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

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ClinicalTrials.gov Identifier: NCT04387240
Recruitment Status : Not yet recruiting
First Posted : May 13, 2020
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
osama y kentab, 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,


Condition or disease Intervention/treatment Phase
Covid 19 Positive Corona Virus Infection Drug: Artemisinin / Artesunate Other: placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double blind controlled trial
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: the pharmacy will do the randomization of the labeled drug and placebo
Primary Purpose: Treatment
Official Title: Evaluating the Efficacy of Artesunate in Adults With Mild Symptoms of COVID-19
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intervention group
this group will receive the Artemisinin / Artesunate 100mg once daily for 5 days
Drug: Artemisinin / Artesunate
testing the drug capabilities in reducing the shedding and causing the testing for covid 19 to become negative

Placebo Comparator: placibo
this group will receive a placebo of the same shape and picture of the study drug
Other: placebo
placebo or sham drug will be given to the second arm




Primary Outcome Measures :
  1. length of stay in hospital [ Time Frame: within the first 6 days intervention ]
    absence of the virus shedding evidenced by negative swabs


Secondary Outcome Measures :
  1. number of ICU admission [ Time Frame: 14 days ]
    reduction of morbidity and mortality

  2. resolution of symptoms [ Time Frame: 6 days - 10 day ]
    finding the time that the symptoms disappear



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04387240


Contacts
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Contact: Osama Y Kentab, MD +966504237900 oykentab@kaauh.edu.sa
Contact: Abdulaziz S Algarni, MD +966501239461 absalgarni@kaauh.edu.sa

Locations
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Saudi Arabia
Princess Nourah Bint Abdulrahman Univeristy
Riyadh, Central, Saudi Arabia, 11552
Sponsors and Collaborators
Princess Nourah Bint Abdulrahman University
Investigators
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Principal Investigator: Osama Kentab, MD Princess Nourah Bint Abdulrahman University
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Responsible Party: osama y kentab, Clinical Associate Professor of Emergency Medicine, Princess Nourah Bint Abdulrahman University
ClinicalTrials.gov Identifier: NCT04387240    
Other Study ID Numbers: 20-0192
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by osama y kentab, Princess Nourah Bint Abdulrahman University:
artemisinin
Artesunate
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Artesunate
Artemisinins
Artemisinine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics