Covid 19 PositivePhase 2NCT04387240
Evaluating the Efficacy of Artesunate in Adults With Mild Symptoms of COVID-19
A Phase 2 study testing Artemisinin / Artesunate in people with Covid 19 Positive and Corona Virus Infection, run by Princess Nourah Bint Abdulrahman University at 1 site in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Covid 19 Positive, Corona Virus Infection
- What is being tested?
- Artemisinin / Artesunate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jan 2022to Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- · 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
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Princess Nourah Bint Abdulrahman Univeristy
Riyadh, Central, 11552
About this study
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,
Read the 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.
- Conditions
- Covid 19 Positive, Corona Virus Infection
- Being tested
- Artemisinin / Artesunate, placebo
- Keywords
- artemisinin, Artesunate
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemisinin / ArtesunateDrug
testing the drug capabilities in reducing the shedding and causing the testing for covid 19 to become negative
placeboOther
placebo or sham drug will be given to the second arm
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | this group will receive the Artemisinin / Artesunate 100mg once daily for 5 days Receives: Drug: Artemisinin / Artesunate |
| placibo | Placebo comparator | this group will receive a placebo of the same shape and picture of the study drug Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of stay in hospital
absence of the virus shedding evidenced by negative swabs
Measured: within the first 6 days intervention
Secondary outcomes (2)
number of ICU admission
reduction of morbidity and mortality
Measured: 14 days
resolution of symptoms
finding the time that the symptoms disappear
Measured: 6 days - 10 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study startJan 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: did not get enough fund and IRB request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid 19 PositiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blind controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Princess Nourah Bint Abdulrahman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, osama y kentab, Princess Nourah Bint Abdulrahman University
- Investigators
- Osama Kentab, MD, Principal investigator, Princess Nourah Bint Abdulrahman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387240
- Sponsor's protocol ID
- 20-0192
- Status last verified
- Apr 2022
- First submitted
- 12 May 2020
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Artesunate in Adults With Mild Symptoms of COVID-19
- ClinicalTrials.gov ID
- NCT04387240
- Acronym / sponsor ID
- 20-0192
- Conditions
- Covid 19 Positive, Corona Virus Infection
- Keywords
- artemisinin, Artesunate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: did not get enough fund and IRB request
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Princess Nourah Bint Abdulrahman UniversityUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- double blind controlled trial
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Drug: Artemisinin / Artesunatethis group will receive the Artemisinin / Artesunate 100mg once daily for 5 days |
| placibo | Placebo comparator | Other: placebothis group will receive a placebo of the same shape and picture of the study drug |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- · Patients who have sever disease- shortness of breath, sick patients or admitted in ICU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artemisinin / Artesunatetesting the drug capabilities in reducing the shedding and causing the testing for covid 19 to become negative | Drug | intervention group |
| placeboplacebo or sham drug will be given to the second arm | Other | placibo |
Primary outcome
length of stay in hospital
Time frame: within the first 6 days intervention
absence of the virus shedding evidenced by negative swabs
2 secondary outcomes
number of ICU admission
Time frame: 14 days
resolution of symptoms
Time frame: 6 days - 10 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osama Kentab, MD principal investigator
Princess Nourah Bint Abdulrahman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Artemisinin / Artesunate in people with Covid 19 Positive and Corona Virus Infection, run by Princess Nourah Bint Abdulrahman University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of stay in hospital (time frame: within the first 6 days intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.