Corona Virus Infection, Covid 19 Positive
Conditions
Keywords
artemisinin, Artesunate
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.
Interventions
DRUGArtemisinin / Artesunate
testing the drug capabilities in reducing the shedding and causing the testing for covid 19 to become negative
OTHERplacebo
placebo or sham drug will be given to the second arm
Sponsors
Princess Nourah Bint Abdulrahman University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
the pharmacy will do the randomization of the labeled drug and placebo
Intervention model description
double blind controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| length of stay in hospital | within the first 6 days intervention | absence of the virus shedding evidenced by negative swabs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Saudi Arabia
Outcome results
None listed