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Novel Regimens in COVID-19 Treatment

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ClinicalTrials.gov Identifier: NCT04382846
Recruitment Status : Not yet recruiting
First Posted : May 11, 2020
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

Brief Summary:
Azithromycin has been shown to have a clinical efficacy against severe acute respiratory syndrome coronavirus 2; ivermectin has also demonstrated a remarkable experimental efficacy with a potential to be used for Coronavirus disease 2019.

Condition or disease Intervention/treatment Phase
COVID Corona Virus Infection Drug: Nitazoxanide Drug: Ivermectin Drug: Chloroquine Drug: Azithromycin Phase 3

Detailed Description:
Azithromycin has been shown to have a clinical efficacy against severe acute respiratory syndrome coronavirus; ivermectin has also demonstrated a remarkable experimental efficacy with a potential to be used for Coronavirus disease 2019. Some studies demonstrated the efficacy of combined regimen of nitazoxanide and azithromycin or ivermectin and chloroquine.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Novel Treatment Regimens in Treatment of COVID-19
Estimated Study Start Date : May 8, 2020
Estimated Primary Completion Date : December 1, 2030
Estimated Study Completion Date : December 1, 2030


Arm Intervention/treatment
Experimental: Nitazoxanide and Azithromycin
Nitazoxanide and Azithromycin as combined treatment.
Drug: Nitazoxanide
Nitazoxanide
Other Name: Parazoxanide, Nanazoxid

Drug: Azithromycin
azithromycin
Other Name: AZrolid

Experimental: Ivermectin and chloroquine
Ivermectin and chloroquine for treatment of COVID-19
Drug: Ivermectin
Nitazoxanide
Other Name: Ivermectin, Iverzin

Drug: Chloroquine
Chloroquine
Other Name: Alexoquine

Experimental: Ivermectin and Nitazoxanide
Ivermectin and Nitazoxanide for covid treatment.
Drug: Nitazoxanide
Nitazoxanide
Other Name: Parazoxanide, Nanazoxid

Drug: Ivermectin
Nitazoxanide
Other Name: Ivermectin, Iverzin

Experimental: Nitazoxanide, Ivermectin and Azithromycin
Nitazoxanide, Ivermectin and Azithromycin for COVID treatment.
Drug: Nitazoxanide
Nitazoxanide
Other Name: Parazoxanide, Nanazoxid

Drug: Ivermectin
Nitazoxanide
Other Name: Ivermectin, Iverzin

Drug: Azithromycin
azithromycin
Other Name: AZrolid




Primary Outcome Measures :
  1. Number of patients with virological cure [ Time Frame: 6 months ]
    the number of patients with virological cure



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients with COVID-19 infection

Exclusion Criteria:

  • Allergy or contraindication to the drugs.

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): NCT04382846


Contacts
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Contact: Sherief Abd-Elsalam, ass. prof. 00201147773440 sheriefabdelsalam@yahoo.com

Sponsors and Collaborators
Tanta University
Investigators
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Principal Investigator: sherief Abd-Elsalam, Ass. Prof. ass. Prof. Tropical Medicine
Publications:
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Responsible Party: Sherief Abd-Elsalam, Ass. Prof. Tropical Medicine, Tanta University
ClinicalTrials.gov Identifier: NCT04382846    
Other Study ID Numbers: tanta covid treatment
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 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
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Azithromycin
Chloroquine
Ivermectin
Nitazoxanide
Anti-Bacterial Agents
Anti-Infective Agents
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Antimalarials
Antirheumatic Agents