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

NCT04387240 | Withdrawn Phase 2 DMC

• 1 other identifier: 20-0192
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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,

Conditions

Covid 19 Positive; Corona Virus Infection

Keywords

artemisinin; Artesunate

Outcome Measures

Primary Outcomes (1)

• length of stay in hospital

  absence of the virus shedding evidenced by negative swabs

  within the first 6 days intervention

Secondary Outcomes (2)

• number of ICU admission

  14 days

• resolution of symptoms

  6 days - 10 day

Study Arms (2)

intervention group

EXPERIMENTAL

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

Drug: Artemisinin / Artesunate

placibo

PLACEBO COMPARATOR

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

Other: placebo

Interventions

Artemisinin / Artesunate DRUG

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

intervention group

placebo OTHER

placebo or sham drug will be given to the second arm

placibo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• · 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

Sponsors & Collaborators

• Princess Nourah Bint Abdulrahman University: lead

Study Sites (1)

Princess Nourah Bint Abdulrahman Univeristy

Riyadh, Central, 11552, Saudi Arabia

Location

MeSH Terms

Conditions

Coronavirus Infections

Interventions

artemisinin; Artesunate

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Sesquiterpenes; Terpenes; Hydrocarbons

Study Officials

• Osama Kentab, MD

  Princess Nourah Bint Abdulrahman University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: the pharmacy will do the randomization of the labeled drug and placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor of Emergency Medicine

Model Details: double blind controlled trial

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 13, 2020
• Study Start: January 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)