Hydroxychloroquine and Nitazoxanide Combination Therapy for COVID-19
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ClinicalTrials.gov Identifier: NCT04361318 |
Recruitment Status : Unknown
Verified April 2020 by Prof. Dr. Kamal Mohammed Okasha, Tanta University.
Recruitment status was: Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 | Combination Product: Hydroxychloroquine plus Nitazoxanide Other: Standard care | Phase 2 Phase 3 |

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 |

Arm | Intervention/treatment |
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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
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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.
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Other: Standard care
Oxygen administered via ventilator. In addition, antipyretic "paracetamol" may be added if necessary |
- 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
- Number of patients with improved respiratory rate [ Time Frame: within 30 days ]improved breaths per minute for the patients
- Number of patients with improved PaO2 [ Time Frame: within 30 days ]Change in PaO2 in mmHg of the patients
- Number of patients with normalized Serum IL6 [ Time Frame: within 30 days ]Serum IL6 in pg/mL of the patients
- Number of patients with normalized Serum TNFα [ Time Frame: within 30 days ]Serum TNFα in pg/mL of the patients
- Number of patients with normalized Serum iron [ Time Frame: within 30 days ]Serum iron in microgram/dL of the patients
- Number of patients with normalized Serum ferritin [ Time Frame: within 30 days ]Serum ferritinin microgram/L of the patients
- 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
- Number of patients with normalized complete blood count "CBC" [ Time Frame: within 30 days ]CBC for lymphocyte count in cells/microliter
- The Mortality rate among treated patients [ Time Frame: within 30 days ]Mortality rate [number of dead patients/total number of treated patients]

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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 |
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.

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
Contact: Kamal Okasha, MD, PhD | +201004706770 | vp_research@unv.tanta.edu.eg |
Principal Investigator: | Kamal Okasha, MD, PhD | Tanta University |
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 |
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 |
Hydroxychloroquine Nitazoxanide COVID-19 |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases |
Respiratory Tract Diseases Hydroxychloroquine Nitazoxanide Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents |