Clinical trial NCT04387240: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Covid 19 Positive
Corona Virus Infection
Keywords: artemisinin
Artesunate
Lead sponsor: Princess Nourah Bint Abdulrahman University
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: length of stay in hospital
timeFrame: within the first 6 days intervention
Secondary outcomes:
measure: number of ICU admission
timeFrame: 14 days
measure: resolution of symptoms
timeFrame: 6 days - 10 day
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Princess Nourah Bint Abdulrahman Univeristy
state: Central
Study officials:
affiliation: Princess Nourah Bint Abdulrahman University
name: Osama Kentab, MD
role: PRINCIPAL_INVESTIGATOR
References: