Ivermectin 200 mcg/kg once orally on empty stomach plus Nitazoxanide 500 mg twice daily orally with meal for 6 days

COVID-19

Ivermectin plus Nitazoxanide

Standard Care

Ivermectin and Nitazoxanide Combination Therapy for COVID-19

Clinical Trial Evaluating Safety and Efficacy of Ivermectin and Nitazoxanide Combination as Adjuvant Therapy in COVID-19 Newly Diagnosed Egyptian Patients: A Tanta University Hope

improved breaths per minute for the patients

Serum iron in microgram/dL of the patients

Serum ferritinin microgram/L of the patients

International normalized ratio "INR" for prothrombin time of 2

CBC for lymphocyte count in cells/microliter

Mortality rate [number of dead patients/total number of treated patients]

Prof. Dr. Kamal Mohammed Okasha

Vice-President of Postgraduate Studies and Research Affairs

Tanta University

This study will be a double blind randomized controlled parallel study

Benznidazole (100 mg and 50 mg) tablets by mouth, every 12 hours for 8 weeks.
Three E1224 Placebo 100 mg capsules by mouth, everyday on days 1 to 3, followed by three E1224 Placebo 100 mg capsules by mouth, once weekly (starting on week 2) for 7 weeks.

Benznidazole (100 mg and 50 mg) tablets by mouth, every 12 hours for 4 weeks, followed by:
Benznidazole Placebo (100 mg and 50 mg) tablets by mouth, every 12 hours for 4 weeks.
Three E1224 Placebo 100 mg capsules by mouth, everyday on days 1 to 3, followed by three E1224 Placebo 100 mg capsules by mouth, once weekly (starting on week 2) for 7 weeks.

Benznidazole (100 mg and 50 mg) tablets by mouth, every 12 hours for 2 weeks, followed by:
Benznidazole Placebo (100 mg and 50 mg) tablets by mouth, every 12 hours for 6 weeks.
Three E1224 Placebo 100 mg capsules by mouth, everyday on days 1 to 3, followed by three E1224 Placebo 100 mg capsules by mouth, once weekly (starting on week 2) for 7 weeks.

Benznidazole (100 mg and 50 mg) tablets and Benznidazole Placebo (100 mg and 50 mg) tablets by mouth, in two separate daily doses for 4 weeks, followed by:
Benznidazole Placebo (100 mg and 50 mg) tablets by mouth, every 12 hours for 4 weeks.
Three E1224 Placebo 100 mg capsules by mouth, everyday on days 1 to 3, followed by three E1224 Placebo 100 mg capsules by mouth, once weekly (starting on week 2) for 7 weeks.

Benznidazole (100 mg and 50 mg) tablets and Benznidazole Placebo (100 mg and 50 mg) tablets by mouth, in two separate daily doses for 4 weeks, followed by:
Benznidazole Placebo (100 mg and 50 mg) tablets by mouth, every 12 hours for 4 weeks.
Three E1224 100 mg capsules by mouth, everyday on days 1 to 3, followed by three E1224 100 mg capsules by mouth, once weekly (starting on week 2) for 7 weeks. (total dose: 3000 mg).

Benznidazole (100 mg and 50 mg) tablets by mouth, once weekly for 8 weeks (total 8 days of intermittent treatment) and Benznidazole Placebo (100 mg and 50 mg) tablets by mouth, in the other 6 days of the week for 8 weeks
Three E1224 100 mg capsules by mouth, everyday on days 1 to 3, followed by three E1224 100 mg capsules by mouth, once weekly (starting on week 2) for 7 weeks. (total dose: 3000 mg).

Benznidazole Placebo (100 mg and 50mg) tablets by mouth, every 12 hours for 8 weeks.
Three E1224 Placebo 100 mg capsules by mouth, everyday on days 1 to 3, followed by three E1224 Placebo 100 mg capsules by mouth, once weekly (starting on week 2) for 7 weeks.

Chagas Disease

Benznidazole

E1224

E1224 Placebo

Benznidazole Placebo

Plataforma de Atención Integral de Pacientes con Enfermedad de Chagas.

BENDITA BEnznidazole New Doses Improved Treatment and Associations

Phase 2 Randomized, Multicenter, Safety and Efficacy Trial to Evaluate Different Oral Benznidazole Monotherapy and Benznidazole/E1224 Combination Regimens for the Treatment of Adult Patients With Chronic Indeterminate Chagas Disease

To determine the efficacy of different dosing regimens of orally administered BZN and BZN/E1224 in individuals with chronic indeterminate CD, by determining the proportion of patients who convert from positive to negative in serial, qualitative PCR test results (3 negative PCR results) at end of treatment (EOT) and sustain parasitological clearance at 6 months of follow-up, in comparison to placebo.
For efficacy assessments, the EOT of each treatment arm will be defined in accordance to the duration of the treatment regimen. Sustained response will be assessed in all treatment arms using the same number of PCR samples (i.e., EOT; 12 weeks; 4 and 6 months).

The safety consists the description of each serious adverse event and adverse event (preferred term) per treatment group and classified by system organ. EkG and Laboratory abnormalities will be considered as Adverse Events.

To assess the sustained parasitological response at week 12 and 12 months for each of the regimens, in comparison with placebo.
To determine the efficacy of the different dosing regimens in individuals with chronic indeterminate CD, by determining the proportion of patients who convert from positive to negative in serial, qualitative PCR test results (3 negative PCR results) at EOT, in comparison with placebo.

To assess the time to parasite DNA clearance (below the Quantitative Polymerase Chain Reaction (qPCR) Limit of Detection (LOD) for each of the regimens.
To assess the time to sustained clearance of parasitemia for each of the regimens.

To measure the reduction in parasite load at weeks 1, 2, 3, 4, 6, 10, 12 and at 4, 6 and 12 months follow-up, as measured by quantitative PCR.

To evaluate serological response by conventional serology at 12 months of follow up and non-conventional serology at week 12, 4, 6 and 12 months of follow up.

Characterization of population pharmacokinetic parameters of orally administered BZN and BZN/E1224

To characterize the population pharmacokinetic parameters of orally administered BZN and BZN/E1224

Drugs for Neglected Diseases

3 intralesional injections of antimony at D1, D3 and D7

Liquid nitrogen until freezing at DF1 and D14

topical treatment 3 times a day during 21 days with an emollient cream

Leishmaniasis

Cutaneous Leishmaniasis

pentavalent antimony

Frozing of lesions with liquid nitrogen ad D1 and D14

cryotherapy

topical emollient crean 3 times a day during 21 days

placebo cream

CUNETROP - Universidad Mayor de San Simon

Hospital Dermatologico de Jorochito

Intralesional Antimony for Bolivian Cutaneous Leishmaniasis

Short Course of Intralesional Antimony for Bolivian Cutaneous Leishmaniasis

100% epithelization, complete resolution of swelling and infiltration

Ealuation of clinical findings and changes in OKG, lipase and SGOT in patients receiving intralesional antimony

antiparasitic/misselijkheid

Ivermectin and Nitazoxanide Combination Therapy for COVID-19

BENDITA BEnznidazole New Doses Improved Treatment and Associations

Intralesional Antimony for Bolivian Cutaneous Leishmaniasis

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