Trial Outcomes & Findings for Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Viral Intestinal Infections in Children (NCT NCT03039699)

Last Updated: 2020-10-19

Results Overview

Diarrhea duration is considered as the time between receiving the first dose of investigational medicine /placebo and the normal consistency of stool pattern (to the previous stool consistency before diarrhea), i.e. 1. time to the first loose stool which is followed by two normal consistency stools over 24 h (infants may have three episodes of loose stool over a 24-hour period), or 2. time to ≤3 episodes of stool occurring over 24 h, at least 2 of which are normal consistency stools, or 3. time to the absence of stools for ≥12 h which is not followed by new episodes of diarrhea (total stool frequency over 24 h - less than 3 times).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

259 participants

Primary outcome timeframe

On days 1-10 of observation period.

Results posted on

2020-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	Ergoferon Within the first 2 hours - 1 tablet every 30 minutes, followed by 3 more tablets at time intervals equally separated throughout the rest of the day; from day 2 to day 5 - 1 tablet 3 times daily. Ergoferon	Placebo Within the first 2 hours - 1 tablet every 30 minutes, followed by 3 more tablets at time intervals equally separated throughout the rest of the day; from day 2 to day 5 - 1 tablet 3 times daily. Placebo
Overall Study STARTED	127	132
Overall Study COMPLETED	105	97
Overall Study NOT COMPLETED	22	35

Reasons for withdrawal

Reasons for withdrawal
Measure	Ergoferon Within the first 2 hours - 1 tablet every 30 minutes, followed by 3 more tablets at time intervals equally separated throughout the rest of the day; from day 2 to day 5 - 1 tablet 3 times daily. Ergoferon	Placebo Within the first 2 hours - 1 tablet every 30 minutes, followed by 3 more tablets at time intervals equally separated throughout the rest of the day; from day 2 to day 5 - 1 tablet 3 times daily. Placebo
Overall Study Incorrect inclusion	5	4
Overall Study Lack of data to assess study endpoint	5	3
Overall Study Bacterial infection	12	28

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ergoferon n=127 Participants 1 tablet 3 times a day Ergoferon	Placebo n=132 Participants 1 tablet 3 times a day Placebo	Total n=259 Participants Total of all reporting groups
Age, Categorical <=18 years	127 Participants n=127 Participants	132 Participants n=132 Participants	259 Participants n=259 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=127 Participants	0 Participants n=132 Participants	0 Participants n=259 Participants
Age, Categorical >=65 years	0 Participants n=127 Participants	0 Participants n=132 Participants	0 Participants n=259 Participants
Age, Continuous	2.3 years STANDARD_DEVIATION 1.5 • n=127 Participants	2.3 years STANDARD_DEVIATION 1.4 • n=132 Participants	2.3 years STANDARD_DEVIATION 1.4 • n=259 Participants
Sex: Female, Male Female	50 Participants n=127 Participants	63 Participants n=132 Participants	113 Participants n=259 Participants
Sex: Female, Male Male	77 Participants n=127 Participants	69 Participants n=132 Participants	146 Participants n=259 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Uzbekistan	53 Participants n=127 Participants	56 Participants n=132 Participants	109 Participants n=259 Participants
Region of Enrollment Russia	74 Participants n=127 Participants	76 Participants n=132 Participants	150 Participants n=259 Participants

PRIMARY outcome

Timeframe: On days 1-10 of observation period.

Population: 2 patients in Ergoferon group and 2 patients in Placebo group had no primary outcome data

Outcome measures

Outcome measures
Measure	Ergoferon n=103 Participants 1 tablet 3 times a day Ergoferon	Placebo n=95 Participants 1 tablet 3 times a day Placebo
Average Diarrhea Duration.	43.4 hours Interval 37.9 to 49.0	54.7 hours Interval 49.0 to 60.5

SECONDARY outcome

Timeframe: 48, 72 and 96 hours of the treatment.

Population: 2 patients in Ergoferon group and 2 patients in Placebo group had no primary outcome data

Based on medical records.

