Status:
COMPLETED
Clinical Trial of Efficacy and Safety of Raphamin in the Treatment of Coronavirus Disease 2019 in Outpatients
Lead Sponsor:
Materia Medica Holding
Conditions:
Coronavirus Disease 2019 (COVID-19)
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Multicenter double-blind placebo-controlled parallel-group randomized clinical trial of efficacy and safety of Raphamin in the treatment of coronavirus disease 2019 in outpatients.
Detailed Description
Design: multicenter, double blind, placebo-controlled, parallel group randomized clinical trial. The study enrolls outpatients of either gender aged 18-75 years with increased body temperature \> 37....
Eligibility Criteria
Inclusion
- Male and female patients aged 18-75 years old.
- Diagnosis of new coronavirus infection COVID-19 based on medical examination: axillary temperature \>37.5°C, upper respiratory infection symptoms, SpO2 ≥ 95%, no symptoms of moderate or severe forms.
- The minimal baseline score for COVID-19-related symptoms defined as follows: at least two symptoms with a score of 2 or higher, with the exception of taste and smell where subjects may have a score of 1 or higher, and the absence of shortness of breath (difficulty breathing).
- Positive rapid test for for SARS-CoV-2 (COVID-19).
- The first 24 hours from the disease onset.
- Patients giving their consent to use reliable contraception during the study.
- Signed patient information sheet (informed consent form).
Exclusion
- Moderate and severe COVID-19.
- The first four weeks after any vaccination/revaccination, including against COVID-19, influenza, pneumococcal and other infections.
- Suspected pneumonia, bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.).
- Patients requiring medications prohibited within the study.
- Medical history or previously diagnosed primary and secondary immunodeficiency.
- Medical history/suspicion of oncology of any localization (except for benign neoplasms).
- Exacerbation or decompensation of chronic diseases affecting the patient's ability to participate in the clinical study.
- Malabsorption syndrome, including congenital or acquired lactase or disaccharidase deficiency, galactosemia.
- Allergy/ hypersensitivity to any of the components of the medications used in the treatment.
- Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the trial, unwillingness to use contraceptive methods during the trial.
- Use of medications listed in "Prohibited concomitant therapy" within 4 weeks before the study entry.
- Patients who, from the investigator's point of view, will fail to comply with the requirements of the trial or with the intake regimen of the study drugs.
- Medical history of mental diseases, alcoholism or drug abuse which, according to the investigator's opinion, will interfere with the study procedures.
- Participation in other clinical trials within 3 months prior to enrollment in this study.
- The patient is related to the study center staff directly involved in the trial or is the immediate relative of the investigator. Immediate family is defined as a spouse, parents, children or siblings, whether natural or adopted.
- The patient works for OOO "NPF "MATERIA MEDICA HOLDING" i.e. is the company's employee, part-time employee under contract or appointed official in charge of the trial, or their immediate family.
Key Trial Info
Start Date :
April 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2023
Estimated Enrollment :
771 Patients enrolled
Trial Details
Trial ID
NCT05364671
Start Date
April 29 2022
End Date
August 18 2023
Last Update
January 6 2025
Active Locations (36)
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1
Belgorod State National Research University, Department of Hospital Therapy
Belgorod, Russia, 308000
2
Ivanovo clinical hospital named after Kuvaevs/Polyclinic #10
Ivanovo, Russia, 153025
3
Kazan State Medical University, Department of Propedeutics of Internal Diseases named after prof. S.S. Zimnitsky
Kazan', Russia, 420012
4
Kazan State Medical University/Department of Infectious Diseases
Kazan', Russia, 420012