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

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: NCT05364671
Recruitment Status : Recruiting
First Posted : May 6, 2022
Last Update Posted : May 6, 2022
Sponsor:
Information provided by (Responsible Party):
Materia Medica Holding

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.

Condition or disease Intervention/treatment Phase
Coronavirus Disease 2019 (COVID-19) Drug: Raphamin Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 838 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 29, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


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

Placebo Comparator: Placebo
Tablet for oral use.
Drug: Placebo
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.




Primary Outcome Measures :
  1. Frequency of COVID-19 progression to a more severe form [ Time Frame: 28 days ]
    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)".


Secondary Outcome Measures :
  1. Time to sustained clinical recovery after new coronavirus disease COVID-19. [ Time Frame: 28 days ]

    Sustained clinical recovery is a sustained improvement of clinical symptoms for at least 4 consecutive days. The day of improvement is considered the first of these 4 days.

    Criteria for improvement of clinical symptoms (according to the scoring system "Assessment of 14 Common COVID-19-Related Symptoms") are defined as follows:

    • a score of 1 or 0 (for stuffy or runny nose, sore throat, low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, nausea, diarrhea);
    • a score 0 (for shortness of breath/difficulty breathing and vomiting);
    • a score no more than 2 (for cough);
    • no new symptoms with a score of 1 or 0;
    • axillary temperature ≤37.3°С.

  2. Percentage of hospitalized patients [ Time Frame: 28 days ]
    Based on the medical records.


Other Outcome Measures:
  1. Time to COVID-19 progression to a more severe form [ Time Frame: 28 days ]
    Severity of COVID-19 will be assessed in accordance with the 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)".

  2. Percentage of patients with negative PCR test for SARS-CoV-2 [ Time Frame: On days 6 and 10 ]
    Based on the medical records.

  3. Adverse events during the treatment, their severity, causality, outcome. [ Time Frame: From day 1 to day 6 ]
    Based on the medical records.

  4. Changes in Vital Signs: Pulse Rate/Heart Rate in Beats per minute (bpm) [ Time Frame: From day 1 to day 6 ]
    The outcome measure is based on the medical records. The patient's heart rate (heart rate) is measured by the physician in visits 1 and 3 (on days 1 and 6).

  5. Changes in Vital Signs: Respiration Rate/Breathing Rate in breaths per minute. [ Time Frame: From day 1 to day 6 ]
    Outcome Measure is based on the medical records. The patient's respiration rate (breathing rate) is measured by physician in visits 1 and 3 (on days 1 and 6).

  6. Changes in Vital Signs: Blood Pressure in units of millimeters of mercury (mmHg). [ Time Frame: From day 1 to day 6 ]
    Outcome Measure is based on the medical records. The patient's blood pressure is measured by the physician in visits 1 and 3 (on days 1 and 6).

  7. Percentage of patients with clinically significant abnormal laboratory tests. [ Time Frame: From day 1 to day 6 ]
    Measure is based on the Hematology, blood chemistry, and urinalysis parameters, which are beyond the reference values at the end of treatment.



Information from the National Library of Medicine

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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. Male and female patients aged 18-75 years old.
  2. 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.
  3. 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).
  4. Positive rapid test for for SARS-CoV-2 (COVID-19).
  5. The first 24 hours from the disease onset.
  6. Patients giving their consent to use reliable contraception during the study.
  7. Signed patient information sheet (informed consent form).

Exclusion Criteria:

  1. Moderate and severe COVID-19.
  2. The first four weeks after any vaccination/revaccination, including against COVID-19, influenza, pneumococcal and other infections.
  3. Suspected pneumonia, bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.).
  4. Patients requiring medications prohibited within the study.
  5. Medical history of or previously diagnosed primary and secondary immunodeficiency.
  6. Medical history/suspicion of oncology of any localization (except for benign neoplasms).
  7. Exacerbation or decompensation of chronic diseases affecting the patient's ability to participate in the clinical study.
  8. Malabsorption syndrome, including congenital or acquired lactase or disaccharidase deficiency, galactosemia.
  9. Allergy/ hypersensitivity to any of the components of the medications used in the treatment.
  10. Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the trial, unwillingness to use contraceptive methods during the trial.
  11. Use of medications listed in "Prohibited concomitant therapy" within 4 weeks before the study entry.
  12. 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.
  13. Medical history of mental diseases, alcoholism or drug abuse which, according to the investigator's opinion, will interfere with the study procedures.
  14. Participation in other clinical trials within 3 months prior to enrollment in this study.
  15. The patient is related to the study center staff directly involved in the trial or is the immediate relative of the investigator. 'Immediate relative' means husband/wife, parents, children, brother/sister regardless of whether they are natural or adopted.
  16. 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.

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): NCT05364671


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: NCT05364671    
Other Study ID Numbers: MMH-407-006
First Posted: May 6, 2022    Key Record Dates
Last Update Posted: May 6, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
COVID-19
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases