Evaluating the Efficacy of Artesunate in Adults With Mild Symptoms of COVID-19
Primary Purpose
Covid 19 Positive, Corona Virus Infection
Status
Withdrawn
Phase
Phase 2
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Artemisinin / Artesunate
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid 19 Positive focused on measuring artemisinin, Artesunate
Eligibility Criteria
Inclusion Criteria:
- Adult patient age more than 18 and less than 60 years
- Symptomatic , positive swab covid-19 patients
- Patients who have mild to moderate symptoms
- Patients who have no risk factors like
- Patients who is not on other medications rather those on supportive care
Exclusion Criteria:
· Patients who have sever disease- shortness of breath, sick patients or admitted in ICU
- Patients who are receiving ventilation supports
- High risk group like :- age more than 60 years, chronic heart diseases, chronic lungs diseases, diabetes, immunocompromised diseases or on immune suppression medications or pregnant women
- Patients who are on other medications which used as treatment for covid 19
Sites / Locations
- Princess Nourah Bint Abdulrahman Univeristy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
intervention group
placibo
Arm Description
this group will receive the Artemisinin / Artesunate 100mg once daily for 5 days
this group will receive a placebo of the same shape and picture of the study drug
Outcomes
Primary Outcome Measures
length of stay in hospital
absence of the virus shedding evidenced by negative swabs
Secondary Outcome Measures
number of ICU admission
reduction of morbidity and mortality
resolution of symptoms
finding the time that the symptoms disappear
Full Information
NCT ID
NCT04387240
First Posted
May 12, 2020
Last Updated
April 26, 2022
Sponsor
Princess Nourah Bint Abdulrahman University
1. Study Identification
Unique Protocol Identification Number
NCT04387240
Brief Title
Evaluating the Efficacy of Artesunate in Adults With Mild Symptoms of COVID-19
Official Title
Evaluating the Efficacy of Artesunate in Adults With Mild Symptoms of COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
did not get enough fund and IRB request
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Princess Nourah Bint Abdulrahman University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus.
At this time, there are no specific vaccines or treatments for COVID-19. However, there are many ongoing clinical trials evaluating potential treatments Drugs used to treat malaria infection has shown to be beneficial for many other diseases, including viral infections.
In this Clinical trial, Investigators will evaluate the effect of Artemisinin / Artesunate on morbidity of COVID-19 patients in decreasing the course of the disease and viral load in symptomatic stable positive swab COVID-19 patients. Investigators are hypothesizing that due to the antiviral properties of this drug it will help as a treatment for the COVID -19 patients. In improving their condition and clearing the virus load,
Detailed Description
In this Clinical trial, Investigators will evaluate the effect of Artemisinin / Artesunate on morbidity of COVID-19 patients in decreasing the course of the disease and viral load in symptomatic stable positive swab COVID-19 patients. investigators are hypothesizing that due to the antiviral properties of this drug it will help as a treatment for the COVID -19 patients. In improving their condition and clearing the virus load, investigators are testing two groups the one that will take the drug and then compare them to a placebo group that will not take any drug for the treatment in a blinded fashion made by randomization done by our pharmacy team so investigators eliminate risk of bias. Our expectation is to find a total reduction of the hospital stay to 7 days instead of 14 days currently indicating the effectiveness of the medication in eradicating the virus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid 19 Positive, Corona Virus Infection
Keywords
artemisinin, Artesunate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
double blind controlled trial
Masking
ParticipantCare ProviderInvestigator
Masking Description
the pharmacy will do the randomization of the labeled drug and placebo
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
this group will receive the Artemisinin / Artesunate 100mg once daily for 5 days
Arm Title
placibo
Arm Type
Placebo Comparator
Arm Description
this group will receive a placebo of the same shape and picture of the study drug
Intervention Type
Drug
Intervention Name(s)
Artemisinin / Artesunate
Intervention Description
testing the drug capabilities in reducing the shedding and causing the testing for covid 19 to become negative
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo or sham drug will be given to the second arm
Primary Outcome Measure Information:
Title
length of stay in hospital
Description
absence of the virus shedding evidenced by negative swabs
Time Frame
within the first 6 days intervention
Secondary Outcome Measure Information:
Title
number of ICU admission
Description
reduction of morbidity and mortality
Time Frame
14 days
Title
resolution of symptoms
Description
finding the time that the symptoms disappear
Time Frame
6 days - 10 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patient age more than 18 and less than 60 years
Symptomatic , positive swab covid-19 patients
Patients who have mild to moderate symptoms
Patients who have no risk factors like
Patients who is not on other medications rather those on supportive care
Exclusion Criteria:
· Patients who have sever disease- shortness of breath, sick patients or admitted in ICU
Patients who are receiving ventilation supports
High risk group like :- age more than 60 years, chronic heart diseases, chronic lungs diseases, diabetes, immunocompromised diseases or on immune suppression medications or pregnant women
Patients who are on other medications which used as treatment for covid 19
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osama Kentab, MD
Organizational Affiliation
Princess Nourah Bint Abdulrahman University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Nourah Bint Abdulrahman Univeristy
City
Riyadh
State/Province
Central
ZIP/Postal Code
11552
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluating the Efficacy of Artesunate in Adults With Mild Symptoms of COVID-19
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