Evaluating the Efficacy of Artesunate in Adults With Mild... | NCT04387240

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

NCT04387240

Sponsor

Princess Nourah Bint Abdulrahman University

Status

Withdrawn

Last Update Posted

May 2, 2022Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Covid 19 Positive
Corona Virus Infection

Interventions

Artemisinin / Artesunate
placebo

Countries

Saudi Arabia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

did not get enough fund and IRB request

Expanded Access Info

Start Date

Jan 2022Estimated

Primary Completion Date

Sep 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

May 12, 2020

First Submission Date that Met QC Criteria

May 12, 2020

First Posted Date

May 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2022

Last Update Posted Date

May 2, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

osama y kentab, Clinical Associate Professor of Emergency Medicine, Princess Nourah Bint Abdulrahman UniversityPrincipal Investigator

Lead Sponsor

Princess Nourah Bint Abdulrahman UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Artemisinin / Artesunate	Drug	testing the drug capabilities in reducing the shedding and causing the testing for covid 19 to become negative	intervention group

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Osama Kentab, MD	Princess Nourah Bint Abdulrahman University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Princess Nourah Bint Abdulrahman Univeristy		Riyadh	Central	11552	Saudi Arabia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018352	Coronavirus Infections

Ancestor Terms

ID	Term
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C031327	artemisinin
D000077332	Artesunate

Ancestor Terms

ID	Term
D037621	Artemisinins
D017382	Reactive Oxygen Species
D005609	Free Radicals
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided