Efficacy and Safety of Ergoferon for COVID-19 Prevention During Vaccination Against SARS-CoV-2

NCT05069649 | Completed Phase 3 Results

• 1 other identifier: MMH-ER-010
• Study Type: interventional
• Target: 1,057
• Locations: 1 country
• Sites: 33

Brief Summary

The multicenter, double-blind, placebo-controlled, parallel-group, randomized clinical trial. The objective of this study is to evaluate the efficacy and safety of Ergoferon as a non-specific preventive medicine for COVID-19 in individuals vaccinated against a new coronavirus infection (SARS-CoV-2)

Conditions

Immunization Against COVID-19

Keywords

Immunization Against COVID-19

Outcome Measures

Primary Outcomes (1)

• The Number of Laboratory-confirmed SARS-CoV-2 Infections.

  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.

  3 weeks

Secondary Outcomes (5)

• The Percentage of Hospitalized Participants With COVID-19.

  3 weeks

• Number of Participants With Adverse Events (AEs)

  3 weeks

• Severity of AEs

  3 weeks

• Causal Relationship of AEs to the Sudy Drug

  3 weeks

• Outcome of AEs

  3 weeks

Study Arms (2)

Ergoferon

EXPERIMENTAL

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.

Drug: Ergoferon

Placebo

PLACEBO COMPARATOR

Tablet for oral use. Placebo using Ergoferon scheme.

Drug: Placebo

Interventions

Ergoferon DRUG

Tablet for oral use.

Ergoferon

Placebo DRUG

Tablet for oral use.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults of either gender aged ≥18 years.
• Participant has not had COVID-19 in the previous 6 months.
• The participant has not been vaccinated against COVID-19 or other viral infections in the previous 6 months.
• Negative rapid test result for SARS-CoV-2 (COVID-19 Ag).
• Absence of clinical manifestations of any infectious disease, but not earlier than 14 days from its onset.
• Consent to use reliable contraceptive methods during the study (for men and women with reproductive potential).
• Presence of a signed information sheet and informed consent form for participation in a clinical trial.

You may not qualify if:

• The presence of contraindications to vaccination:
• hypersensitivity to any component of the vaccine or a vaccine containing similar components;
• prior history of severe allergic reactions;
• acute infectious and non-infectious diseases, exacerbation of chronic diseases.
• Severe chronic hepatic and renal disorders, severe thyroid dysfunction, decompensated diabetes mellitus, severe disorders of the hematopoietic system, epilepsy and other CNS diseases, acute coronary syndrome, acute cerebrovascular accident, myocarditis, endocarditis, pericarditis, autoimmune diseases, or immunodeficiency.
• Malabsorption syndrome, including congenital or acquired lactase deficiency or any other disaccharidase deficiency, galactosemia.
• Hypersensitivity to any of the components of study drug used in the treatment.
• Pregnancy, breast-feeding, childbirth less than 3 months before study enrollment.
• Participants who, from the investigator's point of view, will not comply with study observation requirements or study drug administration procedures.
• Inability to observe the participant during the study period.
• Prior history of mental illness, alcoholism or drug abuse, that the investigator's opinion, will interfere with successful study procedures.
• Participation in other clinical studies within 3 months prior to enrollment in the study.
• Use of any medications listed in "Prohibited concomitant treatment" within 4 weeks before enrollment.
• Participants who are related to any of the on-site research personnel directly involved in the conduct of the trial or are an immediate relative of the study investigator. "Immediate relative" means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).
• Participants who work for OOO "NPF "MATERIA MEDICA HOLDING" (i.e. the company's employees, temporary contract workers, designated officials responsible for carrying out the research or any immediate relatives of the aforementioned).

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (33)

Belgorod State National Research University, Department of Hospital Therapy

Belgorod, 308000, Russia

Location

City Clinical Hospital # 9 of the Ministry of Health of the Udmurt Republic

Izhevsk, 426063, Russia

Location

Baltic Federal University named after Immanuel Kant

Kaliningrad, 236016, Russia

Location

Kazan State Medical University/Department of Internal Diseases

Kazan', 420012, Russia

Location

Republican Clinical Infectious Diseases Hospital named after Prof. A.F. Agafonov

Kazan', 420110, Russia

Location

Kirov State Medical University, Hospital Therapy Department

Kirov, 610027, Russia

Location

Specialized Clinical Infectious Diseases Hospital/Vaccination room

Krasnodar, 350015, Russia

Location

Kuban State Medical University, Infectious Diseases and Phthisiopulmonology

Krasnodar, 350063, Russia

Location

Central Clinical Hospital of the Russian Academy of Sciences

Moscow, 117593, Russia

Location

Llc "Verum Medical"

Moscow, 119285, Russia

Location

Road Clinical Hospital at the station Nizhny Novgorod of JSC Russian Railways

Nizhny Novgorod, 603140, Russia

Location

Clinical Hospital # 4

Penza, 440067, Russia

Location

City Emergency Hospital of Rostov-on-Don

Rostov-on-Don, 344068, Russia

Location

LLC "BioTechService"

Saint Petersburg, 190121, Russia

Location

LLC "Research Center Eco-safety"

Saint Petersburg, 191119, Russia

Location

City Polyclinic # 25 of the Nevsky District

Saint Petersburg, 193312, Russia

Location

LLC "Energy of Health"

Saint Petersburg, 194156, Russia

Location

LLC "Research Center Eco-safety"

Saint Petersburg, 196143, Russia

Location

LLC "Clinic Zvezdnaya"

Saint Petersburg, 196158, Russia

Location

City Polyclinic # 51

Saint Petersburg, 196211, Russia

Location

City Polyclinic # 34

Saint Petersburg, 197198, Russia

Location

City polyclinic #106

Saint Petersburg, 198328, Russia

Location

LLC "Meili"

Saint Petersburg, 199406, Russia

Location

City polyclinic # 74

Saint Petersburg, 97762, Russia

Location

Samara City Hospital # 4

Samara, 443056, Russia

Location

LLC "DNA Research Center"

Saratov, 410005, Russia

Location

Saratov State Medical University named after V. I. Razumovsky

Saratov, 410012, Russia

Location

LLC "Scientific Medical Center for General Therapy and Pharmacology"

Stavropol, 355000, Russia

Location

Bashkir State Medical University, Internal Medicine Department

Ufa, 450008, Russia

Location

Clinical Hospital # 2/Therapeutic department

Yaroslavl, 150030, Russia

Location

Central City Hospital

Yaroslavl, 150040, Russia

Location

Clinical Hospital # 9/Polyclinic #1

Yaroslavl, 150042, Russia

Location

Central City Hospital # 7

Yekaterinburg, 620137, Russia

Location

Related Publications (1)

• Avdeeva MG, Belousova ON, Orlova EA, Khamitov RF, Shvarts YG, Kravchenko IE. [Non-specific prevention of COVID-19 during vaccination against a new coronavirus infection: results of a multicenter, double-blind, placebo-controlled, randomized clinical trial]. Ter Arkh. 2022 Dec 26;94(11):1268-1277. doi: 10.26442/00403660.2022.11.201980. Russian.

  PMID: 37167165 DERIVED

MeSH Terms

Interventions

ergoferon

Results Point of Contact

• Title: Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director
• Organization: MATERIA MEDICA HOLDING

PutilovskiyMA@materiamedica.ru

+74952761571

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 6, 2021
• Study Start: October 6, 2021
• Primary Completion: April 14, 2022
• Study Completion: April 14, 2022
• Last Updated: December 5, 2024
• Results First Posted: December 5, 2024

Record last verified: 2021-11

Locations

RU (33)