Back to resultsEfficacay of Chloroquine or Hydroxychloroquine in COVID-19 Treatment
Primary Purpose
COVID-19, Coronavirus Infection
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Chloroquine or Hydroxychloroquine
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Covid 19 patients
Exclusion Criteria:
- Allergy or contraindication to the drug
- Pregnant or lactating
- Patients with cardiac problems
Sites / Locations
- Tanta University, Assiut University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Chloroquine or Hydroxychloroquine
No intervention
Arm Description
Chloroquine or Hydroxychloroquine with standard of care treatment.
standard of care treatment alone.
Outcomes
Primary Outcome Measures
Number of patients with cure or death
the number of patients with cure or death
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04353336
Brief Title
Efficacay of Chloroquine or Hydroxychloroquine in COVID-19 Treatment
Official Title
Clinical Study Evaluating the Efficacy of Chloroquine or Hydroxychloroquine in COVID-19 Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 23, 2020 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Chloroquine or hydroxychloroquine in COVID-19 treatment
Detailed Description
Clinical Study Evaluating the Efficacy of Chloroquine or hydroxychloroquine in COVID-19 treatment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Coronavirus Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
194 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chloroquine or Hydroxychloroquine
Arm Type
Experimental
Arm Description
Chloroquine or Hydroxychloroquine with standard of care treatment.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
standard of care treatment alone.
Intervention Type
Drug
Intervention Name(s)
Chloroquine or Hydroxychloroquine
Other Intervention Name(s)
alexoquine, chloroquine, Hydroquine
Intervention Description
Chloroquine or Hydroxychloroquine
Primary Outcome Measure Information:
Title
Number of patients with cure or death
Description
the number of patients with cure or death
Time Frame
1 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Covid 19 patients
Exclusion Criteria:
Allergy or contraindication to the drug
Pregnant or lactating
Patients with cardiac problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sherief Abd-Elsalam, Ass. Prof.
Organizational Affiliation
Tanta University - Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanta University, Assiut University
City
Tanta
ZIP/Postal Code
35111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacay of Chloroquine or Hydroxychloroquine in COVID-19 Treatment
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