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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    3600
  • sponsor
    Materia Medica Holding
Updated on 21 October 2021

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)

Description

Design: the multicenter, double-blind, placebo-controlled, parallel-group, randomized trial.

The study will enroll adult participants of either gender aged 18 years who receive a COVID-19 vaccine. The participant signs an information sheet (Informed Consent Form) for participation in the clinical study on the day of administration of component I of the Gam-COVID-Vac (Sputnik-V) vaccine. The physician evaluates if the participant is eligible for the study. A SARS-CoV-2 rapid test (BIOCREDIT COVID-19 Ag) is carried out. If the participant tests positive for SARS-CoV-2, he/she is not enrolled in the study. The investigator's approach should be in compliance with the current version of the guidelines "Prevention, diagnosis, and treatment of a new coronavirus infection (COVID-19)" by the Ministry of Health of the Russian Federation.

If the participant meets all inclusion criteria and does not have any exclusion criteria, then he/she is included in the study, and the physician fills in source medical documentation.

Following enrollment in the study (Day 1, Visit 1), the participant is randomized into one of two groups: participants of the Group 1 receive Ergoferon in the preventive regimen for 3 weeks, and participants of the Group 2 receive Placebo in the same regimen for 3 weeks.

On the day of administration of component II of the Gam-COVID-Vac vaccine (day 22, Visit 2 + 3 days) the express test for SARS-CoV-2 (BIOCREDIT COVID-19 Ag) is performed.

After the component II of the vaccine has been administered, the participant is followed up for 2 weeks. After 2 weeks, Visit 3 ("phone visit") is carried out in order to interview the participant about the health status (absence/presence of any ARVI symptoms).

All participants are provided with classic thermometers for measuring axillary temperature. Electronic diaries are used in the trial to record any potential deterioration in the participant's condition (if applicable) for the assessment of efficacy, safety, and registration of adverse events. The investigator trains the participant how to fill in the diary. Once a week, the participant receives an SMS reminder: "If you have symptoms of the disease, note them in your diary. The investigator will contact you".

If the participant develops symptoms of an acute respiratory viral infection (ARVI)? including an increase in body temperature to febrile/subfebrile values, weakness, headache, chills, cough, sore throat, other symptoms, etc. within five weeks of the observation, the investigator will perform an unscheduled visit to collect nasopharynx and oropharynx swabs for the RT-PCR test (performing in the central laboratory).

If the participant without ARVI symptoms will have a positive test for SARS-CoV-2 (rapid test) at Visit 1 or 2, his/her nasal and oropharyngeal swabs will also be collected for RT-PCR testing in the central laboratory.

If a laboratory-confirmed SARS-CoV-2 infection (with or without symptoms) is detected, the participant will complete the participation in the trial as meeting the primary endpoint.

In case of a positive PCR for SARS-CoV-2, in accordance with the requirements of Rospotrebnadzor Agency, the information about it should be transferred to the medical facility where the participant is registered and where appropriate medical care will be provided for the participant in accordance with the current standards. The employees of the medical facility will report COVID-19 data in compliance with the requirements of the Ministry of Health of the Russian Federation and the rules of the medical facility.

Possible post-vaccination symptoms;

  • general (a flu-like syndrome characterized by chills, fever, arthralgia, myalgia, asthenia, general malaise, headache) and local (pain at the injection site, hyperemia, swelling) reactions that develop on the first-second day and resolve within three subsequent days;
  • nausea, dyspepsia, loss of appetite;
  • enlarged regional lymph nodes;
  • allergic reactions;
  • short-term increase in serum levels of liver transaminases, creatinine, and creatine phosphokinase.

These post-vaccination symptoms are not recorded as adverse events (either associated with the investigational product administration or developing after discontinuation); they are registered by the participant in the diary and assessed by the physician as post-vaccination complications.

The short-term flu-like syndrome should not be diagnosed as ARVI, in this case, the RT-PCR test for SARS-CoV-2 is not performed.

If the participant is ill with COVID-19 or has been hospitalized for COVID-19, a delayed "phone" visit is performed. The visit is scheduled by the investigator depending on each case.

During the study participants are allowed to take medications for their chronic conditions, except for medicines listed as "Prohibited concomitant treatment".

Details
Condition Immunization Against COVID-19
Treatment Placebo, Ergoferon
Clinical Study IdentifierNCT05069649
SponsorMateria Medica Holding
Last Modified on21 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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