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Ivermectin and Nitazoxanide Combination Therapy for COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04360356
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Kamal Mohammed Okasha, Tanta University

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).


Condition or disease Intervention/treatment Phase
COVID-19 Combination Product: Ivermectin plus Nitazoxanide Other: Standard Care Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will be a double blind randomized controlled parallel study
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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

Active Comparator: Standard care
Oxygen via ventilators
Other: Standard Care
Oxygen via Ventilators




Primary Outcome Measures :
  1. Number of Patients with COVID-19-negative PCR [ Time Frame: within 10 days ]
    COVID-19 PCR analysis


Secondary Outcome Measures :
  1. Number of patients with improved respiratory rate [ Time Frame: within 30 days ]
    improved breaths per minute for the patients

  2. Number of patients with improved PaO2 [ Time Frame: within 30 days ]
    Change in PaO2 in mmHg of the patients

  3. Number of patients with normalized Serum IL6 [ Time Frame: within 30 days ]
    Serum IL6 in pg/mL of the patients

  4. Number of patients with normalized Serum TNFα [ Time Frame: within 30 days ]
    Serum TNFα in pg/mL of the patients

  5. Number of patients with normalized Serum iron [ Time Frame: within 30 days ]
    Serum iron in microgram/dL of the patients

  6. Number of patients with normalized Serum ferritin [ Time Frame: within 30 days ]
    Serum ferritinin microgram/L of the patients

  7. Number of patients with normalized International normalized ratio "INR" for prothrombin time [ Time Frame: within 30 days ]
    International normalized ratio "INR" for prothrombin time of 2

  8. Number of patients with normalized complete blood count "CBC" [ Time Frame: within 30 days ]
    CBC for lymphocyte count in cells/microliter

  9. The Mortality rate among treated patients [ Time Frame: within 30 days ]
    Mortality rate [number of dead patients/total number of treated patients]



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04360356


Contacts
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Contact: Kamal Okasha, Md, PhD +201004706770 vp_research@unv.tanta.edu.eg
Contact: Nahla Elashmawy, Md, PhD +2010111672982 nahla.elashmawi@pharm.tanta.edu.eg

Sponsors and Collaborators
Tanta University
Investigators
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Principal Investigator: Kamal Okasha, Md, PhD Tanta University
Publications:

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Responsible Party: Prof. Dr. Kamal Mohammed Okasha, Vice-President of Postgraduate Studies and Research Affairs, Tanta University
ClinicalTrials.gov Identifier: NCT04360356    
Other Study ID Numbers: IVR/NTZ
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. Kamal Mohammed Okasha, Tanta University:
Ivermectin
Nitazoxanide
COVID-19
Additional relevant MeSH terms:
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Ivermectin
Nitazoxanide
Antiparasitic Agents
Anti-Infective Agents