Evaluating the Efficacy of Artesunate in Adults With Mild Symptoms of COVID-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluating the Efficacy of Artesunate in Adults With Mild Symptoms of COVID-19

Conditions
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Covid 19 Positive, Corona Virus Infection

Intervention / Treatment
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* Drug: Artemisinin / Artesunate
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double blind controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>this group will receive the Artemisinin / Artesunate 100mg once daily for 5 days | Drug: Artemisinin / Artesunate<br>* testing the drug capabilities in reducing the shedding and causing the testing for covid 19 to become negative<br>|
| Placebo Comparator: placibo<br>this group will receive a placebo of the same shape and picture of the study drug | Other: placebo<br>* placebo or sham drug will be given to the second arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of stay in hospital | absence of the virus shedding evidenced by negative swabs | within the first 6 days intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of ICU admission | reduction of morbidity and mortality | 14 days | 
| resolution of symptoms | finding the time that the symptoms disappear | 6 days - 10 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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artemisinin, Artesunate