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

Respiratory Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04347031
• Other study ID #: FL-01/20
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 8, 2020
• Est. completion date: November 20, 2020

Study information

• Verified date: January 2021
• Source: Burnasyan Federal Medical Biophysical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 possibility of expanding the indications for use.

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:

1. 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".

2. 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.

3. 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).

4. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: November 20, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• The criteria for retiring a volunteer during the screening period are:

1. Revoking informed consent of patients.

2. Non-compliance of the volunteer with the inclusion criteria.

3. First identified the condition and/or disease described in the criteria for inclusion.

4. 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:

1. Withdrawal of informed consent by a volunteer.

2. First identified the condition and/or disease described in the criteria for inclusion.

3. Occurrence of serious adverse events.

4. 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.

5. The need for patients included in the study, antibiotics of the fluoroquinolone group.

6. 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.

7. the Patient receives / needs additional treatment that may affect the outcome of the study or the patient's safety

8. Individual intolerance to research drugs

9. Erroneous inclusion (for example, the patient was included in violation of the criteria for inclusion/non-inclusion of the Protocol).

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Viral
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Drug:
• Mefloquine
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
st day: 800 mg of hydroxychloroquine per day, inside, in 200 mg tablets, 2 tablets 2 times a day; nd - 7th day: 400 mg of hydroxychloroquine per day, inside, in tablets of 200 mg, 1 tablet 2 times a day.

Combination Product:
• Mefloquine + azithromycin + / - tocilizumab
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 + / - tocilizumab
st day: 800 mg of hydroxychloroquine per day, inside, in 200 mg tablets, 2 tablets 2 times a day; nd - 7th day: 400 mg of hydroxychloroquine per day, inside, in tablets of 200 mg, 1 tablet 2 times a day.

Locations

Country	Name	City	State
Russian Federation	Burnasyan Federal Medical Biophysical Center FMBA of Russia	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Burnasyan Federal Medical Biophysical Center

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1st primary endpoint for group 1	The number of patients with development of respiratory failure requiring transfer to the ICU.	up to 10 days
Primary	2nd primary endpoint for group 1	The period of clinical recovery.	up to 10 days
Primary	1st primary endpoint for group 2	The period of clinical recovery.	up to 10 days
Primary	2nd primary endpoint for group 2	Frequency of fatal outcomes associated with coronavirus infection disease (COVID19)	through study completion, an average of 3 months
Secondary	1st secondary endpoint for group 1	A change in viral load by conducting PCR assay through different timeframes	on days 5 and 10
Secondary	2nd secondary endpoint for group 1	Frequency of clinical cure on day 10 from the start of therapy	on day 10
Secondary	3d secondary endpoint for group 1	The retention time of the reaction temperature from the start of the treatment.	up to 10 days
Secondary	4th secondary endpoint for group 1	Concentration of C-reactive protein in blood plasma.	up to 10 days
Secondary	5th secondary endpoint for group 1	Respiratory index.	up to 10 days
Secondary	6th secondary endpoint for group 1	Frequency appearance unwanted phenomena and serious unwanted phenomena	up to 10 days
Secondary	1st secondary endpoint for group 2	A change in viral load by conducting PCR assay through different timeframes	on days 5 and 10
Secondary	2nd secondary endpoint for group 2	Respiratory index.	up to 10 days
Secondary	3d secondary endpoint for group 2	The retention time of the reaction temperature from the start of treatment.	up to 10 days
Secondary	4th secondary endpoint for group 2	Concentration of C-reactive protein in blood plasma.	up to 10 days
Secondary	5th secondary endpoint for group 2	Number of patients required transition to alternative therapy schedule	up to 10 days
Secondary	6th secondary endpoint for group 2	Frequency of adverse events and serious adverse events	up to 10 days