Outcome measures

Outcome measures
Measure	Ergoferon n=103 Participants 1 tablet 3 times a day Ergoferon	Placebo n=95 Participants 1 tablet 3 times a day Placebo
Percentage of Patients Without Diarrhea. 48 hours	62 Participants	41 Participants
Percentage of Patients Without Diarrhea. 72 hours	86 Participants	66 Participants
Percentage of Patients Without Diarrhea. 96 hours	98 Participants	88 Participants

SECONDARY outcome

Timeframe: 48, 72 and 96 hours of the treatment.

Population: 2 patients in Ergoferon group and 2 patients in Placebo group had no primary outcome data

Based on medical records. Recovery criteria: absence of diarrhea, vomiting, symptoms of dehydration, and increased body temperature (based on daily examinations by pediatrician).

Outcome measures

Outcome measures
Measure	Ergoferon n=103 Participants 1 tablet 3 times a day Ergoferon	Placebo n=95 Participants 1 tablet 3 times a day Placebo
Percentage of Patients With Recovery. 48 hours	66 Participants	46 Participants
Percentage of Patients With Recovery. 72 hours	88 Participants	68 Participants
Percentage of Patients With Recovery. 96 hours	100 Participants	88 Participants

SECONDARY outcome

Timeframe: On days 1-10 of observation period.

Population: 2 patients in Ergoferon group and 2 patients in Placebo group had no primary outcome data

From the enrollment to the recovery. Recovery criteria: absence of diarrhea, vomiting, symptoms of dehydration, and increased body temperature (based on daily examinations by pediatrician).

Outcome measures

Outcome measures
Measure	Ergoferon n=103 Participants 1 tablet 3 times a day Ergoferon	Placebo n=95 Participants 1 tablet 3 times a day Placebo
Average Illness Duration.	40.8 hours Interval 35.3 to 46.3	53.0 hours Interval 47.2 to 58.9

SECONDARY outcome

Timeframe: 24, 48, and 72 hours of the treatment.

Based on medical records. Clinical Dehydration Scale score is more or equal 1. Note: minimum values - 0 points, maximum values - 8 points. Interpretation: 0 points - no dehydration, from 1 to 4 points - light dehydration, 5-8 points - average/severe dehydration.

Outcome measures

Outcome measures
Measure	Ergoferon n=105 Participants 1 tablet 3 times a day Ergoferon	Placebo n=97 Participants 1 tablet 3 times a day Placebo
Total Clinical Dehydration Scale Score. 24 hours	1.5 score on a scale Interval 1.3 to 1.8	1.5 score on a scale Interval 1.2 to 1.7
Total Clinical Dehydration Scale Score. 48 hours	0.3 score on a scale Interval 0.2 to 0.5	0.3 score on a scale Interval 0.1 to 0.4
Total Clinical Dehydration Scale Score. 72 hours	0.1 score on a scale Interval 0.0 to 0.2	0.1 score on a scale Interval 0.0 to 0.1

SECONDARY outcome

Timeframe: On days 1-10 of observation period.

Population: Vomiting occured in 64.8% patients of Ergoferon group and 71.1% patients of placebo group.

Based on medical records.

Outcome measures

Outcome measures
Measure	Ergoferon n=68 Participants 1 tablet 3 times a day Ergoferon	Placebo n=69 Participants 1 tablet 3 times a day Placebo
Average Vomiting Duration (if Any).	44.6 hours Interval 35.1 to 54.1	57.9 hours Interval 48.4 to 67.5

SECONDARY outcome

Timeframe: On days 3, 4, 6 and 10 of observation period.

Population: PCR tests on days 4, 6 and 10 were run on less patients due to technical issues in laboratory

Based on medical records.

Outcome measures

Outcome measures
Measure	Ergoferon n=81 Participants 1 tablet 3 times a day Ergoferon	Placebo n=71 Participants 1 tablet 3 times a day Placebo
Percentage of Patients With Negative PCR Tests. Day 3	5 Participants	7 Participants
Percentage of Patients With Negative PCR Tests. Day 4	12 Participants	9 Participants
Percentage of Patients With Negative PCR Tests. Day 6	15 Participants	21 Participants
Percentage of Patients With Negative PCR Tests. Day 10	25 Participants	29 Participants

SECONDARY outcome

Timeframe: On days 1-10 of observation period.

