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Efficacay of Chloroquine or Hydroxychloroquine in COVID-19 Treatment

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: NCT04353336
Recruitment Status : Recruiting
First Posted : April 20, 2020
Last Update Posted : December 3, 2020
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

Study Description
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Brief Summary:
Chloroquine or hydroxychloroquine in COVID-19 treatment

Condition or disease Intervention/treatment Phase
COVID-19 Coronavirus Infection Drug: Chloroquine or Hydroxychloroquine Phase 2 Phase 3

Detailed Description:
Clinical Study Evaluating the Efficacy of Chloroquine or hydroxychloroquine in COVID-19 treatment
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study Evaluating the Efficacy of Chloroquine or Hydroxychloroquine in COVID-19 Treatment
Actual Study Start Date : March 23, 2020
Estimated Primary Completion Date : September 23, 2030
Estimated Study Completion Date : December 23, 2030

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Chloroquine or Hydroxychloroquine
Chloroquine or Hydroxychloroquine with standard of care treatment.
 Drug: Chloroquine or Hydroxychloroquine
Chloroquine or Hydroxychloroquine
Other Name: alexoquine, chloroquine, Hydroquine
No Intervention: No intervention
standard of care treatment alone.


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with cure or death [ Time Frame: 1 month ]
    the number of patients with cure or death


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Covid 19 patients

Exclusion Criteria:

  • Allergy or contraindication to the drug
  • Pregnant or lactating
  • Patients with cardiac problems
Contacts and Locations
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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): NCT04353336


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

Locations
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Egypt
Tanta University, Assiut University Recruiting
Tanta, Egypt, 35111
Contact: Sherief Abd-Elsalam         
Principal Investigator: Sherief Abd-Elsalam, ass. prof         
Sponsors and Collaborators
Tanta University
Investigators
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Principal Investigator: sherief Abd-Elsalam, Ass. Prof. Tanta University - Faculty of Medicine
More Information
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Responsible Party: Sherief Abd-Elsalam, Ass. Prof. Tropical Medicine, Tanta University
ClinicalTrials.gov Identifier: NCT04353336    
Other Study ID Numbers: chloroquine covid
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 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
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Hydroxychloroquine
Chloroquine
Chloroquine diphosphate
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Amebicides
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics