Health Institute of the State of Mexico (ISEM). - With risk factors to get complicated: age more than 60 years old, diabetes mellitus or obesity grade II or more. Exclusion Criteria: - Patients who have inherent contraindications to each drug. |
Výsledek
Primární výsledná opatření
1. Mechanical ventilation requirement [Since the diagnosis until two weeks after]
