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

NCT ID: NCT04387240

Last Updated: 2022-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-31

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Covid 19 Positive Corona Virus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double blind controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
the pharmacy will do the randomization of the labeled drug and placebo

Study Groups

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intervention group

this group will receive the Artemisinin / Artesunate 100mg once daily for 5 days

Group Type EXPERIMENTAL

Artemisinin / Artesunate

Intervention Type DRUG

testing the drug capabilities in reducing the shedding and causing the testing for covid 19 to become negative

placibo

this group will receive a placebo of the same shape and picture of the study drug

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo or sham drug will be given to the second arm

Interventions

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Artemisinin / Artesunate

testing the drug capabilities in reducing the shedding and causing the testing for covid 19 to become negative

Intervention Type DRUG

placebo

placebo or sham drug will be given to the second arm

Intervention Type OTHER

Eligibility Criteria

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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

* ยท 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Princess Nourah Bint Abdulrahman University

OTHER

Sponsor Role lead

Responsible Party

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osama y kentab

Clinical Associate Professor of Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Osama Kentab, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Nourah Bint Abdulrahman University

Locations

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Princess Nourah Bint Abdulrahman Univeristy

Riyadh, Central, Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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20-0192

Identifier Type: -

Identifier Source: org_study_id

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