Efficacy and Safety of Ergoferon for COVID-19 Prevention During Vaccination Against SARS-CoV-2
Condition: Immunization Against COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

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)
    

Detailed 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".
    

Intervention name(s): Ergoferon; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablet for oral use.; Tablet for oral use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Immunization Against COVID-19 (QC01.9 code is in compliance with ICD-11)