Trial Outcomes & Findings for Study on Safety and Effectiveness of Ergoferon in the Treatment of Flu / ARVI in Outpatients. (NCT NCT04413929)

NCT ID: NCT04413929

Last Updated: 2021-04-02

Results Overview

The time from the onset of treatment with Ergoferon to the resolution of the symptoms, i.e. a body temperature ≤37.0 °С remaining at this level for 24 h (with no further increases throughout the rest of the observation period) in the absence of catarrhal signs and systemic symptoms. Based on Case Report Form data.

• Recruitment status: COMPLETED
• Target enrollment: 8411 participants
• Primary outcome timeframe: through study completion up to 1 month
• Results posted on: 2021-04-02

Participant Flow

Participant milestones

Measure	Ergoferon Oral administration in the therapeutic dosage specified in the instructions for medical use: 8 tablets on the first day of treatment (1 tablet every 30 minutes during the first 2 hours, then 3 more tablet intakes with regular intervals in between);from the second day until recovery take 1 tablet 3 times a day. The duration of the reception was regulated by the physician.
Overall Study STARTED	8411
Overall Study COMPLETED	8411
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Children (age under 18) and adults presented separately. A number of patients did not reported their age (N=337)

Baseline characteristics by cohort

Measure	Ergoferon n=8411 Participants Oral administration in the therapeutic dosage specified in the instructions for medical use.
Age, Continuous All included patients	14.43 years STANDARD_DEVIATION 15.44 • n=8074 Participants • Children (age under 18) and adults presented separately. A number of patients did not reported their age (N=337)
Age, Continuous Adults	36.75 years STANDARD_DEVIATION 14.1 • n=2069 Participants • Children (age under 18) and adults presented separately. A number of patients did not reported their age (N=337)
Age, Continuous Children	6.75 years STANDARD_DEVIATION 4.59 • n=6005 Participants • Children (age under 18) and adults presented separately. A number of patients did not reported their age (N=337)
Sex: Female, Male Female	4220 Participants n=8191 Participants • A number of patients (N=220) did not reported their sex
Sex: Female, Male Male	3971 Participants n=8191 Participants • A number of patients (N=220) did not reported their sex
Region of Enrollment Kazakhstan	2718 Participants n=8411 Participants
Region of Enrollment Uzbekistan	2142 Participants n=8411 Participants
Region of Enrollment Azerbaijan	1015 Participants n=8411 Participants
Region of Enrollment Armenia	390 Participants n=8411 Participants
Region of Enrollment Georgia	329 Participants n=8411 Participants
Region of Enrollment Kyrgyzstan	807 Participants n=8411 Participants
Region of Enrollment Mongolia	451 Participants n=8411 Participants
Region of Enrollment Tajikistan	559 Participants n=8411 Participants

PRIMARY outcome

Timeframe: through study completion up to 1 month

The time from the onset of treatment with Ergoferon to the resolution of the symptoms, i.e. a body temperature ≤37.0 °С remaining at this level for 24 h (with no further increases throughout the rest of the observation period) in the absence of catarrhal signs and systemic symptoms. Based on Case Report Form data.

Outcome measures

Measure	Ergoferon n=8411 Participants Oral administration in the therapeutic dosage specified in the instructions for medical use. Ergoferon: Oral administration
Duration of Influenza/ARVI Symptoms.	4.84 days Standard Deviation 1.53

SECONDARY outcome

Timeframe: through study completion up to 1 month

A body temperature ≥37.0 °С. Based on Case Report Form data.

Outcome measures

Measure	Ergoferon n=8411 Participants Oral administration in the therapeutic dosage specified in the instructions for medical use. Ergoferon: Oral administration
Duration of Increased Body Temperature.	1.99 days Standard Deviation 0.87

SECONDARY outcome

Timeframe: through study completion up to 1 month

Symptoms of intoxication (chills, headache, muscle pain, weakness, loss of appetite).

Based on Case Report Form data.

Outcome measures

Measure	Ergoferon n=8411 Participants Oral administration in the therapeutic dosage specified in the instructions for medical use. Ergoferon: Oral administration
Duration of Systemic Symptoms.	2.33 days Standard Deviation 1.02

SECONDARY outcome

Timeframe: through study completion up to 1 month

Symptoms of the nose (nasal congestion, discharge from the nose), other symptoms. Based on Case Report Form data.

Outcome measures

Measure	Ergoferon n=8411 Participants Oral administration in the therapeutic dosage specified in the instructions for medical use. Ergoferon: Oral administration
Duration of Nose Symptoms.	2.9 days Standard Deviation 1.23

SECONDARY outcome

Timeframe: through study completion up to 1 month

Symptoms of the throat (sore throat, etc.). Based on Case Report Form data.

Outcome measures

Measure	Ergoferon n=8411 Participants Oral administration in the therapeutic dosage specified in the instructions for medical use. Ergoferon: Oral administration
Duration of Throat Symptoms.	2.9 days Standard Deviation 1.3

SECONDARY outcome

Timeframe: through study completion up to 1 month

Patients who got bacterial complications of influenza/acute viral URI, requiring the antibiotics and/or hospitalization during the observation period.

Outcome measures

Measure	Ergoferon n=8411 Participants Oral administration in the therapeutic dosage specified in the instructions for medical use. Ergoferon: Oral administration
Percentage of Patients With Complications of Influenza/Acute Viral URI.	1241 Participants

Adverse Events

Ergoferon

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director

MATERIA MEDICA HOLDING

Phone: +74952761571

Email: PutilovskiyMA@materiamedica.ru

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place