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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05069649
Recruitment Status : Recruiting
First Posted : October 6, 2021
Last Update Posted : November 29, 2021
Sponsor:
Information provided by (Responsible Party):
Materia Medica Holding

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)


Condition or disease Intervention/treatment Phase
Immunization Against COVID-19 Drug: Ergoferon Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of Ergoferon as Non-specific COVID-19 Prevention During Vaccination Against SARS-CoV-2
Actual Study Start Date : October 6, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: 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.
Drug: Ergoferon
Tablet for oral use.

Placebo Comparator: Placebo
Tablet for oral use. Placebo using Ergoferon scheme.
Drug: Placebo
Tablet for oral use.




Primary Outcome Measures :
  1. The number of laboratory-confirmed SARS-CoV-2 infections. [ Time Frame: 3 weeks ]
    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.


Secondary Outcome Measures :
  1. The percentage of hospitalized participants with COVID-19. [ Time Frame: 3 weeks ]
    Based on medical records.

  2. The presence and nature of AEs. [ Time Frame: 3 weeks ]
    The presence and nature of adverse events, their intensity (severity), causal relationship to the study drug, outcome. Based on medical records.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Malabsorption syndrome, including congenital or acquired lactase deficiency or any other disaccharidase deficiency, galactosemia.
  4. Hypersensitivity to any of the components of study drug used in the treatment.
  5. Pregnancy, breast-feeding, childbirth less than 3 months before study enrollment.
  6. Participants who, from the investigator's point of view, will not comply with study observation requirements or study drug administration procedures.
  7. Inability to observe the participant during the study period.
  8. Prior history of mental illness, alcoholism or drug abuse, that the investigator's opinion, will interfere with successful study procedures.
  9. Participation in other clinical studies within 3 months prior to enrollment in the study.
  10. Use of any medications listed in "Prohibited concomitant treatment" within 4 weeks before enrollment.
  11. 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).
  12. 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05069649


Contacts
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Contact: Mikhail Putilovskiy, MD, PhD +74952761571 ext 302 PutilovskiyMA@materiamedica.ru

Locations
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Sponsors and Collaborators
Materia Medica Holding
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Responsible Party: Materia Medica Holding
ClinicalTrials.gov Identifier: NCT05069649    
Other Study ID Numbers: MMH-ER-010
First Posted: October 6, 2021    Key Record Dates
Last Update Posted: November 29, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Materia Medica Holding:
Immunization Against COVID-19 (QC01.9 code is in compliance with ICD-11)
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases