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

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,

Study Overview

• Status: Withdrawn
• Conditions: Corona Virus Infection; Covid 19 Positive
• Intervention / Treatment: Drug: Artemisinin / Artesunate; Other: placebo

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 Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Saudi Arabia
  • Central
    • Riyadh, Central, Saudi Arabia, 11552
      • Princess Nourah Bint Abdulrahman Univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of stay in hospital	absence of the virus shedding evidenced by negative swabs	within the first 6 days intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of ICU admission	reduction of morbidity and mortality	14 days
resolution of symptoms	finding the time that the symptoms disappear	6 days - 10 day

Collaborators and Investigators

• Sponsor: Princess Nourah Bint Abdulrahman University
• Investigators: Principal Investigator: Osama Kentab, MD, Princess Nourah bint Abdulrahman University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Artesunate; artemisinin
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Anthelmintics; Schistosomicides; Antiplatyhelmintic Agents; Artesunate; Artemisinins; Artemisinin
• Other Study ID Numbers: 20-0192

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No