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Hydroxychloroquine 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: NCT04361318
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:
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: Hydroxychloroquine 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
Masking: Double (Participant, Care Provider)
Masking Description: a double blind randomized controlled parallel study
Primary Purpose: Treatment
Official Title: Clinical Trial Evaluating Safety and Efficacy of Hydroxychloroquine 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: Hydroxychloroquine plus Nitazoxanide
200 mg of Hydroxychloroquine orally three times daily for 10 days plus 500 mg of Nitazoxanide orally twice daily for 6 days
Combination Product: Hydroxychloroquine plus Nitazoxanide
Both hydroxychloroquine & nitazoxanide will be administered orally to participating patients
Other Name: drug therapy

Active Comparator: Standard care
Standard care delivered in the COVID-19 isolation hospitals.
Other: Standard care
Oxygen administered via ventilator. In addition, antipyretic "paracetamol" may be added if necessary




Primary Outcome Measures :
  1. Number of patients with COVID-19-negative PCR [ Time Frame: within 10 days to become PCR negative ]
    PCR analysis of COVID-19 RNA in patients


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Confirmed cases of COVID-19 (Positive RT-PCR)
  • Newly diagnosed symptomatic patients.
  • Adults (18-65 Years old)
  • Both sexes

Exclusion Criteria:

  • Patients with abnormal liver function (ALT, AST), chronic kidney disease or dialysis (CrCl< 30 ml/min)
  • Pregnant women or women who are breastfeeding
  • Immunocompromised patients taking medication upon screening
  • Subjects with comorbid condition like hypertension, cardiovascular disease, diabetes mellites, asthma, COPD, malignancy
  • Patients having allergy to Hydroxychloroquine and/or Nitazoxanide
  • Patients with contraindication towards the study medication including retinopathy, G6PD deficiency and QT prolongation.

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): NCT04361318


Contacts
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Contact: Kamal Okasha, MD, PhD +201004706770 vp_research@unv.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: NCT04361318    
Other Study ID Numbers: HCQ/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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Prof. Dr. Kamal Mohammed Okasha, Tanta University:
Hydroxychloroquine
Nitazoxanide
COVID-19
Additional relevant MeSH terms:
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Hydroxychloroquine
Nitazoxanide
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents