Pneumonia, ViralPhase 2/3NCT04347031

A Study of the Effectiveness of an Off Label Mefloquine Use for the Treatment of Patients With COVID19

A Phase 2/3 study testing Mefloquine, Hydroxychloroquine and Mefloquine + azithromycin + / - tocilizumab in people with Pneumonia, Viral and Respiratory Failure, run by Burnasyan Federal Medical Biophysical Center at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Study of the effectiveness and safety of the drug Mefloquine, tablets 250 mg, produced by FSUE "SPC" Farmzaschita " FMBA of Russia (Russia), in comparison with the drug Hydroxychloroquine, tablets 200 mg, for the treatment of patients with coronavirus infection, in the "off-label" mode, to make a decision on the… Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Pneumonia, Viral, Respiratory Failure
What is being tested?: Mefloquine, Hydroxychloroquine and Mefloquine + azithromycin + / - tocilizumab
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 320 participants
Where: 1 siteRussia
Study dates: 8 Apr 2020to 20 Nov 2020
Phase: Phase 2/3
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

Male and female patients aged 18 years and older COVID19 positive confirmed by PCR, without ARDS and sepsis.
Hospitalization of the patient.
Signed informed consent for participation in the study.

Who cannot join

The criteria for retiring a volunteer during the screening period are:
Revoking informed consent of patients.
Non-compliance of the volunteer with the inclusion criteria.
First identified the condition and/or disease described in the criteria for inclusion.
Positive test for HIV infection, Hepatitis B, C, syphilis.
The criteria for early termination of participation of volunteers in the study during the period of use of the study drug are:

Show all 15Show fewer

Withdrawal of informed consent by a volunteer.
First identified the condition and/or disease described in the criteria for inclusion.
Occurrence of serious adverse events.
Adverse events that do not meet the criteria of severity, in the development of which, in the opinion of the researcher, further participation in the study may be harmful to the health or well-being of the volunteer.
The need for patients included in the study, antibiotics of the fluoroquinolone group.
Administrative reasons (termination of the study by the Sponsor or regulatory authorities), as well as gross violations of the Protocol that may affect the results of the study.
the Patient receives / needs additional treatment that may affect the outcome of the study or the patient's safety
Individual intolerance to research drugs
Erroneous inclusion (for example, the patient was included in violation of the criteria for inclusion/non-inclusion of the Protocol).

Trial locations and contacts

1 site in 1 country.

Russia1 site

Burnasyan Federal Medical Biophysical Center FMBA of Russia
Moscow, 123098

Other trials in Russia

About this study

Official title: An Open Randomized Study of the Effectiveness of the Drug Mefloquine, Tablets 250 mg, Produced by FSUE SPC "Farmzashita" of the Federal Medical Biological Agency, FMBA of Russia (Russia) for the Treatment of Patients With COVID19

Read the detailed description

Purpose of the study:

Study of the effectiveness and safety of the drug Mefloquine, tablets 250 mg, produced by FSUE "SPC" farmzaschita " FMBA of Russia (Russia), in comparison with the drug Hydroxychloroquine, tablets 200 mg, for the treatment of patients with coronavirus infection, in the "off-label" mode, to make a decision on the possibility of expanding the indications for use.

Study aims:

To study the efficacy of the drug Mefloquine, tablet 250 mg, for the treatment of patients with coronavirus infection (light and medium-heavy form), the appointment in the "off-label" in comparison with the drug Hydroxychloroquine tablets 200 mg, when administered in the mode "off label".
To study the effectiveness of the drug Mefloquine, tablet 250 mg, when administered in the mode "off label", in comparison with the drug Hydroxychloroquine tablets 200 mg, when administered in the mode "off label" when applied to a schema for the treatment of patients with severe coronavirus infection.
Evaluate the safety and tolerability of Mefloquine, 250 mg tablets, and Hydroxychloroquine, 200 mg tablets, for the treatment of patients with coronavirus infection (mild and moderate-severe forms).
Evaluate the safety and tolerability of Mefloquine, 250 mg tablets, and Hydroxychloroquine, 200 mg tablets, for the treatment of patients with coronavirus infection (severe forms), when used as part of a regimen for the treatment of patients with severe coronavirus infection.

Study design:

An open, randomized, multicenter comparative study of the efficacy and safety of Mefloquine and Hydroxychloroquine in "off-label" mode for the treatment of patients with COVID-19 coronavirus infection

Conditions: Pneumonia, Viral, Respiratory Failure
Being tested: Mefloquine, Hydroxychloroquine, Mefloquine + azithromycin + / - tocilizumab, Hydroxychloroquine + azithromycin + / - tocilizumab
Medical subject headings: Pneumonia, Viral, Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MefloquineDrug
1st day: 750 mg of mefloquine per day, inside, in tablets of 250 mg 3 times a day - 1 tablet every 8 hours.
- Day 2: 500 mg of mefloquine, inside, in tablets of 250 mg 2 times a day - 1 tablet every 12 hours.
- 3rd - 7th day: 250 mg of mefloquine, inside, in tablets of 250 mg 1 time a day at the same time.
HydroxychloroquineDrug
1. st day: 800 mg of hydroxychloroquine per day, inside, in 200 mg tablets, 2 tablets 2 times a day;
2. nd - 7th day: 400 mg of hydroxychloroquine per day, inside, in tablets of 200 mg, 1 tablet 2 times a day.
Mefloquine + azithromycin + / - tocilizumabCombination product
1st day: 750 mg of mefloquine per day, inside, in tablets of 250 mg 3 times a day - 1 tablet every 8 hours.
- Day 2: 500 mg of mefloquine, inside, in tablets of 250 mg 2 times a day - 1 tablet every 12 hours.
- 3rd - 7th day: 250 mg of mefloquine, inside, in tablets of 250 mg 1 time a day at the same time.
Hydroxychloroquine + azithromycin + / - tocilizumabCombination product
1. st day: 800 mg of hydroxychloroquine per day, inside, in 200 mg tablets, 2 tablets 2 times a day;
2. nd - 7th day: 400 mg of hydroxychloroquine per day, inside, in tablets of 200 mg, 1 tablet 2 times a day.

Study groups in NCT04347031
Study group	Role	What they receive
group 1 cohort 1	Experimental	80 patients who receive Mefloquine prescribed according to the following scheme: * 1st day: 750 mg of mefloquine per day, inside, in tablets of 250 mg 3 times a day - 1 tablet every 8 hours. * Day 2: 500 mg of mefloquine, inside, in tablets of 250 mg 2 times a day - 1 tablet every 12 hours. * 3rd - 7th day: 250 mg of mefloquine, inside, in tablets of 250 mg 1 time a day at the same time. Receives: Drug: Mefloquine
group 1 cohort 2	Experimental	80 patients who receive Hydroxychloroquine prescribed according to the following scheme: • 1st day: 800 mg of hydroxychloroquine per day, inside, in 200 mg tablets, 2 tablets 2 times a day; 2nd - 7th day: 400 mg of hydroxychloroquine per day, inside, in tablets of 200 mg, 1 tablet 2 times a day. Receives: Drug: Hydroxychloroquine
group 2 cohort 1	Experimental	A concomitant therapy consisting of Mefloquine in conjunction with azithromycin and tocilizumab will be given for 80 patients. Dosage of Mefloquine is same as for group 1 cohort 1. Receives: Combination Product: Mefloquine + azithromycin + / - tocilizumab
group 2 cohort 2	Experimental	A concomitant therapy consisting of Hydroxychloroquine in conjunction with azithromycin and tocilizumab will be given for 80 patients. Dosage of Hydroxychloroquine is same as for group 1 cohort 2. Receives: Combination Product: Hydroxychloroquine + azithromycin + / - tocilizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

1st primary endpoint for group 1
The number of patients with development of respiratory failure requiring transfer to the ICU.
Measured: up to 10 days
2nd primary endpoint for group 1
The period of clinical recovery.
Measured: up to 10 days
1st primary endpoint for group 2
The period of clinical recovery.
Measured: up to 10 days
2nd primary endpoint for group 2
Frequency of fatal outcomes associated with coronavirus infection disease (COVID19)
Measured: through study completion, an average of 3 months

Secondary outcomes (12)

1st secondary endpoint for group 1
A change in viral load by conducting PCR assay through different timeframes
Measured: on days 5 and 10
2nd secondary endpoint for group 1
Frequency of clinical cure on day 10 from the start of therapy
Measured: on day 10
3d secondary endpoint for group 1
The retention time of the reaction temperature from the start of the treatment.
Measured: up to 10 days
4th secondary endpoint for group 1
Concentration of C-reactive protein in blood plasma.
Measured: up to 10 days
5th secondary endpoint for group 1
Respiratory index.
Measured: up to 10 days
6th secondary endpoint for group 1
Frequency appearance unwanted phenomena and serious unwanted phenomena
Measured: up to 10 days
1st secondary endpoint for group 2
A change in viral load by conducting PCR assay through different timeframes
Measured: on days 5 and 10
2nd secondary endpoint for group 2
Respiratory index.
Measured: up to 10 days
3d secondary endpoint for group 2
The retention time of the reaction temperature from the start of treatment.
Measured: up to 10 days
4th secondary endpoint for group 2
Concentration of C-reactive protein in blood plasma.
Measured: up to 10 days
5th secondary endpoint for group 2
Number of patients required transition to alternative therapy schedule
Measured: up to 10 days
6th secondary endpoint for group 2
Frequency of adverse events and serious adverse events
Measured: up to 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Apr 202020 Nov 2020

First posted15 Apr 2020
Study start8 Apr 2020
Primary completion1 Nov 2020
Study completion20 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pneumonia, ViralStudies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 320 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04347031
Sponsor's protocol ID: FL-01/20
Status last verified: Jan 2021
First submitted: 7 Apr 2020
Last updated: 27 Jan 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Randomized Study of the Effectiveness of the Drug Mefloquine, Tablets 250 mg, Produced by FSUE SPC "Farmzashita" of the Federal Medical Biological Agency, FMBA of Russia (Russia) for the Treatment of Patients With COVID19
ClinicalTrials.gov ID: NCT04347031
Acronym / sponsor ID: FL-01/20
Conditions: Pneumonia, Viral, Respiratory Failure
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 320 participants (actual)
Lead sponsor: Burnasyan Federal Medical Biophysical CenterOther government
Study start: 8 Apr 2020 (actual)
Primary completion: 1 Nov 2020 (actual)
Study completion: 20 Nov 2020 (actual)
First posted: 15 Apr 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.

Detailed description

Purpose of the study:

Study aims:

To study the efficacy of the drug Mefloquine, tablet 250 mg, for the treatment of patients with coronavirus infection (light and medium-heavy form), the appointment in the "off-label" in comparison with the drug Hydroxychloroquine tablets 200 mg, when administered in the mode "off label".
To study the effectiveness of the drug Mefloquine, tablet 250 mg, when administered in the mode "off label", in comparison with the drug Hydroxychloroquine tablets 200 mg, when administered in the mode "off label" when applied to a schema for the treatment of patients with severe coronavirus infection.
Evaluate the safety and tolerability of Mefloquine, 250 mg tablets, and Hydroxychloroquine, 200 mg tablets, for the treatment of patients with coronavirus infection (mild and moderate-severe forms).
Evaluate the safety and tolerability of Mefloquine, 250 mg tablets, and Hydroxychloroquine, 200 mg tablets, for the treatment of patients with coronavirus infection (severe forms), when used as part of a regimen for the treatment of patients with severe coronavirus infection.

Study design:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
group 1 cohort 1	Experimental	Drug: Mefloquine80 patients who receive Mefloquine prescribed according to the following scheme: * 1st day: 750 mg of mefloquine per day, inside, in tablets of 250 mg 3 times a day - 1 tablet every 8 hours. * Day 2: 500 mg of mefloquine, inside, in tablets of 250 mg 2 times a day - 1 tablet every 12 hours. * 3rd - 7th day: 250 mg of mefloquine, inside, in tablets of 250 mg 1 time a day at the same time.
group 1 cohort 2	Experimental	Drug: Hydroxychloroquine80 patients who receive Hydroxychloroquine prescribed according to the following scheme: • 1st day: 800 mg of hydroxychloroquine per day, inside, in 200 mg tablets, 2 tablets 2 times a day; 2nd - 7th day: 400 mg of hydroxychloroquine per day, inside, in tablets of 200 mg, 1 tablet 2 times a day.
group 2 cohort 1	Experimental	Combination Product: Mefloquine + azithromycin + / - tocilizumabA concomitant therapy consisting of Mefloquine in conjunction with azithromycin and tocilizumab will be given for 80 patients. Dosage of Mefloquine is same as for group 1 cohort 1.
group 2 cohort 2	Experimental	Combination Product: Hydroxychloroquine + azithromycin + / - tocilizumabA concomitant therapy consisting of Hydroxychloroquine in conjunction with azithromycin and tocilizumab will be given for 80 patients. Dosage of Hydroxychloroquine is same as for group 1 cohort 2.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Male and female patients aged 18 years and older COVID19 positive confirmed by PCR, without ARDS and sepsis.
Hospitalization of the patient.
Signed informed consent for participation in the study.

