Ivermectin and Nitazoxanide Combination Therapy for COVID-19

NCT04360356 | Unknown Phase 2 DMC

• 1 other identifier: IVR/NTZ
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Research Background and Rationale In December 2019, a new infectious respiratory disease emerged in Wuhan, Hubei province, China. An initial cluster of infections was linked to Huanan seafood market, potentially due to animal contact. Subsequently, human-to-human transmission occurred and the disease, now termed coronavirus disease 19 (COVID-19) rapidly spread within China and all over the world. A novel coronavirus, SARS-coronavirus 2 (SARS-CoV-2), which is closely related to SARS-CoV, was detected in patients and is believed to be the etiologic agent of the new lung disease. The causative agent of the current COVID-19 pandemic, SARS-CoV-2, is a single stranded positive sense RNA virus that is closely related to severe acute respiratory syndrome coronavirus (SARS-CoV).

Conditions

COVID-19

Keywords

Ivermectin; Nitazoxanide; COVID-19

Outcome Measures

Primary Outcomes (1)

• Number of Patients with COVID-19-negative PCR

  COVID-19 PCR analysis

  within 10 days

Secondary Outcomes (9)

• Number of patients with improved respiratory rate

  within 30 days

• Number of patients with improved PaO2

  within 30 days

• Number of patients with normalized Serum IL6

  within 30 days

• Number of patients with normalized Serum TNFα

  within 30 days

• Number of patients with normalized Serum iron

  within 30 days

Study Arms (2)

Ivermectin plus Nitazoxanide

EXPERIMENTAL

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

Combination Product: Ivermectin plus Nitazoxanide

Standard care

ACTIVE COMPARATOR

Oxygen via ventilators

Other: Standard Care

Interventions

Ivermectin plus Nitazoxanide COMBINATION_PRODUCT

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

Ivermectin plus Nitazoxanide

Standard Care OTHER

Oxygen via Ventilators

Standard care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult symptomatic patients (18-65 years old), both sexes, and PCR positive in nasopharyngeal sample at admission.

You may not qualify if:

• Abnormal liver function (ALT, AST), chronic kidney disease or dialysis (CrCl\< 30 ml/min), immunocompromised patients taking medication upon screening, subjects on warfarin or dicumarol therapy and those with comorbid condition like hypertension, hypotension, cardiovascular disease, diabetes mellitus, asthma, COPD, seizures, coagulation disorder and malignancy.
• Patients will be also excluded if they had a known allergy to Ivermectin and/or Nitazoxanide, and those with contraindication towards the study medication.
• Pregnant women or women who are breastfeeding will be also excluded.

Sponsors & Collaborators

• Tanta University: lead

Related Publications (16)

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MeSH Terms

Conditions

COVID-19

Interventions

Ivermectin; nitazoxanide; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Kamal Okasha, Md, PhD

  Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kamal Okasha, Md, PhD

CONTACT

+201004706770; vp_research@unv.tanta.edu.eg

Nahla Elashmawy, Md, PhD

CONTACT

+2010111672982; nahla.elashmawi@pharm.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-President of Postgraduate Studies and Research Affairs

Model Details: This study will be a double blind randomized controlled parallel study

Study Record Dates

• First Submitted: April 19, 2020
• First Posted: April 24, 2020
• Study Start: May 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share