Clinical Trial of Efficacy and Safety of Raphamin in the Treatment of Coronavirus Disease 2019 in Outpatients

NCT05364671 | Completed Phase 3 Results

• 1 other identifier: MMH-407-006
• Study Type: interventional
• Target: 771
• Locations: 1 country
• Sites: 36

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.

Conditions

Coronavirus Disease 2019 (COVID-19)

Outcome Measures

Primary Outcomes (1)

• Number of Participants With COVID-19 Progression to a More Severe Form

  Severity of COVID-19 is assessed in accordance with criteria presented in the current edition of the clinical recommendations of the Ministry of Health of the Russian Federation "Prevention, diagnosis and treatment of a new coronavirus infection (COVID-19)".

  28 days

Secondary Outcomes (2)

• Time to Sustained Clinical Recovery After New Coronavirus Disease COVID-19.

  28 days

• Percentage of Hospitalized Patients

  28 days

Other Outcomes (11)

• Time to COVID-19 Progression to a More Severe Form

  28 days

• Percentage of Patients With Negative PCR Test for SARS-CoV-2

  On days 6 and 10

• Number of Participants With Adverse Events (AEs)

  From day 1 to day 6

Study Arms (2)

Raphamin

EXPERIMENTAL

Tablet for oral use.

Drug: Raphamin

Placebo

PLACEBO COMPARATOR

Tablet for oral use.

Drug: Placebo

Interventions

Raphamin DRUG

Tablet for oral use. The drug is administered not during meals. The tablet should be held in mouth until complete dissolution. On the first day, 8 tablets should be administered using the following regimen: 1 tablet every 30 minutes in the first 2 hours (5 tablets in total within 2 hours), then additionally one tablet 3 times with regular time intervals. From day 2 onwards, 1 tablet taken 3 times daily. The treatment period is 5 days.

Also known as: MMH-407

Raphamin

Placebo DRUG

Tablet for oral use. The drug is administered not during meals. The tablet should be held in mouth until complete dissolution. Placebo is administered according to the Raphamin regimen.

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:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (36)

Belgorod State National Research University, Department of Hospital Therapy

Belgorod, 308000, Russia

Location

Ivanovo clinical hospital named after Kuvaevs/Polyclinic #10

Ivanovo, 153025, Russia

Location

Kazan State Medical University, Department of Propedeutics of Internal Diseases named after prof. S.S. Zimnitsky

Kazan', 420012, Russia

Location

Kazan State Medical University/Department of Infectious Diseases

Kazan', 420012, Russia

Location

Kirov State Medical University, Hospital Therapy Department

Kirov, 610027, Russia

Location

Kuban State Medical University, Infectious Diseases and Phthisiopulmonology

Krasnodar, 350063, Russia

Location

Clinical hospital "RZD-Medicine" of the city of Nizhny Novgorod

Nizhny Novgorod, 603140, Russia

Location

City Clinical Hospital # 2

Novosibirsk, 630051, Russia

Location

Clinical Hospital # 4

Penza, 440067, Russia

Location

LLC "Professor's Clinic"

Perm, 614070, Russia

Location

LLC "Ultrasound Clinic 4D"

Pyatigorsk, 357502, Russia

Location

Ryazan State Medical University named after Academician I.P. Pavlova

Ryazan, 390039, Russia

Location

LLC "BioTechService"

Saint Petersburg, 190121, Russia

Location

City clinic # 44

Saint Petersburg, 192071, Russia

Location

City Polyclinic # 25 of the Nevsky District

Saint Petersburg, 193312, Russia

Location

LLC "Energy of Health"

Saint Petersburg, 194156, Russia

Location

LLC "Strategic medical systems"

Saint Petersburg, 194291, Russia

Location

Llc "Medical Clinic"

Saint Petersburg, 194356, Russia

Location

LLC "Research Center Eco-safety"

Saint Petersburg, 196143, Russia

Location

JSC "North-West Center for Evidence-Based Medicine"

Saint Petersburg, 196158, Russia

Location

LLC "Clinic Zvezdnaya"

Saint Petersburg, 196158, Russia

Location

City Polyclinic # 43

Saint Petersburg, 198207, Russia

Location

Lomonosov Interdistrict Hospital named after I.N. Yudchenko

Saint Petersburg, 198412, Russia

Location

City Intercession Hospital

Saint Petersburg, 199106, 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 "Center for DNA Research"

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

Tver State Medical University

Tver', 170100, Russia

Location

Bashkir State Medical University, Internal Medicine Department

Ufa, 450008, Russia

Location

Voronezh Regional Clinical Hospital # 1

Voronezh, 394066, Russia

Location

Central city hospital

Yaroslavl, 150040, Russia

Location

LLC "Medical Center for Diagnostics and Prevention Plus"

Yaroslavl, 150040, Russia

Location

Central city hospital # 7

Yekaterinburg, 620137, Russia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 6, 2022
• Study Start: April 29, 2022
• Primary Completion: August 18, 2023
• Study Completion: August 18, 2023
• Last Updated: January 6, 2025
• Results First Posted: January 6, 2025

Record last verified: 2023-08

Locations

RU (36)