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

Sponsor

Princess Nourah Bint Abdulrahman University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04387240

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Covid 19 Positive Corona Virus Infection	Drug: Artemisinin / Artesunate Other: placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

double blind controlled trialdouble blind controlled trial

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

the pharmacy will do the randomization of the labeled drug and placebo

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: intervention group

this group will receive the Artemisinin / Artesunate 100mg once daily for 5 days

Drug: Artemisinin / Artesunate

testing the drug capabilities in reducing the shedding and causing the testing for covid 19 to become negative

Placebo Comparator: placibo

this group will receive a placebo of the same shape and picture of the study drug

Other: placebo

placebo or sham drug will be given to the second arm

Outcome Measures

Primary Outcome Measures

length of stay in hospital [within the first 6 days intervention]
absence of the virus shedding evidenced by negative swabs

Secondary Outcome Measures

number of ICU admission [14 days]
reduction of morbidity and mortality
resolution of symptoms [6 days - 10 day]
finding the time that the symptoms disappear

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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