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

P

Princess Nourah Bint Abdulrahman University

Status and phase

Withdrawn
Phase 2

Conditions

Corona Virus Infection
Covid 19 Positive

Treatments

Drug: Artemisinin / Artesunate
Other: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04387240
20-0192

Details and patient eligibility

About

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,

Full 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.

Sex

All

Ages

18 to 60 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

0 participants in 2 patient groups, including a placebo group

intervention group
Experimental group
Description:
this group will receive the Artemisinin / Artesunate 100mg once daily for 5 days
Treatment:
Drug: Artemisinin / Artesunate
placibo
Placebo Comparator group
Description:
this group will receive a placebo of the same shape and picture of the study drug
Treatment:
Other: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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