Key exclusion criteria (15 listed)

The criteria for retiring a volunteer during the screening period are:
The criteria for early termination of participation of volunteers in the study during the period of use of the study drug are:
Withdrawal of informed consent by a volunteer.
First identified the condition and/or disease described in the criteria for inclusion.
Occurrence of serious adverse events.

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
Mefloquine1st day: 750 mg of mefloquine per day, inside, in tablets of 250 mg 3 times a day - 1 tablet every 8 hours. * Day 2: 500 mg of mefloquine, inside, in tablets of 250 mg 2 times a day - 1 tablet every 12 hours. * 3rd - 7th day: 250 mg of mefloquine, inside, in tablets of 250 mg 1 time a day at the same time.	Drug	group 1 cohort 1
Hydroxychloroquine1. st day: 800 mg of hydroxychloroquine per day, inside, in 200 mg tablets, 2 tablets 2 times a day; 2. nd - 7th day: 400 mg of hydroxychloroquine per day, inside, in tablets of 200 mg, 1 tablet 2 times a day.	Drug	group 1 cohort 2
Mefloquine + azithromycin + / - tocilizumab1st day: 750 mg of mefloquine per day, inside, in tablets of 250 mg 3 times a day - 1 tablet every 8 hours. * Day 2: 500 mg of mefloquine, inside, in tablets of 250 mg 2 times a day - 1 tablet every 12 hours. * 3rd - 7th day: 250 mg of mefloquine, inside, in tablets of 250 mg 1 time a day at the same time.	Combination product	group 2 cohort 1
Hydroxychloroquine + azithromycin + / - tocilizumab1. st day: 800 mg of hydroxychloroquine per day, inside, in 200 mg tablets, 2 tablets 2 times a day; 2. nd - 7th day: 400 mg of hydroxychloroquine per day, inside, in tablets of 200 mg, 1 tablet 2 times a day.	Combination product	group 2 cohort 2

Primary outcome

1st primary endpoint for group 1
Time frame: up to 10 days
The number of patients with development of respiratory failure requiring transfer to the ICU.
2nd primary endpoint for group 1
Time frame: up to 10 days
The period of clinical recovery.
1st primary endpoint for group 2
Time frame: up to 10 days
The period of clinical recovery.
2nd primary endpoint for group 2
Time frame: through study completion, an average of 3 months
Frequency of fatal outcomes associated with coronavirus infection disease (COVID19)

12 secondary outcomes

1st secondary endpoint for group 1
Time frame: on days 5 and 10
2nd secondary endpoint for group 1
Time frame: on day 10
3d secondary endpoint for group 1
Time frame: up to 10 days
4th secondary endpoint for group 1
Time frame: up to 10 days
5th secondary endpoint for group 1
Time frame: up to 10 days
6th secondary endpoint for group 1
Time frame: up to 10 days
1st secondary endpoint for group 2
Time frame: on days 5 and 10
2nd secondary endpoint for group 2
Time frame: up to 10 days
3d secondary endpoint for group 2
Time frame: up to 10 days
4th secondary endpoint for group 2
Time frame: up to 10 days
5th secondary endpoint for group 2
Time frame: up to 10 days
6th secondary endpoint for group 2
Time frame: up to 10 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.

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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.

Tatiana Astrelina, MD PhD,DSc. principal investigator

Burnasyan FMBC SRC FMBA of Russia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 15 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: finished, as of the sponsor's last update on 27 Jan 2021. 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 Russia. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

1st primary endpoint for group 1 (time frame: up to 10 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04347031.

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 27 Jan 2021.