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

Phase 2

Withdrawn

• Conditions: Corona Virus Infection; Covid 19 Positive
• Interventions: Drug: Artemisinin / Artesunate; Other: placebo

• Registration Number: NCT04387240
• Lead Sponsor: Princess Nourah Bint Abdulrahman University

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.

Study Timeline

• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-12
• Study First Posted: 2020-05-13
• Study Start: 2022-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-05-02
• Primary Completion: 2022-09
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	Artemisinin / Artesunate	this group will receive the Artemisinin / Artesunate 100mg once daily for 5 days
placibo	placebo	this group will receive a placebo of the same shape and picture of the study drug

Primary Outcome Measures

Name	Time	Method
length of stay in hospital	within the first 6 days intervention	absence of the virus shedding evidenced by negative swabs

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Princess Nourah Bint Abdulrahman Univeristy; 🇸🇦 Riyadh, Central, Saudi Arabia