Trial Outcomes & Findings for Efficacy and Safety of Ergoferon for COVID-19 Prevention During Vaccination Against SARS-CoV-2 (NCT NCT05069649)

Last Updated: 2024-12-05

Results Overview

Based on medical records. The number of laboratory-confirmed SARS-CoV-2 infections (with or without symptoms) in vaccinated individuals throughout the trial. A laboratory-confirmed case will be defined as a case where the novel SARS-CoV-2 coronavirus is detected by RT-PCR in a symptomatic or asymptomatic participant with COVID-19.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1057 participants

Primary outcome timeframe

3 weeks

Results posted on

2024-12-05

Participant Flow

7 participants were not screened because they did not meet the inclusion / non-inclusion criteria.

Participant milestones

Participant milestones
Measure	Ergoferon Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15-30 minutes before meals), keep the tablets in the mouth, without swallowing, until completely dissolved. Ergoferon: Tablet for oral use.	Placebo Tablet for oral use. Placebo using Ergoferon scheme. Placebo: Tablet for oral use.
Overall Study STARTED	526	524
Overall Study COMPLETED	526	524
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ergoferon n=526 Participants Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15-30 minutes before meals), keep the tablets in the mouth, without swallowing, until completely dissolved. Ergoferon: Tablet for oral use.	Placebo n=524 Participants Tablet for oral use. Placebo using Ergoferon scheme. Placebo: Tablet for oral use.	Total n=1050 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=526 Participants	0 Participants n=524 Participants	0 Participants n=1050 Participants
Age, Categorical Between 18 and 65 years	439 Participants n=526 Participants	439 Participants n=524 Participants	878 Participants n=1050 Participants
Age, Categorical >=65 years	87 Participants n=526 Participants	85 Participants n=524 Participants	172 Participants n=1050 Participants
Age, Continuous	45.3 years STANDARD_DEVIATION 17.2 • n=526 Participants	45.0 years STANDARD_DEVIATION 17.0 • n=524 Participants	45.2 years STANDARD_DEVIATION 17.1 • n=1050 Participants
Sex: Female, Male Female	291 Participants n=526 Participants	278 Participants n=524 Participants	569 Participants n=1050 Participants
Sex: Female, Male Male	235 Participants n=526 Participants	246 Participants n=524 Participants	481 Participants n=1050 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Russia	526 participants n=526 Participants	524 participants n=524 Participants	1050 participants n=1050 Participants

PRIMARY outcome

Timeframe: 3 weeks

Outcome measures

Outcome measures
Measure	Ergoferon n=526 Participants Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15-30 minutes before meals), keep the tablets in the mouth, without swallowing, until completely dissolved. Ergoferon: Tablet for oral use.	Placebo n=524 Participants Tablet for oral use. Placebo using Ergoferon scheme. Placebo: Tablet for oral use.
The Number of Laboratory-confirmed SARS-CoV-2 Infections.	7 Participants	22 Participants

SECONDARY outcome

Timeframe: 3 weeks

Based on medical records.

Outcome measures

Outcome measures
Measure	Ergoferon n=526 Participants Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15-30 minutes before meals), keep the tablets in the mouth, without swallowing, until completely dissolved. Ergoferon: Tablet for oral use.	Placebo n=524 Participants Tablet for oral use. Placebo using Ergoferon scheme. Placebo: Tablet for oral use.
The Percentage of Hospitalized Participants With COVID-19.	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 3 weeks

The presence and nature of AEs. Based on medical records.

Outcome measures

Outcome measures
Measure	Ergoferon n=526 Participants Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15-30 minutes before meals), keep the tablets in the mouth, without swallowing, until completely dissolved. Ergoferon: Tablet for oral use.	Placebo n=524 Participants Tablet for oral use. Placebo using Ergoferon scheme. Placebo: Tablet for oral use.
Number of Participants With Adverse Events (AEs)	15 Participants	15 Participants

SECONDARY outcome

Timeframe: 3 weeks

The intensity (severity) and outcomes of adverse events. Mild - AE allows you to perform everyday activities and does not require treatment; Moderate - AE interferes with daily activities and/or requires treatment; Severe - AE makes it impossible to perform daily activities and/or requires the appointment of therapy. Based on medical records.

Outcome measures

Outcome measures
Measure	Ergoferon n=19 Adverse Events (AEs) Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15-30 minutes before meals), keep the tablets in the mouth, without swallowing, until completely dissolved. Ergoferon: Tablet for oral use.	Placebo n=20 Adverse Events (AEs) Tablet for oral use. Placebo using Ergoferon scheme. Placebo: Tablet for oral use.
Severity of AEs Mild	13 number of AE	11 number of AE
Severity of AEs Moderate	5 number of AE	9 number of AE
Severity of AEs Severe	1 number of AE	0 number of AE

SECONDARY outcome

Timeframe: 3 weeks

The causal relationship to the study drug of adverse events. Based on medical records.