Based on medical records. Worsening of illness: an increase in dehydration scores and worsening of non-specific symptoms, as evidenced by a decline in general appearance, increasing fatigue and drowsiness, refusal to eat and drink, severe tachycardia/bradycardia, unstable hemodynamics, tachypnea, hypo- or hyperventilation, circulation disorders, peripheral cyanosis, sunken eyes, severe dryness of skin and mucous/tongue, poor tissue turgor, absent tears, persistent vomiting, anuria/acute kidney injury, seizure/convulsions, and meningismus. Hospital-acquired infection: a viral or bacterial infection (intestinal, respiratory or urinary tract infection, etc.) occurring after at least 48 h of hospital stay and confirmed by laboratory tests.

Outcome measures

Outcome measures
Measure	Ergoferon n=105 Participants 1 tablet 3 times a day Ergoferon	Placebo n=97 Participants 1 tablet 3 times a day Placebo
Percentage of Patients With Worsening of Illness and/or Hospital-acquired Infection.	4 Participants	7 Participants

Adverse Events

Ergoferon

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ergoferon n=127 participants at risk 1 tablet 3 times a day Ergoferon	Placebo n=132 participants at risk 1 tablet 3 times a day Placebo
Infections and infestations Acute respiratory infection	0.79% 1/127 • Number of events 1 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).	0.00% 0/132 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).
Metabolism and nutrition disorders Purine metabolism disorder	0.79% 1/127 • Number of events 1 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).	0.00% 0/132 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).

Other adverse events

Additional Information

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

Materia Medica Holding

Phone: +74952761571

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Ergoferon n=127 participants at risk 1 tablet 3 times a day Ergoferon	Placebo n=132 participants at risk 1 tablet 3 times a day Placebo
Infections and infestations Acute nasopharyngitis	0.00% 0/127 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).	1.5% 2/132 • Number of events 2 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).
Infections and infestations Acute otitis media	0.00% 0/127 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).	0.76% 1/132 • Number of events 1 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).
Infections and infestations Rotavirus infection	0.00% 0/127 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).	0.76% 1/132 • Number of events 1 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).
Infections and infestations Pharyngitis	0.00% 0/127 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).	0.76% 1/132 • Number of events 1 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).
Renal and urinary disorders Leukocytes in urine	0.00% 0/127 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).	0.76% 1/132 • Number of events 1 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).
Infections and infestations Candida Infection	0.79% 1/127 • Number of events 1 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).	0.76% 1/132 • Number of events 1 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).
Blood and lymphatic system disorders Increased levels of ALT	2.4% 3/127 • Number of events 3 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).	0.00% 0/132 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).
Blood and lymphatic system disorders Increased levels of AST	2.4% 3/127 • Number of events 3 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).	0.00% 0/132 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).
Blood and lymphatic system disorders Increase in the percentage of lymphocytes	0.79% 1/127 • Number of events 1 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).	0.00% 0/132 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).
Blood and lymphatic system disorders Neutropenia	1.6% 2/127 • Number of events 2 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).	0.00% 0/132 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).
Infections and infestations Positive test result for staphylococcus	0.79% 1/127 • Number of events 1 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).	0.00% 0/132 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).
Gastrointestinal disorders Hematochezia	0.79% 1/127 • Number of events 1 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).	0.00% 0/132 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).
Psychiatric disorders Sleep disorder	0.79% 1/127 • Number of events 1 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).	0.00% 0/132 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).
Infections and infestations Herpangina caused by Coxsackie virus	0.79% 1/127 • Number of events 1 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).	0.00% 0/132 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).
Infections and infestations Urinary tract infection	0.79% 1/127 • Number of events 1 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).	0.00% 0/132 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).
Renal and urinary disorders Hyperphosphaturia	0.79% 1/127 • Number of events 1 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).	0.00% 0/132 • Adverse/Serious adverse events were collected for 10 days of the therapy and follow-up periods. Adverse/Serious adverse events were collected in patients of the Safety population (n=259).