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

Corona Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04387240
• Other study ID #: 20-0192
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2022
• Est. completion date: December 2022

Study information

• Verified date: April 2022
• Source: Princess Nourah Bint Abdulrahman University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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,

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• Covid 19 Positive
• COVID-19

Intervention

Drug:
• Artemisinin / Artesunate
testing the drug capabilities in reducing the shedding and causing the testing for covid 19 to become negative

Other:
• placebo
placebo or sham drug will be given to the second arm

Locations

Country	Name	City	State
Saudi Arabia	Princess Nourah Bint Abdulrahman Univeristy	Riyadh	Central

Sponsors (1)

Lead Sponsor	Collaborator
Princess Nourah Bint Abdulrahman University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of stay in hospital	absence of the virus shedding evidenced by negative swabs	within the first 6 days intervention
Secondary	number of ICU admission	reduction of morbidity and mortality	14 days
Secondary	resolution of symptoms	finding the time that the symptoms disappear	6 days - 10 day