Outcome measures

Outcome measures
Measure	Ergoferon n=19 Adverse Events (AEs) Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15-30 minutes before meals), keep the tablets in the mouth, without swallowing, until completely dissolved. Ergoferon: Tablet for oral use.	Placebo n=20 Adverse Events (AEs) Tablet for oral use. Placebo using Ergoferon scheme. Placebo: Tablet for oral use.
Causal Relationship of AEs to the Sudy Drug No relation	14 number of AE	20 number of AE
Causal Relationship of AEs to the Sudy Drug Possible	1 number of AE	0 number of AE
Causal Relationship of AEs to the Sudy Drug Doubtful	3 number of AE	0 number of AE
Causal Relationship of AEs to the Sudy Drug Сonventional	1 number of AE	0 number of AE

SECONDARY outcome

Timeframe: 3 weeks

The outcome of adverse events. Based on medical records.

Outcome measures

Outcome measures
Measure	Ergoferon n=19 Adverse Events (AEs) Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15-30 minutes before meals), keep the tablets in the mouth, without swallowing, until completely dissolved. Ergoferon: Tablet for oral use.	Placebo n=20 Adverse Events (AEs) Tablet for oral use. Placebo using Ergoferon scheme. Placebo: Tablet for oral use.
Outcome of AEs Recovery/resolution	18 number of AE	20 number of AE
Outcome of AEs Incomplete recovery/ resolution	1 number of AE	0 number of AE

Adverse Events

Ergoferon

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ergoferon n=526 participants at risk Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15-30 minutes before meals), keep the tablets in the mouth, without swallowing, until completely dissolved. Ergoferon: Tablet for oral use.	Placebo n=524 participants at risk Tablet for oral use. Placebo using Ergoferon scheme. Placebo: Tablet for oral use.
Cardiac disorders Bradycardia-tachycardia syndrome	0.19% 1/526 • Number of events 1 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.	0.00% 0/524 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.

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=526 participants at risk Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15-30 minutes before meals), keep the tablets in the mouth, without swallowing, until completely dissolved. Ergoferon: Tablet for oral use.	Placebo n=524 participants at risk Tablet for oral use. Placebo using Ergoferon scheme. Placebo: Tablet for oral use.
Gastrointestinal disorders Acute gastritis	0.00% 0/526 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.	0.19% 1/524 • Number of events 1 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.
Gastrointestinal disorders Digestive disorder	0.00% 0/526 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.	0.19% 1/524 • Number of events 1 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.
Gastrointestinal disorders Nausea	0.38% 2/526 • Number of events 2 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.	0.19% 1/524 • Number of events 1 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.
Infections and infestations Viral respiratory tract infection	0.19% 1/526 • Number of events 1 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.	0.19% 1/524 • Number of events 1 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.
Infections and infestations Pneumonia of the right middle lobe	0.19% 1/526 • Number of events 1 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.	0.00% 0/524 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.
Infections and infestations Rhinosinusitis	0.00% 0/526 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.	0.19% 1/524 • Number of events 1 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.
Investigations Increased blood pressure	0.38% 2/526 • Number of events 2 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.	0.76% 4/524 • Number of events 4 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.19% 1/526 • Number of events 1 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.	0.00% 0/524 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.
Respiratory, thoracic and mediastinal disorders Cough	0.19% 1/526 • Number of events 1 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.	0.00% 0/524 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.
Respiratory, thoracic and mediastinal disorders Non-infectious rhinitis	0.00% 0/526 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.	0.19% 1/524 • Number of events 1 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.
Respiratory, thoracic and mediastinal disorders Exertional dyspnea	0.00% 0/526 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.	0.19% 1/524 • Number of events 1 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.
Respiratory, thoracic and mediastinal disorders Sore throat	0.19% 1/526 • Number of events 1 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.	0.00% 0/524 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	0.19% 1/526 • Number of events 1 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.	0.00% 0/524 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.
Immune system disorders Post-vaccination reaction	0.00% 0/526 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.	0.19% 1/524 • Number of events 1 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.
Musculoskeletal and connective tissue disorders Brachialgia	0.19% 1/526 • Number of events 1 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.	0.00% 0/524 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.
Musculoskeletal and connective tissue disorders Lumbar pain	0.19% 1/526 • Number of events 1 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.	0.00% 0/524 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.
Musculoskeletal and connective tissue disorders Back pain	0.19% 1/526 • Number of events 1 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.	0.00% 0/524 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.
Nervous system disorders Headache	0.19% 1/526 • Number of events 1 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.	0.95% 5/524 • Number of events 5 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.
Nervous system disorders Migraine	0.38% 2/526 • Number of events 2 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.	0.00% 0/524 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.
Injury, poisoning and procedural complications Injection site pain	0.19% 1/526 • Number of events 1 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.	0.00% 0/524 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.
General disorders Malaise	0.00% 0/526 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.	0.19% 1/524 • Number of events 1 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.
General disorders General weakness	0.19% 1/526 • Number of events 1 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.	0.00% 0/524 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.
General disorders Precardial pain	0.00% 0/526 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.	0.19% 1/524 • Number of events 1 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.
General disorders Weakness	0.00% 0/526 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.	0.19% 1/524 • Number of events 1 • Registration of AEs begins after taking the first dose of study drug and continues throughout the entire period of patient's participation in the study - 3 weeks.