COVID-19Phase 2NCT04394442
Hydroxychloroquine in COVID-19 Patients
A Phase 2 study testing Hydroxychloroquine in people with COVID-19, run by Samah Lutfy at 1 site in Saudi Arabia.
Trial summary
Many reports argued about the possible beneficial effects of Hydroxychloroquine in treating COVID-19 patients and this study was designed to investigate this claim Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Hydroxychloroquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 21 Mar 2020to Aug 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed cases of SARS-CoV-2 by PCR
Who cannot join
- less than 18 years old known hypersensitivity to the drug
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
SNH
Mecca
Samah Lutfy, MD, +966581244415, omar1star2008@yahoo.com
About this study
Official title: Use of Hydroxychloroquine in Patients With COVID-19: A Randomized Controlled Clinical Trial
Many reports argued about the possible beneficial effects of Hydroxychloroquine in treating COVID-19 patients and this study was designed to investigate this claim
- Conditions
- COVID-19
- Being tested
- Hydroxychloroquine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
400mg BD first day then 200 mg BD for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Hydroxycholoroquine group | Experimental | Not described Receives: Drug: Hydroxychloroquine |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to viral clearance
PCR will be done every 72 h day till 2 consecutive negative PCR tests(24h apart) which is the viral clearance.The time between randomization and viral clearance is the viral clearance time
Measured: 21 days after patients randomization
% of mortality
total number of deaths divided by total number of the group
Measured: 60 days after randomization
Secondary outcomes (3)
Length of stay
time from patients randomization till discharge
Measured: 60 days after randomization
time to be afebrile
time from randomization till day of fever subsiding
Measured: 60 days after randomization
need for mechanical ventilation
%of deteriorated patients necessitates mechanical ventilation
Measured: 60 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start21 Mar 2020
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samah Lutfy
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Samah Lutfy, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394442
- Sponsor's protocol ID
- SNH1352020
- Status last verified
- May 2020
- First submitted
- 17 May 2020
- Last updated
- 19 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Hydroxychloroquine in Patients With COVID-19: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04394442
- Acronym / sponsor ID
- SNH1352020
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Samah LutfyOther government
- Study start
- 21 Mar 2020 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 19 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.
Many reports argued about the possible beneficial effects of Hydroxychloroquine in treating COVID-19 patients and this study was designed to investigate this claim
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydroxycholoroquine group | Experimental | Drug: Hydroxychloroquine |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Confirmed cases of SARS-CoV-2 by PCR
Key exclusion criteria (1 listed)
- less than 18 years old known hypersensitivity to the drug
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 |
|---|---|---|
| Hydroxychloroquine400mg BD first day then 200 mg BD for 5 days | Drug | Hydroxycholoroquine group |
Primary outcome
time to viral clearance
Time frame: 21 days after patients randomization
PCR will be done every 72 h day till 2 consecutive negative PCR tests(24h apart) which is the viral clearance.The time between randomization and viral clearance is the viral clearance time
% of mortality
Time frame: 60 days after randomization
total number of deaths divided by total number of the group
3 secondary outcomes
Length of stay
Time frame: 60 days after randomization
time to be afebrile
Time frame: 60 days after randomization
need for mechanical ventilation
Time frame: 60 days after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
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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.
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 Hydroxychloroquine in people with COVID-19, run by Samah Lutfy 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 May 2020. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samah M Lutfy, MD (+966581244415, omar1star2008@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to viral clearance (time frame: 21 days after patients randomization). The study lists 2 primary outcomes in all. 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 19 May 2020.